M.pharm (Pharmaceutics) Modern Pharmaceutics unit- Validation Part-1 introduction, scope and merits of validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipment.
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptxMariaSaifee
The document discusses pharmaceutical validation, including definitions, types, and elements of validation. It provides definitions of validation from WHO, FDA, and ICH. The main types of validation discussed are process validation (prospective, concurrent, retrospective), analytical method validation, equipment validation (design qualification, installation qualification, operational qualification, performance qualification), and revalidation. The key elements of validation discussed are specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, and robustness. Validation is presented as an important part of ensuring consistent and quality pharmaceutical production.
m.pharm (pharmaceutics) modern pharmaceutics- unit 2 validation- part 2 Validation of specific dosage form,
Types of validation. Government regulation, Manufacturing Process Model,
URS, DQ, IQ, OQ & P.Q. of facilities.
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
URS defines the user requirements for a new machine, equipment, or software. The engineering department then prepares the DQ which includes designs, drawings, and samples. Manufacturers will study the DQ and quote a price, or propose design changes. The IQ verifies that the system is installed correctly. The OQ tests that the system functions as specified. Finally, the PQ verifies that the system consistently performs as intended under all operating conditions.
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
Outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs) is common practice to reduce costs and improve efficiency. When selecting a CRO, companies should thoroughly assess the CRO's clinical trial, bioanalytical, pharmacokinetic, and timeline capabilities. Additionally, companies should qualify proposed clinical sites and bioanalytical laboratories and ensure the CRO can provide final reports and data to regulatory agencies like the FDA as required. Proper CRO selection involves due diligence, competitive bidding, and clearly defining deliverables and report requirements.
This document discusses post-approval regulatory affairs for drugs and medical devices. It explains that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved products. Sponsors must comply with post-approval requirements or approval can be withdrawn. Post-approval changes are categorized as major, moderate, or minor depending on their potential effect. Major changes generally require prior approval from the FDA, while moderate changes require notification 30 days before distribution. Minor changes are reported annually. The document provides recommendations for common post-approval changes including components, manufacturing sites, processes, specifications, packaging, and labeling.
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptxMariaSaifee
The document discusses pharmaceutical validation, including definitions, types, and elements of validation. It provides definitions of validation from WHO, FDA, and ICH. The main types of validation discussed are process validation (prospective, concurrent, retrospective), analytical method validation, equipment validation (design qualification, installation qualification, operational qualification, performance qualification), and revalidation. The key elements of validation discussed are specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, and robustness. Validation is presented as an important part of ensuring consistent and quality pharmaceutical production.
m.pharm (pharmaceutics) modern pharmaceutics- unit 2 validation- part 2 Validation of specific dosage form,
Types of validation. Government regulation, Manufacturing Process Model,
URS, DQ, IQ, OQ & P.Q. of facilities.
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
URS defines the user requirements for a new machine, equipment, or software. The engineering department then prepares the DQ which includes designs, drawings, and samples. Manufacturers will study the DQ and quote a price, or propose design changes. The IQ verifies that the system is installed correctly. The OQ tests that the system functions as specified. Finally, the PQ verifies that the system consistently performs as intended under all operating conditions.
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
Outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs) is common practice to reduce costs and improve efficiency. When selecting a CRO, companies should thoroughly assess the CRO's clinical trial, bioanalytical, pharmacokinetic, and timeline capabilities. Additionally, companies should qualify proposed clinical sites and bioanalytical laboratories and ensure the CRO can provide final reports and data to regulatory agencies like the FDA as required. Proper CRO selection involves due diligence, competitive bidding, and clearly defining deliverables and report requirements.
This document discusses post-approval regulatory affairs for drugs and medical devices. It explains that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved products. Sponsors must comply with post-approval requirements or approval can be withdrawn. Post-approval changes are categorized as major, moderate, or minor depending on their potential effect. Major changes generally require prior approval from the FDA, while moderate changes require notification 30 days before distribution. Minor changes are reported annually. The document provides recommendations for common post-approval changes including components, manufacturing sites, processes, specifications, packaging, and labeling.
Current Goods Manufacturing Practice & Industrial ManagementLukman N Kerur
This document provides an overview of CGMP (Current Good Manufacturing Practice) and industrial management. It discusses key aspects of CGMP such as plant layout, services, equipment, production organization, materials management, handling and transportation, inventory management, production planning and control, sales forecasting, budgeting, quality management, and industrial relationships. The objectives of CGMP are to ensure product quality and consistency in manufacturing. Key elements outlined include facilities and equipment requirements, quality control of materials, production systems, and regulatory compliance.
