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QULITY ASSURANCE & QULITY MANAGEMENT CONCEPTS

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QULITY ASSURANCE & QULITY MANAGEMENT CONCEPTS

  1. 1. Quality Assurance and Quality Management concepts BP606T Unit-1 Part-1 (Definition and concept of Quality control, Quality assurance and GMP) Snigdha Rani Behera Associate Professor ARKA JAIN UNIVERSITY
  2. 2. Quality Assurance and Quality Management concepts Definition: Quality is fitness for use and freedom from deficiencies.  Quality is a property which decides excellence or inadequacy (inferiority or superiority) of product or services.  J.M.Juran (1970) who is father of quality research has defined “quality as the performance of the product as per the commitment made by the producer to consumer”.  The quality of a pharmaceutical product is determined by the quality of the raw materials, equipment, and the technical knowledge required to process, package, and distribute the product.  To maintain the quality we need to maintains four parameter.  Quality Management  Quality Assurance  GMP  Quality Control ARKA JAIN University, Jamshedpur, Jharkhand
  3. 3. Quality Control:  A system of maintaining standards in manufactured products by testing a sample of the output against the specification.  It is defined as Process to maintain required quality of product or service. It is a systematic control of various factors that affect the quality of the product.  ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements ".  It is that part of GMP concerned with sampling, specification and testing, documentation and release procedures which ensure that the necessary and relevant tests are performed and the product is released for use only after ascertaining its quality. ARKA JAIN University, Jamshedpur, Jharkhand
  4. 4. Objectives of Quality Control:  Reduced errors and establish quality and standard products.  Analyses extent of quality deviations in process.  Evaluation of methods and process of production.  Promote cost reduction.  Production of quality goods accelerates sale of goods.  Inspire more effective teamwork.  Promotion of exports due to superior and standard quality Production. ARKA JAIN University, Jamshedpur, Jharkhand
  5. 5. Steps of Quality Control QC Labs Sampling Validation Batch Inspection& Sampling Retained Samples Analysis of Finished Product Records ARKA JAIN University, Jamshedpur, Jharkhand
  6. 6. Responsibilities of Quality Control:  QC is responsible for the day-to-day control of quality within the company.  This department is responsible for analytical testing of incoming raw materials and inspection of packaging components, including labeling.  They conduct in-process testing when required, perform environmental monitoring, and inspect operations for compliance.  QC plays a major role in the selection of qualified vendors from whom raw materials are purchased.  The environmental areas for manufacturing of various dosage forms are tested and inspected by QC department. ARKA JAIN University, Jamshedpur, Jharkhand
  7. 7.  Any variation in the quality of a product are mainly due to variations in raw material, personal, methods and procedure of production and inspection.  In order to produce the quality product, these variations need to be checked and controlled.  There are seven types of primary quality control tools. ARKA JAIN University, Jamshedpur, Jharkhand
  8. 8. Methods or Tools of Quality Control Pareto Charts Fishbone diagram/ Ishikawa diagram Check sheets Control charts Stratification Histogram Scatter diagram Flow charts ARKA JAIN University, Jamshedpur, Jharkhand
  9. 9. 1.Pareto Charts:  A Pareto chart, named after Vilfredo Pareto, is a type of chart that contains both bars and a line graph, where individual values are represented in descending order by bars and the cumulative total is represented by the line.  Visual analysis of problems can be done by this type of bar charts so that you can target on most significant issues.  This is the method of organizing errors, problems or defects to help to focus on problem solving efforts. ARKA JAIN University, Jamshedpur, Jharkhand
  10. 10. 2.Fishbone diagram/ Ishikawa diagram:  It is invented by Kaoru Ishikawa.  It is otherwise known as cause and effect diagram.  It helps to determine to which problem is associated, whether it is material, machine , process or Manpower i.e. Personnel. ARKA JAIN University, Jamshedpur, Jharkhand
  11. 11. 3. Check sheet:  It is a simple document that is used for collecting data in real time and location where the data is generated.  The document is typically a blank form that is designed for quick, easy and efficient recording of the desired information, which can be either quantitative or qualitative.  It helps to check crucial material required to manufacture and sell products.  Data checking by checklist is first step in analysis of quality problem. ARKA JAIN University, Jamshedpur, Jharkhand
  12. 12. 4.Control charts:  A control chart is a statistical tool used to distinguish between variation in a process resulting from common causes and variation resulting from special causes.  The charts helps you find and correct problems as they happens, predict a range of out comes and analyze variations. ARKA JAIN University, Jamshedpur, Jharkhand
  13. 13. 5.Stratification:  It simplifies process by separating data so that you can identify problem areas. ARKA JAIN University, Jamshedpur, Jharkhand
