Technology Transfer Related Documents.pptx
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SlideShare Description: Technology Transfer Related Documents Welcome to SlideShare's collection of technology transfer related documents in the field of pharmacy. This presentation focuses on the essential documentation needed for successful technology transfer in pharmaceutical manufacturing, emphasizing its role in ensuring quality, safety, and regulatory compliance. Technology transfer plays a crucial role in the dynamic and ever-evolving field of pharmacy. It facilitates the smooth transfer of knowledge, processes, and technologies from research and development to commercial production. To ensure a seamless transition, a well-defined set of documents is required to capture critical information, procedures, and controls. This SlideShare presentation explores the key documents involved in technology transfer within the pharmaceutical industry. The technology transfer protocol is discussed first, highlighting its purpose, contents, and significance. Acting as a roadmap, this protocol outlines the transfer scope, stakeholder responsibilities, timelines, and acceptance criteria, promoting effective communication and collaboration between the sending and receiving units. The importance of comprehensive process descriptions is also emphasized. These documents detail the manufacturing process, equipment specifications, critical parameters, and in-process controls. They serve as a guide for the receiving unit to replicate the process accurately, ensuring consistent product quality and performance. Validation and qualification protocols are addressed as well, highlighting their role in verifying that equipment, processes, and systems are suitable for their intended use. These protocols are crucial for meeting regulatory requirements and mitigating risks associated with the transfer. Analytical method transfer documents are discussed next, encompassing the procedures for transferring and validating analytical methods used to assess the quality attributes of pharmaceutical products. Robust analytical methods are essential to ensure accurate and reliable test results throughout the product lifecycle. The presentation also covers documentation related to training, risk assessments, change control, and deviation management. These documents help establish a robust quality management system, ensuring adherence to regulatory standards and facilitating continuous improvement. Whether you're involved in technology transfer, quality assurance, or regulatory affairs, this SlideShare is a valuable resource for understanding the essential documents involved in successful technology transfer within the pharmaceutical industry. By leveraging these documents effectively, you can ensure a seamless transfer process, maintain product quality, and uphold patient safety. Explore our SlideShare and gain the knowledge necessary to navigate the intricacies of technology transfer in pharmacy. Stay updated with the latest best practices and regulatory guidelines.
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Recommandé
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCT
The document discusses the Certificate of Pharmaceutical Product (CoPP), which is issued by regulatory authorities to help importing countries assess the quality of pharmaceutical products. It outlines the importance of the CoPP for product registration in other countries. The summary also describes the application process for obtaining a CoPP in India, including requirements for documentation, inspections, and the format of the certificate.
Certificate of pharmaceutical product
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Six sigma
This document provides an overview of pharmaceutical quality management. It discusses topics like total quality management (TQM), six sigma, and quality management principles. TQM focuses on customer satisfaction and continuous process improvement. It has six basic concepts and six "C's". Six sigma uses statistical methods like DMAIC and DMADV to reduce defects and variability in processes. The document also outlines fundamentals of quality management, including quality planning, assurance, control and improvement to ensure consistency. Key quality gurus who advanced these concepts are also mentioned.
Technology transfer (tt) agencies in India
The document discusses various agencies involved in technology transfer in India. It provides details on 6 key agencies:
1) APCTD - A UN agency that promotes technology transfer between countries in Asia and the Pacific.
2) NRDC - India's premier organization for commercializing technologies from universities and research institutions. It has licensed over 4,500 technologies.
3) TIFAC - Set up under the Department of Science and Technology to identify and implement technology projects to further goals of developing India.
4) BCIL - A public company set up to support biotechnology transfer, consulting, funding and training. It assists with commercializing academic technologies.
5) TBSE - Provides funding and consulting for small businesses
Supac
SUPAC respresents the changes recommended by US FDA at the time of scale up or approval of NDA / ANDA
Pilot plant Techniques and Product consideration for liquid dosage forms.
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Granularity of tt pro.