The document discusses the role of Chemistry, Manufacturing, and Controls (CMC) regulatory affairs in managing post-approval changes to drugs. It explains that CMC regulatory affairs professionals work to assure drug quality from clinical trials through marketing by determining the appropriate regulatory submissions for manufacturing changes. They assess proposed changes and provide initial and final responses on whether a prior approval supplement, changes-being-effected supplement, annual report, or no submission is required. This change control process involves interactions with manufacturing and consideration of regulations, guidance, and potential effects on drug quality and equivalence.
Investigation of medicinal product dossier (IMPD)Himal Barakoti
The document discusses the Investigational Medicinal Product Dossier (IMPD) which contains detailed information on the quality, manufacture, and control of investigational medicinal products tested in clinical trials within the European Union. The IMPD is submitted as part of clinical trial authorization applications to regulatory authorities. It includes summaries of non-clinical and clinical data and a risk-benefit assessment. The IMPD requirements are harmonized across EU member states under regulations established by the European Medicines Agency to facilitate multinational clinical trials.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
Evaluation of protein and peptide formulations.pptxDivya Pushp
This document discusses stability testing and evaluation methods for protein formulations. Stability testing ensures products maintain specifications over shelf life under various storage conditions. Evaluations include bioassays to assess potency, which can be in vitro by monitoring cell responses to proteins or in vivo by monitoring animal pharmacological responses. Common evaluation methods are UV spectroscopy, Bradford assay, thermal analysis like DSC and TGA, and chromatography techniques like HPLC, ion exchange, and chromatofocusing.
This document outlines a seminar presentation on Quality by Design (QbD) in pharmaceutical development. It discusses key QbD concepts like the target product profile, critical quality attributes, risk assessment, design space, and control strategy. Tools used in QbD like design of experiments and process analytical technology are also summarized. The document provides an overview of the ICH Q8 guideline on pharmaceutical development and how QbD is viewed by regulators and the pharmaceutical industry.
Optimization techniques in pharmaceutical formulation and processingReshma Fathima .K
This document discusses various optimization techniques used in pharmaceutical formulation and processing. It defines optimization as making something as perfect or effective as possible. The advantages of optimization include reducing costs, saving time, and improving safety, reproducibility, and efficacy. Key optimization parameters discussed include problem type (constrained or unconstrained), variables (independent and dependent), and applied optimization methods like evolutionary operation, simplex method, search method, Lagrangian method, and canonical analysis.
This document discusses single shot vaccines that can provide protection against multiple diseases with only one injection. It describes how single shot vaccines work by combining an antigen, adjuvant, and microsphere component that encapsulates and slowly releases the antigen. Key factors in developing these vaccines include controlling particle size, optimizing encapsulation efficiency, and regulating antigen release from the biodegradable microspheres. Single shot vaccines offer advantages like improved patient compliance and lower costs compared to traditional multi-dose vaccines.
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
Documentation in pharmaceutical industry, by dr. umesh kumar sharma and anu m...Dr. UMESH KUMAR SHARMA
This document discusses various types of documentation required in the pharmaceutical industry. It begins by explaining that documentation provides necessary details to reduce mistakes and batch variations. There are three main types of documents - commitment documents between industry and regulators, directive documents between management and employees, and record documents between employees and their work. Key documents discussed include master formula records, drug master files, distribution records, and generic drug development requirements. The importance of documentation for regulatory compliance and quality assurance is emphasized.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
Theories of dispersion, pharmaceutical dispersion (Emulsion and suspension).pptxDipeshGamare
In this presentation Theories of dispersion, pharmaceutical dispersion (Emulsion and suspension) with their mechanism, methods of preparation and stability studies are mentioned.
The document discusses the regulatory requirements for approval of APIs, biologics, novel drugs, and NDAs. It covers topics such as:
- APIs must be approved through a Drug Master File (DMF) in the US or Active Substance Master File (ASMF) in Europe. A DMF contains confidential manufacturing and quality information for review.
- Biological products like blood components require registration with the FDA and annual listing of manufactured products.
- Approval of novel drugs involves analyzing the medical need and risks/benefits based on clinical trial data, with strategies to manage identified risks.
- The FDA uses various pathways like Fast Track, Breakthrough Therapy, and Accelerated Approval to
The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats used for submitting registration documents to international regulatory agencies. The CTD format organizes documents into 5 modules: Module 1 contains administrative information specific to each region; Module 2 contains summaries of quality, non-clinical, and clinical information; Module 3 contains quality/manufacturing data; Module 4 contains non-clinical study reports; and Module 5 contains clinical study reports. The eCTD format is the electronic version of CTD, with documents in PDF format linked together via an XML backbone for easier navigation and review compared to the paper CTD format.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
This document defines combination products and medical devices and discusses their classification and regulatory requirements. Combination products involve two or more regulated products combined in a single package. Medical devices are instruments or articles used for diagnosis, prevention, monitoring or treatment of disease. The document outlines the classification of medical devices into Classes I-III based on risk and the regulatory pathways of 510(k), reclassification, product development protocol, de novo review, and premarket approval.