  14. 14. 6.Histogram:  It looks very much like a bar chart.  Its graphical method showing bars to recognize defect and frequency of areas. ARKA JAIN University, Jamshedpur, Jharkhand
  15. 15. 7. Scatter diagram:  It show the relationship between two measurements.  If the items are closely related the data points will form a tight band and if a random pattern results, the items are unrelated.  These are often used to determine whether a stated cause truly dose impact the quality characteristics. ARKA JAIN University, Jamshedpur, Jharkhand
  16. 16. 8.Flow chart:  Flow charts are often used to diagram operational procedures to simplify the system.  It shows the sequence of events in a process. ARKA JAIN University, Jamshedpur, Jharkhand
  17. 17. Quality Assurance Quality Assurance :  According to WHO, quality assurance is a wide- ranging concept covering all matters that individually or collectively influence the quality of a product.  Quality Assurance is systematic process to ensure whether a product or service will fulfill their intended quality and desire requirements will be met.  According to ISO 9000 STANDARDS defines QA as “A part of quality management focused on providing confidence that quality requirements will be fulfilled.”  With regard to pharmaceuticals, quality assurance can be divided into major areas: development, quality control, production, distribution, and inspections.(WHO) ARKA JAIN University, Jamshedpur, Jharkhand
  18. 18. Principle of QA:  To ensure that pharmaceutical products are of the quality required for their intended use.  Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.  1. Product should suitable for intended purpose i.e Fit for purpose.  2.Mistakes should be eliminated i.e. Right first time. Objectives of QA:  Supervising good manufacturing Practices. (GMP)  Inspecting good laboratory practices. (GLP)  Monitoring plant environment.  Verifying quality of raw materials.  Verifying the quality of finished product.  Ensure a safety programmed. ARKA JAIN University, Jamshedpur, Jharkhand
  19. 19. Function of QA: Master plan for entire process is prepared. Standards for all raw material and finished products are designed. It provides services to all areas relevant to product quality. Managing and approval of documentations. ARKA JAIN University, Jamshedpur, Jharkhand
  20. 20. Components of QA: Components of QA Strategic Level Tactical Level Operational Level Quality Police Training, Facility, Operation of QA SOP’s Worksheet ARKA JAIN University, Jamshedpur, Jharkhand
  21. 21. Methods for Quality Assurance: There are three methods for Quality Assurance. 1. Failure testing 2. Statistical process control (SPC) 3. Total quality management (TQM) 4. Failure testing:  Testing the product under heat, pressure or vibration to ensure its physical strength .  For software products, failure testing might involve placing the software under high usage or load conditions. 2. Statistical process control (SPC):  It is a method based on objective data and analysis.  It is use to manage and control the production of products.(It is mainly used statistical methods) ARKA JAIN University, Jamshedpur, Jharkhand
  22. 22. 3. Total quality management (TQM): TQM is the integration of all functions and processes to achieve continuous improvement of the quality of goods and services. Responsibilities of QA:  The QA department is responsible for ensuring that the quality policies adopted by a company are followed.  It helps to identify and prepare the necessary SOPs relative to the control of quality.  It must determine that the product meets all the applicable specifications and that it was manufactured according to the internal standards of GMP.  QA also holds responsible for quality monitoring or audit function.  QA functions to assess operations continually and to advise and guide them towards full compliance with all applicable internal and external regulations ARKA JAIN University, Jamshedpur, Jharkhand
  23. 23. Responsibilities of QA:  All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.  The finished product is correctly processed and checked, according to the defined procedures.  Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf- life.  Deviations are reported, investigated and recorded.  There is a system for approving changes that may have an impact on product quality.  Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement. ARKA JAIN University, Jamshedpur, Jharkhand
  24. 24. GMP  Good Manufacturing Practice is a part of quality assurance which ensure that the products are consistently produced and controlled according to quality standards appropriate to their intended use.  A set of principles and procedures which, when followed by manufacturers for the therapeutic goods, helps ensure that the products manufactured will have the required quality.  According to WHO Main principles of GMP is “that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification” .  GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. ARKA JAIN University, Jamshedpur, Jharkhand
  25. 25. The Govt. of India amended the drugs & cosmetics rules 1945 on 24th June 1988 and prescribed GMPs under schedule M. Schedule M has 2 parts i.e. Part-I & Part-II. GMP guidelines comes under Part-I Aim of GMP:  Diminishing the risks inherent in pharmaceutical production, which may broadly be categorized in to  Unexpected contamination of products, causing damage to health or even death.  Incorrect labels on containers, which could mean that patients receive the wrong medicine.  Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. ARKA JAIN University, Jamshedpur, Jharkhand