The document discusses the level of detail that should be provided about active pharmaceutical ingredients (APIs), excipients, finished products, and packaging materials when transferring technology from a source unit (SU) to a recipient unit (RU). For APIs, the SU should provide information such as the manufacturer, synthesis process, impurities, and stability studies. For excipients, the SU should detail the manufacturer, category, properties like solubility, and specifications for different dosage forms. The finished product specifications, storage conditions, and analytical test procedures should also be transferred. Finally, the SU should inform the RU about the suitable packaging, labeling, and ensure the packaging will not degrade the product.
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
The document provides an overview of regulatory affairs (RA) in the pharmaceutical industry. It discusses that RA ensures pharmaceutical products comply with regulatory standards by acting as the link between companies and regulatory authorities. RA is responsible for guiding drug development and submissions for market approval. The document outlines the historical development of regulations from 1900 to present day. It also reviews the roles and responsibilities of RA professionals which include maintaining knowledge of regulations, preparing submissions, and ensuring compliance. Finally, it lists some major regulatory authorities around the world and their roles in overseeing drug development and approval processes.
Recommandé
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCT
The document discusses the Certificate of Pharmaceutical Product (CoPP), which is issued by regulatory authorities to help importing countries assess the quality of pharmaceutical products. It outlines the importance of the CoPP for product registration in other countries. The summary also describes the application process for obtaining a CoPP in India, including requirements for documentation, inspections, and the format of the certificate.
Certificate of pharmaceutical product
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Six sigma
This document provides an overview of pharmaceutical quality management. It discusses topics like total quality management (TQM), six sigma, and quality management principles. TQM focuses on customer satisfaction and continuous process improvement. It has six basic concepts and six "C's". Six sigma uses statistical methods like DMAIC and DMADV to reduce defects and variability in processes. The document also outlines fundamentals of quality management, including quality planning, assurance, control and improvement to ensure consistency. Key quality gurus who advanced these concepts are also mentioned.
Technology transfer (tt) agencies in India
The document discusses various agencies involved in technology transfer in India. It provides details on 6 key agencies:
1) APCTD - A UN agency that promotes technology transfer between countries in Asia and the Pacific.
2) NRDC - India's premier organization for commercializing technologies from universities and research institutions. It has licensed over 4,500 technologies.
3) TIFAC - Set up under the Department of Science and Technology to identify and implement technology projects to further goals of developing India.
4) BCIL - A public company set up to support biotechnology transfer, consulting, funding and training. It assists with commercializing academic technologies.
5) TBSE - Provides funding and consulting for small businesses
Supac
SUPAC respresents the changes recommended by US FDA at the time of scale up or approval of NDA / ANDA
Pilot plant Techniques and Product consideration for liquid dosage forms.
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Granularity of tt pro.
The document discusses the level of detail that should be provided about active pharmaceutical ingredients (APIs), excipients, finished products, and packaging materials when transferring technology from a source unit (SU) to a recipient unit (RU). For APIs, the SU should provide information such as the manufacturer, synthesis process, impurities, and stability studies. For excipients, the SU should detail the manufacturer, category, properties like solubility, and specifications for different dosage forms. The finished product specifications, storage conditions, and analytical test procedures should also be transferred. Finally, the SU should inform the RU about the suitable packaging, labeling, and ensure the packaging will not degrade the product.
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
The document provides an overview of regulatory affairs (RA) in the pharmaceutical industry. It discusses that RA ensures pharmaceutical products comply with regulatory standards by acting as the link between companies and regulatory authorities. RA is responsible for guiding drug development and submissions for market approval. The document outlines the historical development of regulations from 1900 to present day. It also reviews the roles and responsibilities of RA professionals which include maintaining knowledge of regulations, preparing submissions, and ensuring compliance. Finally, it lists some major regulatory authorities around the world and their roles in overseeing drug development and approval processes.
Supac
This document provides guidelines for scale-up and post-approval changes (SUPAC) as outlined by the FDA. It discusses SUPAC documents, levels of changes, and recommendations for changes to components and composition, manufacturing site, batch size, and manufacturing process and equipment. The guidelines provide recommendations for submitting documentation to the FDA for level 1, 2, and 3 changes to ensure quality and performance of drug products after approval. It notes some limitations of the SUPAC guidelines, including that they have not been updated since 1995/1997 and do not cover all potential changes.
