Documentation in technology
transfer
Manish Shankarpure
M.Pharm 1st year
Alard college of Pharmacy
Guided by
Prof.Mane sir
Content
Technology Transfer Documentation :
1. Organization for Technology Transfer
2. Product Specification
3. Technology Transfer Plan
4. Research and Development Report
5. Manufacturing Related Documents Including Drug Product
Standards
6. Verification of Results of Technology Transfer
Documentation of Technology Transfer
Technology Transfer Documentation :
• It includes the documentation of efficient running of technology transfer within the parties of the
group. Technology transfer documentation are generally interpreted as documents indicating
contents of technology transfer for transferring and transferred parties. The raw data of the
documents (such as development report) should be prepared and compiled according to
purposes, and should be always readily available and traceable.
• Quality assurance department should established conformation process for all kinds of
technology transfer documentation, and should check and approve the documentation.
Technology transfer documentation are indicated as follows:
Organization for Technology Transfer:
• One of the most significant elements for successful technology transfer is closed
communication between transferring and transferred parties.
• Therefore, organization for technology transfer should be established and composed of
both party members, roles, scope of responsibilities of each party should be clarified and
adequate communication, and feedback of information should be ensured.
• It is desirable that this organization complies with GMP.
Product Specification : The manufacturing data with evaluation of the manufactured product
with their specification should be mentioned in that method of product specification. The
product specification file should contain the following:
• Information necessary for the start and continuation of product manufacturing.
• Information necessary for quality assurance of the product.
• Information necessary for assurance of operation safety.
• Information necessary for environmental impact assessment.
• Information of costs.
Technology Transfer Plan:
The technology transfer plan is to describe items and contents of technology to be transferred and
detailed procedures of individual transfer and transfer schedule, and establish judgment criteria for
the completion of the transfer.
Research and Development Report:
• To realize quality assurance at all stages from drug development to manufacturing, transfer to
manufacturing, transfer of technical documents concerning product development or
corresponding documents should be considered.
• The research and development report (development report) is a file of technical development,
and the research and development department is in charge of its documentation.
• Informations to be contained in the development report are:
1. Raw materials and components.
2. Synthetic route.
3. Rational for dosage form & formula designs and design of manufacturing methods.
4. Rational and change histories of important processes and control parameters.
5. Quality Profiles of manufacturing batches ( including stability data).
6. Specifications and test methods of drug substances, intermediates, drug products, raw
materials, and components, and their rationale
Verification of Results of Technology Transfer :
After the completion of technology transfer and before the start of manufacturing of the product, the
transferring party should verify with appropriate methods such as product testing and audit that the
product manufactured after the technology transfer meets the predetermined quality, and should
maintain records of the results.
Manufacturing Related Documents Including Drug Product Standards :
The transferred party should compile documents such as drug product standards necessary for
manufacturing, various standards and validation plans/reports after the completion of technology
transfer. While the transferred party is responsible for compiling these documents, the transferring
party should make necessary confirmation for these documents.
Referances
• Technology Transfer: A Paradigm for Industry Swapnil Nivrutti Misar1 *, Akshaykumar Vinodrao
Bhurghate2 , Jitendra Singh Sisodia2 , Somnath Kailas Gaikwad3 and Hitendra Brijlal Patil
Swapnil N. Misar et al Int. J. Pure App. Biosci. 2 (2): 221-228 (2014)
• International Journal of Advances in Pharmaceutics E-ISSN: 2320-4923; P-ISSN: 2320-4931 Popat
B. Mohite* and Sachin V. Sangle