1. The document discusses pharmaceutical validation including calibration and validation master plans. It defines validation and calibration, outlines their objectives and importance.
2. It describes the scope and methods of validation including process, analytical, equipment and cleaning validation. It also discusses the merits of validation in ensuring consistency and reducing risks.
3. The document provides details on validation master plans including contents such as introduction, methodology, personnel, schedules, documentation etc. It also discusses calibration master plans, the need for periodic calibration of instruments and maintaining calibration records.
Current Goods Manufacturing Practice & Industrial ManagementLukman N Kerur
This document provides an overview of CGMP (Current Good Manufacturing Practice) and industrial management. It discusses key aspects of CGMP such as plant layout, services, equipment, production organization, materials management, handling and transportation, inventory management, production planning and control, sales forecasting, budgeting, quality management, and industrial relationships. The objectives of CGMP are to ensure product quality and consistency in manufacturing. Key elements outlined include facilities and equipment requirements, quality control of materials, production systems, and regulatory compliance.
The document discusses the role of Chemistry, Manufacturing, and Controls (CMC) regulatory affairs in managing post-approval changes to drugs. It explains that CMC regulatory affairs professionals work to assure drug quality from clinical trials through marketing by determining the appropriate regulatory submissions for manufacturing changes. They assess proposed changes and provide initial and final responses on whether a prior approval supplement, changes-being-effected supplement, annual report, or no submission is required. This change control process involves interactions with manufacturing and consideration of regulations, guidance, and potential effects on drug quality and equivalence.
Investigation of medicinal product dossier (IMPD)Himal Barakoti
The document discusses the Investigational Medicinal Product Dossier (IMPD) which contains detailed information on the quality, manufacture, and control of investigational medicinal products tested in clinical trials within the European Union. The IMPD is submitted as part of clinical trial authorization applications to regulatory authorities. It includes summaries of non-clinical and clinical data and a risk-benefit assessment. The IMPD requirements are harmonized across EU member states under regulations established by the European Medicines Agency to facilitate multinational clinical trials.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
Evaluation of protein and peptide formulations.pptxDivya Pushp
This document discusses stability testing and evaluation methods for protein formulations. Stability testing ensures products maintain specifications over shelf life under various storage conditions. Evaluations include bioassays to assess potency, which can be in vitro by monitoring cell responses to proteins or in vivo by monitoring animal pharmacological responses. Common evaluation methods are UV spectroscopy, Bradford assay, thermal analysis like DSC and TGA, and chromatography techniques like HPLC, ion exchange, and chromatofocusing.
This document outlines a seminar presentation on Quality by Design (QbD) in pharmaceutical development. It discusses key QbD concepts like the target product profile, critical quality attributes, risk assessment, design space, and control strategy. Tools used in QbD like design of experiments and process analytical technology are also summarized. The document provides an overview of the ICH Q8 guideline on pharmaceutical development and how QbD is viewed by regulators and the pharmaceutical industry.
Optimization techniques in pharmaceutical formulation and processingReshma Fathima .K
This document discusses various optimization techniques used in pharmaceutical formulation and processing. It defines optimization as making something as perfect or effective as possible. The advantages of optimization include reducing costs, saving time, and improving safety, reproducibility, and efficacy. Key optimization parameters discussed include problem type (constrained or unconstrained), variables (independent and dependent), and applied optimization methods like evolutionary operation, simplex method, search method, Lagrangian method, and canonical analysis.
This document discusses single shot vaccines that can provide protection against multiple diseases with only one injection. It describes how single shot vaccines work by combining an antigen, adjuvant, and microsphere component that encapsulates and slowly releases the antigen. Key factors in developing these vaccines include controlling particle size, optimizing encapsulation efficiency, and regulating antigen release from the biodegradable microspheres. Single shot vaccines offer advantages like improved patient compliance and lower costs compared to traditional multi-dose vaccines.
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
Documentation in pharmaceutical industry, by dr. umesh kumar sharma and anu m...Dr. UMESH KUMAR SHARMA
This document discusses various types of documentation required in the pharmaceutical industry. It begins by explaining that documentation provides necessary details to reduce mistakes and batch variations. There are three main types of documents - commitment documents between industry and regulators, directive documents between management and employees, and record documents between employees and their work. Key documents discussed include master formula records, drug master files, distribution records, and generic drug development requirements. The importance of documentation for regulatory compliance and quality assurance is emphasized.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
Theories of dispersion, pharmaceutical dispersion (Emulsion and suspension).pptxDipeshGamare
In this presentation Theories of dispersion, pharmaceutical dispersion (Emulsion and suspension) with their mechanism, methods of preparation and stability studies are mentioned.