Documentation of technology Transfer .pptx
This document outlines the various protocols and reports required for technology transfer between pharmaceutical companies. It discusses confidentiality agreements, licensing, research and development reports, technology transfer plans, process validation protocols, equipment and facility qualification protocols, cleaning validation protocols, and analytical methods transfer protocols. The goal of technology transfer is to ensure that manufacturing capabilities, methods, and intellectual property are effectively transferred between parties in a controlled and documented manner.
Pilot Plant Techniques for SOLID dosage forms
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
WHO Guidance on Technology Transfers
The document provides guidance on technology transfer between pharmaceutical manufacturing sites. It discusses that technology transfer requires a documented, planned approach with trained personnel and quality systems. A successful transfer involves the sending unit providing documentation to the receiving unit, conducting training, and jointly executing a transfer protocol. The receiving unit must demonstrate it can routinely reproduce the product or process to specifications. The guidance addresses general principles, planning, information to be transferred for active pharmaceutical ingredients and excipients, process validation, and assessing a successful transfer.
Technology development & transfer by devill
The document discusses key aspects of technology transfer between a sending unit and receiving unit. It defines technology transfer and lists requirements such as a documented approach, trained personnel, and quality documentation. It also defines terms related to quality assurance in technology transfer, including active pharmaceutical ingredients, good manufacturing practices, process validation, and more. Finally, it provides guidance on aspects of technology transfer including developing a transfer protocol, specifications for starting materials, and information that should be transferred about APIs and excipients.
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
The document discusses Indian regulatory requirements for drugs, including the Central Drugs Standard Control Organization (CDSCO) which regulates drugs, cosmetics, diagnostics and devices in India. CDSCO is headed by the Drug Controller General of India and oversees functions like new drug approval, clinical trials, good manufacturing practices, and state licensing. It provides an overview of the application and approval process for new drugs in India.
NEW DRUG APPLICATION ( NDA)
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
Regulatory requirements for drug approval
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
Granularity of TT Process.pdf
This document discusses the key aspects of technology transfer between a sending unit and receiving unit. It outlines the types of documentation, analytical methods, equipment, and facilities information that should be provided to properly transfer a manufacturing process. This includes details on APIs, excipients, finished products, packaging, cleaning procedures, and quality control testing. The roles and responsibilities of both units are defined to ensure a successful technology transfer.
Scale up and post approval changes(supac)
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
Supac
The document discusses Supplemental Abbreviated Changes to an Approved Application (SUPAC) guidelines for post-approval changes to pharmaceutical drug products. It defines three levels of changes - minor, moderate, and major - and provides recommendations for documentation and necessary filings based on the level of change for components/composition, manufacturing equipment, processes, batch size, and site changes. Minor changes may only require annual reporting, while major changes involving new excipients, processes, or sites would necessitate prior approval supplements and additional testing.
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.
This document provides information about technology transfer in the pharmaceutical industry. It defines technology transfer as the logical procedure that controls the transfer of any process along with documentation and expertise between development and manufacturing sites. The WHO guidelines for technology transfer provide a flexible framework to guide the transfer process with a focus on quality. The scope of the WHO guidelines includes guidance for transferring manufacturing processes of APIs, packaging, and all dosage forms. Reasons for technology transfer include a lack of manufacturing capacity, resources, or marketing capabilities.
Quality management systems - INDUSTRIAL PHARMACY ll
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Mucosal drug delivery system
mucosal drug delivery is a developing system nowadays due to its several advantages including patient compliance and for sustained delivery
Quality Risk Management
This document discusses quality risk management (QRM) in the pharmaceutical industry. It begins by introducing QRM and its importance in ensuring quality systems. The document then outlines the scope of QRM, including its application across various stages of drug development and manufacturing. The core principles and process of QRM are described, including risk assessment, control, communication, and review. Various risk management tools are also introduced. Finally, the document discusses integrating QRM into industry and regulatory operations to facilitate consistent decision making.
