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
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…!