The document discusses the regulatory requirements for approval of APIs, biologics, novel drugs, and NDAs. It covers topics such as:
- APIs must be approved through a Drug Master File (DMF) in the US or Active Substance Master File (ASMF) in Europe. A DMF contains confidential manufacturing and quality information for review.
- Biological products like blood components require registration with the FDA and annual listing of manufactured products.
- Approval of novel drugs involves analyzing the medical need and risks/benefits based on clinical trial data, with strategies to manage identified risks.
- The FDA uses various pathways like Fast Track, Breakthrough Therapy, and Accelerated Approval to
The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats used for submitting registration documents to international regulatory agencies. The CTD format organizes documents into 5 modules: Module 1 contains administrative information specific to each region; Module 2 contains summaries of quality, non-clinical, and clinical information; Module 3 contains quality/manufacturing data; Module 4 contains non-clinical study reports; and Module 5 contains clinical study reports. The eCTD format is the electronic version of CTD, with documents in PDF format linked together via an XML backbone for easier navigation and review compared to the paper CTD format.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
This document defines combination products and medical devices and discusses their classification and regulatory requirements. Combination products involve two or more regulated products combined in a single package. Medical devices are instruments or articles used for diagnosis, prevention, monitoring or treatment of disease. The document outlines the classification of medical devices into Classes I-III based on risk and the regulatory pathways of 510(k), reclassification, product development protocol, de novo review, and premarket approval.
1. The document discusses pharmaceutical validation including calibration and validation master plans. It defines validation and calibration, outlines their objectives and importance.
2. It describes the scope and methods of validation including process, analytical, equipment and cleaning validation. It also discusses the merits of validation in ensuring consistency and reducing risks.
3. The document provides details on validation master plans including contents such as introduction, methodology, personnel, schedules, documentation etc. It also discusses calibration master plans, the need for periodic calibration of instruments and maintaining calibration records.
Validation Master Plan Modern PharmaceuticsMittalGandhi
The document is a Validation Master Plan that outlines the validation strategy and activities for a manufacturing facility. It includes sections on the introduction, methodology, qualification processes like design, installation, operational, and performance qualification, personnel responsibilities, schedules, change control, documentation, and references. The Validation Master Plan provides an overview of all validation work to be performed to ensure systems, equipment, and processes are qualified and work as intended according to regulatory standards.
The document outlines a Validation Master Plan (VMP) which provides an overview of the validation strategy and activities for a manufacturing facility, including details on design qualification, installation qualification, operational qualification, performance qualification, personnel responsibilities, schedules, documentation requirements, and change control procedures. The VMP describes the purpose and importance of the plan for ensuring all systems, equipment, and processes are qualified and work as intended according to regulatory standards.
1) The Validation Master Plan (VMP) is a comprehensive document describing the validation requirements and plan for a pharmaceutical production facility. It was prepared by Vishal H. Parikh for his professor Ms. Krupa Thula.
2) The VMP includes details on qualification protocols, personnel responsibilities, schedules, documentation requirements, and change control procedures to ensure the facility and processes are appropriately validated.
3) The VMP development process involves identifying regulatory standards and developing protocols for installation, operational, and performance qualification to test facility and equipment operations. The VMP then guides ongoing validation activities and system changes.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
This document discusses validation, including definitions, purposes, types, and processes. It provides details on:
1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
2. Validation is important for new processes and equipment, changes to existing processes/equipment, and where product testing alone cannot ensure quality. It occurs in three phases: pre-validation qualification, process validation, and validation maintenance.
3. A validation master plan is a comprehensive document that describes validation requirements for a facility and provides a validation plan. It covers qualifications, personnel, schedules, and documentation for the validation process.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
This document provides guidelines for conducting manufacturing audits at GKN Driveline plants and suppliers. It outlines procedures for auditing processes, workplaces, and products to verify they meet GKN and customer requirements. Key areas of focus for the audits include process quality planning, incoming material control, in-process control, inspection and testing, traceability, corrective actions, handling, and shipping. Related GKN standards on topics like process control, measurement systems, and record retention are also referenced.
The document discusses validation in the pharmaceutical industry. It begins with an introduction to validation and defines it as documented evidence that a process, equipment, or system consistently produces a product meeting its predetermined specifications and quality attributes. It then covers topics such as why validation is needed, elements of validation like process qualification and equipment qualification, validation protocols, and dosage form validation.
The document discusses various aspects of validation in the pharmaceutical industry. It begins with introducing validation and its importance in assuring quality of pharmaceutical products. It then covers topics such as validation planning, documentation, validation master plan, types of validation including process, cleaning and equipment validation. The document also discusses ICH and WHO guidelines for validation. It highlights the need, merits and demerits of validation as well as who performs validation activities. Finally, it provides an overview of prospective, retrospective and concurrent validation approaches.