Pilot plant Scale Up Techniques: General considerations
This document discusses general considerations for pilot plant scale up techniques. It outlines 12 key areas that should be considered when scaling up a formulation from the laboratory to a pilot plant scale, including reporting responsibilities, personnel requirements, space requirements, reviewing the formula, raw materials, processing equipment, production rates, process evaluation, manufacturing procedures, product stability and uniformity, GMP compliance, and transferring analytical methods to quality assurance. The goal is to produce a formulation on an intermediate batch scale that represents the procedures used for commercial manufacturing.
Drug development team
Drug discovery project team, preclinical drug development project team, clinical drug development team
Approaches Of Gastro-Retentive Drug Delivery System or GRDDS
Approaches Of Gastro-Retentive Drug Delivery System
Includes:
Floating and Non-Floating drug delivery system with their subtypes
Like Non-effervescent system, Effervescent system, Raft forming system,
High Density system, Expandable system, Muco-adhesive system,
Super porous hydrogel system and Magnetic Systems, etc.
Technology transfer.pptx
WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging, and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT-related documentation - confidentiality agreement, licensing, MoUs, legal issues
Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
B. Pharm. Final Year, Sem:- VII, INDUSTRIAL PHARMACY-II,
Unit 2 chapter 2 Technology development and transfer,
As per PCI Syllabus
technology transfer documents confidentiality agreements, licensing, mous.pdf
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
Utility models
Utility models provide exclusive rights similar to patents but with shorter terms of protection (usually 7-10 years) and lower filing costs. Unlike patents, utility models do not require examination for novelty or inventiveness prior to registration. While patents protect inventions, utility models can protect products or processes depending on the jurisdiction. Technology transfer agreements facilitate the application of technologies developed for one purpose to new uses or users, and generally involve the transfer of various types of technical knowledge through licensing. India's policies aim to promote both indigenous technology development and regulated technology imports through transfer agreements within approved payment limits and royalty periods.
Contenu connexe
Tendances
Supac
This document provides guidelines for scale-up and post-approval changes (SUPAC) as outlined by the FDA. It discusses SUPAC documents, levels of changes, and recommendations for changes to components and composition, manufacturing site, batch size, and manufacturing process and equipment. The guidelines provide recommendations for submitting documentation to the FDA for level 1, 2, and 3 changes to ensure quality and performance of drug products after approval. It notes some limitations of the SUPAC guidelines, including that they have not been updated since 1995/1997 and do not cover all potential changes.
Documentation of technology Transfer .pptx
This document outlines the various protocols and reports required for technology transfer between pharmaceutical companies. It discusses confidentiality agreements, licensing, research and development reports, technology transfer plans, process validation protocols, equipment and facility qualification protocols, cleaning validation protocols, and analytical methods transfer protocols. The goal of technology transfer is to ensure that manufacturing capabilities, methods, and intellectual property are effectively transferred between parties in a controlled and documented manner.
Pilot Plant Techniques for SOLID dosage forms
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
WHO Guidance on Technology Transfers
The document provides guidance on technology transfer between pharmaceutical manufacturing sites. It discusses that technology transfer requires a documented, planned approach with trained personnel and quality systems. A successful transfer involves the sending unit providing documentation to the receiving unit, conducting training, and jointly executing a transfer protocol. The receiving unit must demonstrate it can routinely reproduce the product or process to specifications. The guidance addresses general principles, planning, information to be transferred for active pharmaceutical ingredients and excipients, process validation, and assessing a successful transfer.
Technology development & transfer by devill
The document discusses key aspects of technology transfer between a sending unit and receiving unit. It defines technology transfer and lists requirements such as a documented approach, trained personnel, and quality documentation. It also defines terms related to quality assurance in technology transfer, including active pharmaceutical ingredients, good manufacturing practices, process validation, and more. Finally, it provides guidance on aspects of technology transfer including developing a transfer protocol, specifications for starting materials, and information that should be transferred about APIs and excipients.