  26. 26. Objective of GMP:  To produce products confirming to the predetermine specific objective.  To produce product of consistent quality.  To minimize contamination.  To eliminate errors. Components of GMP: ARKA JAIN University, Jamshedpur, Jharkhand
  27. 27. GMP 1.Quality management 2.QA 3.GMP for Medicinal products 4. QC 5.Sanitation & Hygiene 6.Qualification & Validation 7.Complaints & Product recall 8.Contract production & Analysis 9. Self- Inspection, Quality audits & supplier’s audits & approval 10.Personnel & Training 11.Premises 12.Equipme nt 13.Materials 14.Docume ntation 15.Holding & Distribution ARKA JAIN University, Jamshedpur, Jharkhand
  28. 28. 3.GMP for Medicinal products  GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products.  All manufacturing processes are clearly defined, systematically reviewed for associated risks in the light of scientific knowledge and experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications.  Qualification and validation are performed. ARKA JAIN University, Jamshedpur, Jharkhand
  29. 29. 3.GMP for Medicinal products  All necessary resources are provided, including: (i) Sufficient and appropriately qualified and trained personnel, (ii) Adequate premises and space, (iii) Suitable equipment and services, (iv) Appropriate materials, containers and labels, (v) Approved procedures and instructions, (vi) Suitable storage and transport, (vii) Adequate personnel, laboratories and equipment for in-process controls;  SOPs shall be maintained.  All equipment shall be labeled with their current status.  Critical process are validated  Second person verification of activities.  Self- inspection programmed ARKA JAIN University, Jamshedpur, Jharkhand
  30. 30. 4.QC Department:  Quality control responsibility  Testing of Bulk components prior to use by production.  Testing of finished product prior to release for sale.  Stability program.  Review batch records, labels.  Release product, based on QC test results.  Training, auditing.  Customer complaints. ARKA JAIN University, Jamshedpur, Jharkhand
  31. 31. 5.Sanitation & Hygiene  A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of medicines.  The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product.  Potential sources of contamination should be eliminated through an integrated comprehensive programme of sanitation and hygiene. ARKA JAIN University, Jamshedpur, Jharkhand
  32. 32. 5.Personal Hygiene  Health examination.  Before & during employment.  Periodic eye examinations for those who do visual inspection.  Training  Practice in personal hygiene  Written procedures and instructions.  Wash hand before entering production area.  Signs in area (Changing room, Wash areas, Toilet facilities)  Before entering production area use disinfectant.  Direct contact between product and operator should be avoided. ARKA JAIN University, Jamshedpur, Jharkhand
  33. 33. 6.Qualification & Validation  The term Qualification is normally used for equipment, utilities and systems.  Validation is normally used for a processes. So qualification is a part of validation.  Validation requires an appropriate and sufficient infrastructure including organization, documentation, Personnel and finances.  Qualification should be completed before process validation is performed.  A logical, systematic process should be followed.  Start from the design phase of the premises, equipments, utilities and equipment.  Major equipment and critical utilities and systems normally require IQ, OQ and PQ. ARKA JAIN University, Jamshedpur, Jharkhand
  34. 34. 7.Complaints & Product recall  All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken.  A SOP should be available giving full details about how to handle products complaints and necessary records about complaints handled should be maintained.  A person should be designed for handling the complaints and deciding the measures to be taken together with sufficient supporting staff.  If product defect is suspected in a batch, other batches should also be checked in order to determine whether they are also affected.  All decisions and measures taken as a result of a complaint should be recorded.  Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficiency or safety.  Products which are already distributed or sold, may require at times to be recalled from market. ARKA JAIN University, Jamshedpur, Jharkhand
  35. 35. ARKA JAIN University, Jamshedpur, Jharkhand 8.Contract production & Analysis  Contract production, analysis and any other activity covered by GMP must be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a product, or work or analysis, of unsatisfactory quality.  All arrangements for contract production and analysis, including technology transfer and any proposed changes in technical or other arrangements, should be in accordance with the marketing authorization for the product concerned.  The contract should permit the contract giver to audit the facilities and activities of the contract acceptor or mutually agreed subcontractors.  In the case of contract analysis, the final approval for release must be given by the authorized person in accordance with GMP.