The document discusses validation of pharmaceutical processes. It describes the key elements of validation including design qualification, installation qualification, operational qualification and performance qualification. It discusses different types of validation such as prospective validation, concurrent validation and retrospective validation. It also discusses revalidation which is needed when any changes are made that could impact quality. The validation process involves three phases - pre-validation, process validation and validation maintenance. A validation protocol and validation master plan are developed to document the validation activities and ensure a systematic approach.
Complete discussion about the Pharmaceutical validation, its types, difference between calibration and validation, validation master & calibration master plan
Equipment qualification of medical deviceNahri Musyrif
The document defines key terms related to qualification and validation such as qualification, validation, commissioning, and calibration. It discusses classifying systems based on their impact on product quality and determining appropriate qualification approaches. Risk assessments are an important part of qualification and should be conducted according to GMP guidelines. Design, installation, operational, and performance qualifications are described as the key qualification steps. The importance of maintaining qualification status over the lifecycle is also covered.
Nanoparticles have various types and sizes that determine their medical applications. Gold and silver nanoparticles are used in imaging and drug delivery due to their optical properties. Iron oxide nanoparticles are used as MRI contrast agents because they alter the relaxation times of water protons under magnetic fields.
The document discusses the results of a study on the effects of a new drug on memory and cognitive function in older adults. The double-blind study involved giving either the new drug or a placebo to 100 volunteers aged 65-80 over a 6 month period. Testing showed those receiving the drug experienced statistically significant improvements in short-term memory retention and processing speed compared to the placebo group.
DRUG ABSORPTION FROM GASTROINTESTINAL TRACTMehak AggarwAl
MPHARMACY PHARMACEUTICS 2 SEMESTER
ADVANCED BIOPHARMACEUTICS AND PHARMACOKINETICS
UNIT 1 DRUG ABSORPTION FROM GASTROINTESTINAL TRACT
MECHANISM OF DRUG ABSOPTION
Liposomal gene therapy is a promising new approach for treating disease. It works by using liposomes, which are spherical vesicles made of phospholipids, to deliver therapeutic genes directly to cells. The liposomes protect the DNA from degradation and promote cellular uptake of the genes, allowing for expression of therapeutic proteins and potential correction of genetic defects.
Antisense molecules and aptamers are two types of biopharmaceuticals that can be used to treat diseases. Antisense molecules work by binding to messenger RNA to prevent translation into proteins, while aptamers are short strands of nucleic acids or peptides that bind to target molecules with high affinity and specificity. These biopharmaceuticals show promise for developing new therapies and require consideration of their absorption, distribution, metabolism, and excretion to determine clinical effectiveness and safety.
M.pharm (Pharmaceutics) Molecular Pharmaceutics (NTDS) unit 1 part 1 Targeted Drug Delivery Systems: Concepts, Events and biological process involved in drug targeting.
The US Food and Drug Administration (USFDA) is a government agency responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods and feed. The USFDA is part of the United States Department of Health and Human Services.
The Health Insurance Portability and Accountability Act (HIPAA) establishes national standards to protect sensitive patient health information and ensures the security and privacy of health data. It addresses the use and disclosure of individuals' health information and the rights that individuals have to understand and control how their health information is used. HIPAA seeks to strike a balance that permits important uses of information while protecting the privacy of people who seek care and healing.
regulatory affairs m.pharm pharmaceutics - Non clinical drug development: Global submission of IND, NDA, ANDA.
Investigation of medicinal products dossier, dossier (IMPD) and investigator brochure (IB)
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
1) Tablet compression involves the application of force to reduce the volume of powder materials through three main processes: compression, compaction, and consolidation. Compression removes air, compaction rearranges particles, and consolidation increases strength through bonding.
2) Key forces involved in compression include inter-particulate and die wall friction, which can be reduced by adding glidants and lubricants, respectively. Distribution forces transmit pressure from the punches to the powder bed and die wall.
3) Compaction profiles examine the relationship between axial and radial pressure. They provide information on elastic versus plastic deformation and ejection forces.
This document provides an overview of osmotic activated drug delivery systems. It begins with an introduction that explains osmotic pressure is used to release drugs in a controlled manner from these systems. The basic components, advantages, and disadvantages are then outlined. Several types of osmotic pumps are described in detail, including how they work and their applications. In summary, this document serves as a comprehensive review of osmotic drug delivery systems, their design principles, and performance characteristics.
This document discusses enzyme-activated drug delivery systems. It describes how enzymes can directly release drugs from carriers upon site-specific cleavage or facilitate drug release by generating products that alter carrier properties. Typical enzymes discussed include matrix metalloproteinases, phospholipases, and oxidoreductases. Popular carrier approaches activated by enzymes are polymeric nanoparticles, liposomes, and hybrid inorganic/organic nanoparticles. The document provides examples of how each carrier type can be designed to respond to specific enzymes and selectively release drugs.