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
The document discusses Indian regulatory requirements for drugs, including the Central Drugs Standard Control Organization (CDSCO) which regulates drugs, cosmetics, diagnostics and devices in India. CDSCO is headed by the Drug Controller General of India and oversees functions like new drug approval, clinical trials, good manufacturing practices, and state licensing. It provides an overview of the application and approval process for new drugs in India.
NEW DRUG APPLICATION ( NDA)
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
Regulatory requirements for drug approval
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
Granularity of TT Process.pdf
This document discusses the key aspects of technology transfer between a sending unit and receiving unit. It outlines the types of documentation, analytical methods, equipment, and facilities information that should be provided to properly transfer a manufacturing process. This includes details on APIs, excipients, finished products, packaging, cleaning procedures, and quality control testing. The roles and responsibilities of both units are defined to ensure a successful technology transfer.
Scale up and post approval changes(supac)
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
Supac
The document discusses Supplemental Abbreviated Changes to an Approved Application (SUPAC) guidelines for post-approval changes to pharmaceutical drug products. It defines three levels of changes - minor, moderate, and major - and provides recommendations for documentation and necessary filings based on the level of change for components/composition, manufacturing equipment, processes, batch size, and site changes. Minor changes may only require annual reporting, while major changes involving new excipients, processes, or sites would necessitate prior approval supplements and additional testing.
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.
This document provides information about technology transfer in the pharmaceutical industry. It defines technology transfer as the logical procedure that controls the transfer of any process along with documentation and expertise between development and manufacturing sites. The WHO guidelines for technology transfer provide a flexible framework to guide the transfer process with a focus on quality. The scope of the WHO guidelines includes guidance for transferring manufacturing processes of APIs, packaging, and all dosage forms. Reasons for technology transfer include a lack of manufacturing capacity, resources, or marketing capabilities.
Quality management systems - INDUSTRIAL PHARMACY ll
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Mucosal drug delivery system
mucosal drug delivery is a developing system nowadays due to its several advantages including patient compliance and for sustained delivery
Quality Risk Management
This document discusses quality risk management (QRM) in the pharmaceutical industry. It begins by introducing QRM and its importance in ensuring quality systems. The document then outlines the scope of QRM, including its application across various stages of drug development and manufacturing. The core principles and process of QRM are described, including risk assessment, control, communication, and review. Various risk management tools are also introduced. Finally, the document discusses integrating QRM into industry and regulatory operations to facilitate consistent decision making.
Pilot plant Scale Up Techniques: General considerations
This document discusses general considerations for pilot plant scale up techniques. It outlines 12 key areas that should be considered when scaling up a formulation from the laboratory to a pilot plant scale, including reporting responsibilities, personnel requirements, space requirements, reviewing the formula, raw materials, processing equipment, production rates, process evaluation, manufacturing procedures, product stability and uniformity, GMP compliance, and transferring analytical methods to quality assurance. The goal is to produce a formulation on an intermediate batch scale that represents the procedures used for commercial manufacturing.
Drug development team
Drug discovery project team, preclinical drug development project team, clinical drug development team
Approaches Of Gastro-Retentive Drug Delivery System or GRDDS
Approaches Of Gastro-Retentive Drug Delivery System
Includes:
Floating and Non-Floating drug delivery system with their subtypes
Like Non-effervescent system, Effervescent system, Raft forming system,
High Density system, Expandable system, Muco-adhesive system,
Super porous hydrogel system and Magnetic Systems, etc.