  36. 36. 9.Self- Inspection, Quality audits & supplier’s audits & approval  The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and QC.  It should be performed routinely, and may be, in addition, performed on special occasions.  e.g. In the case of product recalls or repeated rejections, or when an inspection by the health authorities is announced.  Quality audit is useful to supplement self-inspections.  quality audit consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it.  The person responsible for QC should have responsibility, together with other relevant departments, for approving suppliers who can reliably supply starting and packaging materials that meet established specifications. ARKA JAIN University, Jamshedpur, Jharkhand
  37. 37. 10.Personnel &Training  The establishment and maintenance of a satisfactory system of QA and the correct manufacture and control of pharmaceutical products and active ingredients rely upon people.  The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience.  Responsible staff should have its specific duties recorded in written descriptions and adequate authority to carry out its responsibilities.  The manufacturer should provide training in accordance with a written programme for all personnel whose duties take them into manufacturing areas or into control laboratories (including the technical, maintenance and cleaning personnel) and for other personnel as required. ARKA JAIN University, Jamshedpur, Jharkhand
  38. 38. 11.Premises  Premises must be located, designed, constructed, adapted and maintained to suit the operations to be carried out.  The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross contamination.  Ancillary areas  Rest and refreshment rooms should be separate from manufacturing and control areas.  Storage areas  It should be of sufficient capacity to allow orderly storage of the various categories of materials and products with proper separation and segregation. ARKA JAIN University, Jamshedpur, Jharkhand
  39. 39. 11.Premises  i.e. from Starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.  Weighing areas  The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas designed for that use.  Production areas:  To minimize the risk of a serious medical hazard due to cross contamination, dedicated and self-contained facilities must be available for the production of particular pharmaceutical products.  Quality control areas  QC laboratories should be separated from production areas. Areas where biological, microbiological or radioisotope test methods are employed should be separated from each other. ARKA JAIN University, Jamshedpur, Jharkhand
  40. 40. 12.Equipment  Equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out.  The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination.  Equipment should be installed in such a way as to minimize any risk of error or of contamination. ARKA JAIN University, Jamshedpur, Jharkhand
  41. 41. 13.Materials  The main objective of a pharmaceutical plant is to produce finished products for patients’ use from a combination of materials (starting and packaging).  Materials include starting materials, packaging materials, gases, solvents, process aids, reagents and labelling materials.  All materials and products should be stored under the appropriate conditions established by the manufacturer, and in an orderly fashion, to permit batch segregation and stock rotation by a. first-expire, first-out rule. ARKA JAIN University, Jamshedpur, Jharkhand
  42. 42. 14.Documentation  Good documentation is an essential part of the quality assurance system and, as such, should exist for all aspects of GMP.  Its aims are to define the specifications and procedures for all materials and methods of manufacture and control.  It ensures the availability of the data needed for validation, review and statistical analysis.  Documents should be designed, prepared, reviewed and distributed with care.  Documents should be approved, signed and dated by the appropriate responsible persons. No document should be changed without authorization and approval. ARKA JAIN University, Jamshedpur, Jharkhand
  43. 43. 15.Holding & Distribution  Storage and distribution are important activities in the supply chain management of medical products.  Products may be subjected to various risks at different stages in the supply chain, i.e. during purchasing, storage, distribution, transportation, re-packaging, and re-labelling.  It is essential to protect the supply chain against the penetration of such products. ARKA JAIN University, Jamshedpur, Jharkhand
  44. 44. THANK YOU STAY SAFE & STAY HEALTHY ARKA JAIN University, Jamshedpur, Jharkhand

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