Bioelectronic medicine involves using tiny implanted devices to treat diseases by modulating neural signals between organs. It works by transmitting electrical impulses along nerve fibers unlike drugs which act through molecular mechanisms. Advantages include targeted treatment with minimal side effects. Applications include diabetes monitoring and cancer treatment. However, high costs and risks of electrical shock remain challenges. Recent advances include vagus nerve implants to regulate the immune system and contact lenses to monitor glucose levels.
Personalized medicine aims to provide the right drug to the right patient at the right time and dose based on their genetic profile. It enables more effective medicines with fewer side effects. Benefits include better drug delivery through avoiding trial and error, reduced costs from quickly identifying clinical trial failures, and improved drug efficiency. Personalized medicine development relies on pharmacogenomics, which studies how genes affect drug response, and pharmacogenetics, which links genotypes to drug metabolism abilities. Factors like age, sex, disease, drug interactions, and genetic polymorphisms influence drug absorption and effects. 3D printing and telemedicine help enable customized drug delivery through remote dispensing and counseling.
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
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𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
Main Java[All of the Base Concepts}.docxadhitya5119
This is part 1 of my Java Learning Journey. This Contains Custom methods, classes, constructors, packages, multithreading , try- catch block, finally block and more.
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Temple of Asclepius in Thrace. Excavation resultsKrassimira Luka
The temple and the sanctuary around were dedicated to Asklepios Zmidrenus. This name has been known since 1875 when an inscription dedicated to him was discovered in Rome. The inscription is dated in 227 AD and was left by soldiers originating from the city of Philippopolis (modern Plovdiv).
How to Make a Field Mandatory in Odoo 17Celine George
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বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
Gender and Mental Health - Counselling and Family Therapy Applications and In...PsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
2. CONTENT
Introduction
Objectives of Validation
Scope & Merits of Validation
Validation Master Plan
Calibration Master Plan
ICH and WHO guidelines for Calibration & Validation of equipment
References
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3. INTRODUCTION
•As per FDA Validation, It is defined as “ establishing a Documented evidence, which provides a
high degree of assurance that a specific process will consistently produce a product meeting its
pre-determined specifications and quality attributes”.
•As per WHO, Validation means providing documented evidence that any procedure, process,
activity or system actually leads to the expected results.
•According to European commission, validation is “Action providing in accordance with the
principles of GMP, that any procedure, process, equipment, material, activity or system actually
lead to the expected results”.
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4. OBJECTIVES
•To reach risk of regulatory non-compliance.
•Reduction of time to the market for the new products.
•Eliminates the scrap and reduces the defect cost.
•To reduce chances of product re-call from market.
•The final release of product batch would be expedited.
•It requires less in-process control and end process testing.
•Parametric release of batch can be achieved in validation.
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5. SCOPE OF VALIDATION
•Pharmaceutical validation is a vast area of work and it practically courses every aspect of pharmaceutical
processing activities, hence defining scope of validation becomes a really difficult task. However, a
systematic look at the pharmaceutical operations will point out at least the following areas for
pharmaceutical validation:
Analytical
Facilities
Manufacturing operations
Product design
Cleaning
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6. MERITS OF VALIDATION
•Knowledge of the process increases during the validation process.
•Consistency of the process is ensured.
•It decrease the risk of the manufacturing problems.
•Ensures the fluency of the production.
•Decrease the expenses.
•Decrease the risk of failing in GMP.
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7. VALIDATION MASTER PLAN
(VMP)
•A validation master plan(VMP) is a comprehensive document describing the
applicable validation requirement for the facility, and providing a plan for the
meeting those requirements.
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8. Scope of VMP
•VMP includes all relevant expects relating to the production of pharmaceuticals in the
production facility. The principle of validation, the organization of qualification and equipment
are also described.
•All facilities used in various production areas, storage, services and the rooms for staff.
In short, it is a documented evidence that provides a high degree of Assurance that a specific
process will consistently produce a product that makes its predetermined specifications and
quality attributes.
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9. Why to perform VMP?
•VMP is not a requirement of FDA, but it has become almost an industry standard.
•It is important to include such a document, as it sets the overall goals and limits that will be followed
during validation and can be referred to throughout the project.
•As a reference document, the plan permits the reviewer immediately to understand the scope of the
validation and avoid misconceptions.
•The validation plan is thus used to set the limits of validation, to define the scope of the project, the
systems included and not included in the qualification and what the project will attempt to prove.
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10. Members of VMP
•Validation manager, QA department
• Member from production
•Member engineering
•Member from calibration lab
•Member from QC lab
•Member from maintenance
•Member from HVAC department
•Member from product development lab
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11. Qualification
•Qualification must be in accordance with the job requirement in combination with experience.
•The resumes of validation team members are presented in a separate folder, including contract help.