Technology transfer.pptx
WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging, and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT-related documentation - confidentiality agreement, licensing, MoUs, legal issues
Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
B. Pharm. Final Year, Sem:- VII, INDUSTRIAL PHARMACY-II,
Unit 2 chapter 2 Technology development and transfer,
As per PCI Syllabus
Tendances (20)
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Quality management systems - INDUSTRIAL PHARMACY ll
Quality management systems - INDUSTRIAL PHARMACY ll
Pilot plant Scale Up Techniques: General considerations
Pilot plant Scale Up Techniques: General considerations
Approaches Of Gastro-Retentive Drug Delivery System or GRDDS
Approaches Of Gastro-Retentive Drug Delivery System or GRDDS
Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
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technology transfer documents confidentiality agreements, licensing, mous.pdf
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
Utility models
Utility models provide exclusive rights similar to patents but with shorter terms of protection (usually 7-10 years) and lower filing costs. Unlike patents, utility models do not require examination for novelty or inventiveness prior to registration. While patents protect inventions, utility models can protect products or processes depending on the jurisdiction. Technology transfer agreements facilitate the application of technologies developed for one purpose to new uses or users, and generally involve the transfer of various types of technical knowledge through licensing. India's policies aim to promote both indigenous technology development and regulated technology imports through transfer agreements within approved payment limits and royalty periods.
Ch 14.3
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Technology Transfer Agreements Regulation in Ghana
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Alteration of Patent Protection Length in the Intellectual Property Provision...
The document summarizes and analyzes key provisions around patent protection length in the intellectual property chapter of the Trans-Pacific Partnership (TPP) agreement. Specifically:
- The TPP IP chapter would require countries to provide patents in all fields of technology and extend patentability to plants/animals and medical procedures, going beyond existing agreements.
- It allows compensation for "unreasonable delays" in patent approval/marketing approval to extend patent terms beyond 20 years.
- While promoting access to medicines, critics argue these expanded patent rights could weaken competition and increase drug costs, reducing access to affordable treatments.
Philippine Franchising Law
Philippine Contract Law and Intellectual Property Law serve as the applicable laws on Franchising. Currently, there is no specific law on Franchising that regulates the agreements between the Franchisor and the Franchisee.
Patent License Types.pdf
Patent licenses are agreements that allow others to use patented technologies and are necessary for innovation and commercialization. There are several types of patent licenses: exclusive licenses grant sole use of the technology to the licensee; non-exclusive licenses allow the licensor to license to others; sole licenses provide exclusive use but allow the licensor to also use; and field-of-use licenses restrict use to a particular application. Cross-licenses allow mutual use of patents between companies, while compulsory licenses are granted by governments without consent in exceptional cases.
Patent licensing
This document discusses different types of patent licensing. It defines patent licensing as granting permission to a third party to use, sell, and benefit from a patented invention in exchange for royalty payments. There are several types of patent licenses: exclusive licenses grant all rights except title to one licensee; non-exclusive licenses allow a patent owner to grant rights to multiple parties; sub-licenses are granted by licensees to third parties; and cross-licenses allow an exchange of licenses between companies. The document also discusses advantages like risk transfer and access to global markets, as well as challenges like loss of control and difficulty finding licensees.
“A STUDY ON THE GROWTH OF DERIVATIVES MARKET IN INDIA”
This document provides an overview of derivatives markets in India. It defines different types of derivatives such as options, futures, forwards, and swaps. Futures contracts and forward contracts are described as agreements to buy or sell an asset at a future date and price, with the key difference being that futures contracts are standardized and exchange-traded, while forwards are customized over-the-counter contracts. The document discusses how these derivatives can be used for hedging, speculation, and gaining exposure to different asset classes or markets.
SWOT ANALYSIS OF ARBITRATION AWARDS IN INDIAN CONSTRUCTION CONTRACTS
Contract forms, terms, specification, analysis of rate and conditions of contract
are being followed by various governments departments in the field of civil
construction are not uniform. Against the backdrop of India’s burgeoning macroeconomic prospects, the weaknesses of the construction industry create challenges,
particularly with respect to settlement of disputes between the owner and contractor
that it will have to overcome. Arbitration awards have been studied and based upon
their analyses a series of survey questionnaire have been developed. The responses to
the above along with the gist of focused discussions and interviews with domain
experts forms the basis for SWOT analyses of arbitration awards.
START-UPS: PROTECT YOUR RIGHTS IN SOFTWARE INDUSTRY
The growing IT sector and growth of Start-ups necessitated the better documentation to protect the respective rights and IPR. In India, the agreements should to be suited to the local condition with due regard to the court system and judicial response to such clauses. Any copy-paste approach may prove appalling in long term. Inadvertent drafting of payment Clauses meant for ensuring effective payment are seen to be attracting huge tax liability. Similarly blind adoption of arbitration clauses may lead to tremendous expense shoot-up making it costly deal for the Start-ups. Any casual approach can prove fatal for Star-ups in long term.
