Technology Transfer Related Documents.pptx

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.

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 Confidentiality Agreement Licensing MOU 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: Exclusive Non-Exclusive Exclusive Licensing T he 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). 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 p er 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 a fter 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…!