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Content of VMP
1. Introduction
•Introduction to validation process and facility.
•Includes- description of facility, premises, equipment, purpose, intension and scope of validation.
12. 2. Methodology
•It addresses pre-determined requirements by identifying standard that are to be applied to facility.
•These are then used in development of the acceptance criteria that are used to judge the validation.
•It involves planning, execution of documents, reports,
Standards involve three elements-
a) Regulatory and guidance document
b) National standard
c) Company standards
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13. 3. Qualification
•This section encompasses all aspects of design, installation and procurement, installation and commissioning process.
4. Personnel
•VMP should lay down the qualification requirements.
•It must address the aspects like experience of personnel, in-house training reports etc.
•Documenting the training is essential and is a requisite of the GMPs.
5. Schedule
•Work program is essential and should be prepared at an early stage. A good plan will contain all necessary features which
are to be considered during execution of a plan and determine control of project.
•It ensures that all personnel involved in VMP are not only aware of engineering targets but also validation targets.
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14. 6. Preventive maintenance
•It is responsibility of site maintenance and operation department.
•This activity should be performed during the design phase and that documentation required should
be, included in the requisition.
7. Procedures
•These cover engineering standards used in project design, through to commissioning phases and the
facilities standard procedures(SOPs).
8. Change control
•Requirements for a set of procedures for change control that cover:
oproject through design, construction and commissioning
o ongoing change that will inevitably occur in both process, equipment and engineering aspects.
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15. 9. Documentation
•Identify the documentation that should be produced for the processing like
oengineering drawing
oEquipment supplier drawing and documents
ofactory acceptance documents
oIQ document
oOQ document
oPQ document
10. Appendices
•Appendix is mostly used VMP to hold information of type of documents and formats that will be used
in execution stage.
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16. CALIBRATION MASTER PLAN
CALIBRATION
•To maintain accuracy and precision of test equipment at all times.
•To ensure the highest level of confidence in all measurement that affect materials deposition decision
with unbroken chain of traceability to national standard.
•To determine whether equipment is still fit for its intended purpose.
•It is based on comparison of a primary standard or instrument of known accuracy with another
equipment (to be calibrated).
• It is used to detect, report or eliminate by adjustment of any variation in the accuracy of equipment
being calibrated.
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17. CMP
•Assigning responsibilities for equipment users, equipment managers, quality assurance personnel and
calibration vendors to help and Shaw company-wide consistency and regulation of your processes.
•Approving calibration vendors such that they are in compliance with the guidelines of your quality
system.
•Identifying and labelling equipment.
•Processing investigations of out of tolerance conditions and other calibration related issues that may
necessitate corrective action.
•Controlling and storing records, including calibration certificates, status change forms and calibration
SOPs.
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18. WHY CALIBRATE?
•Components age and equipment undergoes changes in temperature and humidity or sustains
mechanical stress and therefore their performance degrades. This is called drift. Then test results
become unreliable. While drift cannot be eliminated, it can be detected and either corrected or
compensated for through the process of calibration.
•Calibration:
ooptimizes resources
oensures consistence
oensure measurements
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19. EQUIPMENT CLASSIFICATION
a) Critical equipment
•Direct measurement that affect the final product quality specification.
b) Non-critical equipment
•Indirect measurement that will not directly affect the final product quality.
•Shall be maintained based on company maintenance schedule.
PROCESS OF CALIBRATION
•Calibration process must be managed and executed in a professional manner. A particular place for all calibration
operations to take place and keeping all instruments for calibration.
•Separate room is preferred because
obetter environmental control
obetter protection against unauthorized handling or use of calibration instruments.
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20. •Performance of all calibration operations is assigned as the clear responsibility of just one person.
•Calibration procedures, used for QC function are controlled by International standard ISO 9000. It
required that all persons using calibration equipment be adequately trained.
VERIFICATION
•Applicable to equipment that cannot be calibrated (adjustment, correlation, etc.).
•Verification against measurement standard with correlation factor documented.
•Actual reporting of result shall include the correlation factor-
correlation factor = -2ºC
measured value =24ºC
reported value = 24ºC-2ºC=22ºC
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21. CALIBRATION RECORDS
CMP include the control of all critical measurement equipment that contain the following detail.
•Name
•Identification by model number and serial number
•Location
•Owner/responsible
•Calibration frequency
•Calibration due date
•Calibration certificate
•Calibration procedure
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22. CALIBRATION CERTIFICATE
•Name and address of contracted calibration laboratory.
•Name and address of client.
•Description and identification of item calibrated.
•Environment conditions when calibration was made.
•Date of receipt of instrument, date of calibration and date of next calibration.
•Calibration method.
•Result of calibration.
•Signature and title of person responsible for the calibration.
•External calibration contract shall be awarded to accredited by Nation Institution.