Software License An Introduction By Vishnu Kesarwani
The document discusses different types of software licenses:
1. Based on the mode of contract, licenses can be negotiable (allowing both parties to negotiate terms) or non-negotiable like shrink-wrap licenses and click-wrap licenses.
2. Based on relationships, there are developer-publisher licenses and publisher-distributor licenses.
3. Based on freedom, licenses include proprietary licenses (allowing only use) and free/open source licenses (allowing modification and redistribution).
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technology transfer documents confidentiality agreements, licensing, mous.pdf
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Alteration of Patent Protection Length in the Intellectual Property Provision...
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Technology Transfer Related Documents.pptx
- 1. Industrial Pharmacy - II TOPIC: Technology Transfer Related Documents Hon. Shri. Babanrao Pachpute Vichardhara Trust’s, Group of Institution, Faculty of Pharmacy, Kashti, Shrigonda Technology Development & Transfer UNIT 2 Presented by: Mr. Afroj Ayyaj Shaikh (final Year B. Pharm) Roll no. 74 Guided by: Prof. Gaurav Wadurkar (M. Pharm)
- 2. Documentation • Documentation is the process of communicating in written form about of essential fact or the maintenance of continuous history of event over a period of time. • The documentation needed for the technology transfer. • Some of documents associated to technology transfer are as follows 1. Confidentiality Agreement 2. Licensing 3. MOU 4. Legal Issues TECHNOLOGY TRANSFER RELATED DOCUMENTS Confidentiality Agreement Confidentiality Agreement is a secrete document and its also known as Non-disclosure agreement.
- 3. It is used to protect the proprietary nature of the technology and retain the confidentiality of a technology or invention. The drafting of appropriate clauses can be essential for the maintenance of the value of the technology. The need of this agreement is due to the increase in competition and the new technologies can be explained. Licensing Technology licensing is a contractual arrangement in which the licensor’s intellectual property (IP) such as, patent, trademark, service marks, copyrights, trade secrete or other intellectual property may be transferred to a licensee for a specified period of time.
- 4. A Technology Transfer agreement may be: A. Exclusive B. Non-Exclusive 1. Exclusive Licensing The licensing has an exclusive right to use the IP, as per the terms of the licensing agreement. This agreement is such that even the licensor is not allowed to use the licensed asset for the duration as specified by the license agreement. An exclusive license may be issued on either a territorial basis (for instance, India only) or on a global basis (for the entire world). 2. Non-Exclusive Licensing In non-exclusive licensing, the licensor may license out their assets to multiple licensees at the same
- 5. time. Unlike an exclusive license, all licensees are permitted to use the license as per the terms of the license agreement. The licensors are also free to use the assets that they licensed to others. Memorandum of Understanding(MOU) Memorandum of Understanding is Negotiated agreement and contract public sector enterprise (CPSE). MOU is an agreement between two or more parties outlined in a formal document. It is not legally binding but signals the willingness of the parties to move forward with a contract An MOU is an expression of agreement to proceed. It indicates that the parties have reached an understanding and are moving forward. Although it is not legally binding, it is a serious declaration that a contract is imminent. Although an MOU is not legally binding, it allows parties to prepare for singing a contract by explaining the broad concepts and
- 6. expectation of their agreement. Communicating in clear terms what each party hopes to gain from an agreement can be essential to the smooth execution of signing a legal contract in the future. Legal Issue The legal aspect of technology transfer has dual character. Generally, such an agreement is contract ruled by the law of contract. • Understanding of institutional framework.(Confusion between Sending Unit & Receiving Unit) • Commercial strategy and the Law. (sometimes laws was changed after period of time its affect the strategy ) • Organization and support. (Sometimes advisors are changed during technology transferring documents) • Intellectual property issue arise
- 7. Thank You…!