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23. ICH AND WHO GUIDELINES FOR CALIBRATION &
VALIDATION OF EQUIPMENT
ICH GUIDELINES FOR CALIBRATION OF EQUIPMENT
•Local identification by a unique identification number and involvement in master GMP instrument list
•Procedure for instrument history file.
•Approval by quality unit.
•Generation of procedure for verification and standardization of accuracy and reliability.
•For approval of procedure, it must contain steps and forms required for calibration.
•Involvement of calibration stickers and auxiliary stickers program.
•Procedure for tracking of Scheduled calibration activities.
•Procedure for notifying users of calibration due dates, overdue calibrations and out of tolerance findings.
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24. •Review of all systems, calibration records and procedure by quality unit.
•Involvement of procedure for reporting any GMP critical instrument.
•Involvement of calibration forms which are developed to record the calibration results.
WHO GUIDELINES FOR CALIBRATION OF EQUIPMENT
•Regular calibration.
•Establishment of specific procedure of calibration for every equipment.
•Only authorized personnel should operate equipment.
•Availability of up-to-date instructions for calibration verification results must be recorded on a control chart.
•Unique identification of each item of equipment for calibration.
•Keeping of records of each item of equipment to perform calibration.
•Systematic verification of laboratory to prevent contamination.
•Establishment of maintenance procedure.
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25. •Out of service equipment.
•Labelling of equipment.
•Verification of equipment function and calibration status.
EXAMPLE FOR CALIBRATION OF UV SPECTROPHOTOMETER
1. Control of wavelength
• Verify wavelength scale using absorption maxima of holmium per chlorate solution with the line of
hydrogen or deuterium discharge lamp or lines of mercury vapor arc.
•The permitted tolerance is +/-1 nm for the range 200 to 400nm.
2. Control of absorbance
•Check the absorbance using potassium dichromate solution UV at different wavelengths.
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26. 3. Limit of stray light
•Detected at a given wavelength with suitable filters or solutions; for ex. potassium chloride.
4. Resolution power
•Record the spectrum of a 0.02% v/v solution of toluene in hexane UV. Ratio of the absorbance is NLT
1.5 .
5. Spectral slit width
•Spectral slit width must be small compared with the half- width of the absorption band.
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27. ICH GUIDELINES FOR VALIDATION OF EQUIPMENT
•1 meter distance from walls and other obstacles.
•Easy to operate, clean and maintainable.
•Working should be at proper commissioned position.
•Certification of equipment.
•Checking of overhead heights.
•Proper source of light.
•Drop down utility system.
•Design of equipment.
•Layout of equipment.
•Marking of pipelines as per their flow of direction.
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28. •Sop the equipment.
•Tracing of equipment.
•Identification marking for equipment.
•Cleaning of equipment.
•Distinguishing of the equipment.
•Record of each processing.
WHO GUIDELINES FOR VALIDATION OF EQUIPMENT
•Equipment must be located, designed, constructed, adapted and maintained to suit the operation.
•Layout and design of equipment.
•Instalment of equipment.
•Production equipment.
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29. •Labelling of fixed pipe work.
•Cleaning of equipment.
•Labelling of equipment.
•Establishment of written procedures for each operation.
•Record keeping.
EXAMPLE OF VALIDATION OF TABLET COMPRESSION MACHINE
1. Execution of Design
2. Qualification Execution of IQ, OQ and PQ
3. Procedure Followed for Performance Qualification
•The blend/dummy material was unloaded into the hoppers on the both sides and the compression
machine was operated at low speed (20RPM) as per operating instructions. Then the machine was set to
run for 20 minutes continuously after adjusting the following parameters-
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30. oIndividual tablet weight variation
oWeight of 20 tablets
oHardness
oThickness
oDisintegration time
oFriability
•Repeat the procedure at both medium (40RPM) and high speed (60RPM) with same set of parameters.
•Checking of parameters at different speeds.
•Report the results.
•Sampling Plan
1. Collect 100 tablets for every 05 minutes.
2. Compression parameters checked at different speeds.
•Optimum results obtained at 40 rpm speed.
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31. REFERENCES
•Potdar MA, “cGMP, current good manufacturing practises for pharmaceuticals”, 2nd reprint,
Pharmamed press, Hyderabad, p. 85,88-101,413-423.
•Joseph Busfield. cGMP, instrument and calibration. “Facilities, utilities and requirements, GXP, Ivt
network”. Feb 21,2007;5-7. Available from: https://www.ivtnetwork.com/article/cgmp-equipment-
instruments-and-calibration
•Guidelines : ICH. “ICH harmonization for better health”. Available from:
https://www.ich.org/page/ich-guidelines
•Essential medicines and health products information portal. “WHO expert committee on
specifications for pharmaceutical preparations”. World Health Organization.Technical report series
no. 902-36th report.2002.
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