TECHNOLOGY TRANSFER PROCESS IN PHARMACEUTICAL INDUSTRY: AN OVERVIEW

 

Technology Transfer Procedure:
1.     
Procedure for Manufacturing and Packaging:
*  After the completion of three validation/commercial batches, R&D shall prepare the technology transfer dossier (TTD), which shall be reviewed by Head- Production, Head-QC, Head- Engineering and approved by Head-QA.
*  The dossier shall contain the details of unitary formula, process flow chart, raw material and packing material specifications, in-process and finished product specifications, master formula card, safety parameters, critical process steps, critical process parameters and their specifications and measured response, process validation protocol, process validation report, stability data, deviation and change controls, product development report.
*  After successful transfer of technology (manufacturing process), manufacturing of the respective product is the responsibility of production department. If any problem arises, QA shall investigate and refer to R&D through investigation report in the form of Inter Office Communication (IOC).
*  Any deviation in the process shall be supported by deviation/change control form as applicable.
*  For third party and loan license products, respective organization will provide the TTD to QA and manufacturing process shall be demonstrated to production personnel on minimum of two or three batches. 

2.      Procedure for Analytical Method Transfer:
a.     
For Drug Product:
*  Analytical method transfer shall be initiated by analytical department for all the validated methods.
*  Analytical department analyst along with quality control analyst has to perform analysis as per the analytical method transfer protocol.
*  The transfer activity shall be established on the optimization batch or process batch with the final formula.
*  Analytical method transfer activity shall be initiated with analytical method transfer protocol prepared by AR&D, reviewed by DQA/QC and finally approved by QA.
*  The analytical method transfer protocol shall explain the transfer activities of the drug product and also the parameters that shall be transferred are Assay, Dissolution, Related substances, Content uniformity and Residual solvents.
*  In case of multiple strengths, analytical method transfer shall be performed for lower strength.
*  All chromatograms, record of results and other information have to be interlinked and records have to be maintained.
*  A report has to made with summarized results and conclusions and the same shall be reviewed by Head-DQA and Head-QC, approved by Head-QA.
*  The analytical method transfer process is considered to be completed upon the certification by analytical department, quality control & quality assurance that the method under consideration meets the acceptance criteria.
*  Finally analytical method transfer report shall be prepared.

b.      For Drug Substances:
·         Non Pharmacopoeial Methods:
The vendor has to transfer the analytical methods to QC. In case, if the analytical method transfer activity was not performed by the vendor the same shall be prepared by AR&D as per the STP.
·         Pharmacopoeial Methods:
The vendor has to transfer the analytical methods to QC. If the methods are same as per respective pharmacopoeia, the method suitability shall be performed by AR&D. Suitability of the analytical method shall verified by performing the specificity (RRT verification) and precision study (Triplicate) and the same shall be reviewed by DQA and communicated to QC.
*  Analytical method transfer protocol and report shall be prepared.
*  The analytical method transfer protocol shall explain the transfer activities of the drug substance and also the parameters that shall transferred are assay, residual solvents, related substances,.
*  All chromatograms, record of results and other information have to be interlinked and records have to be maintained.
*  A drug substance analytical method transfer report has to be made with summarized results with conclusions as per drug product method transfer report.
*  The limits and parameters described for drug product/drug substance are indicative, but shall altered based on customer’s requirements and nature of drug product/drug substances to be followed as per respective analytical method transfer protocol.
*  Documentation for analytical method transfer activity shall be done by analytical R&D department.

The Technology Transfer Report:
Regulatory inspectors and sometimes assessors will ask for evidence of successful transfer. This is more likely when the technology being transferred, be it the process or analytical method, is new to the site or poses particular challenges e.g. the introduction of bioassays. The report should also serve a similar function to the original development pharmaceutics report in that it provides a "ready reckoner" of key aspects of the product and a reference point in the future if problems are encountered.

Discussion:
The process of technology transfer is considered to be completed after successful completion of three validation batches by demonstration of the manufacturing process by R&D personnel to production personnel. Ensure that the development team reliably transfer all relevant quality, technical information to the receiving site such that the process must operate consistently and the critical process parameters are well defined and understood by the production personnel.

Conclusion:
Appropriate technology transfer is important to upgrade the quality of design to be the quality of product, and ensure stable and high quality of the product. The technology transfer does not mean one-time actions taken by the transferring party toward the transferred party, but means continuous information exchange between the both parties to maintain the product manufacturing.

Acknowledgement:
Authors wish to give thanks to Natco Pharma Ltd., Hyderabad for constant support and given literature to carry out this review.

References:
1. Analytical Procedures Technology Transfer. ISPE Draft Guidelines. International Society of Pharmaceutical Engineers, ISPE European Office, 7 Avenue des Gaulois, 1040 Brussels, Belgium.
2. Draft Guidelines for Validation of Analytical Procedures. International Committee for Harmonization (ICH).
3. Guideline for Technology Transfer (Draft), Cited 2009 December 12. Available from:
URL: nihs.go.jp/drug/GMP/04BDH0149-1post.pdf
4. Technology Transfer from R & D to production, Cited 2010 February 6.
Available from URL: bioqc.org/workshopdata/1Technology.pdf
5. Singh Amanjeet, Aggarwal Geeta. Technology Transfer In Pharmaceutical Industry: A Discussion. International Journal of Pharma and Bio Sciences. July-September 2009;           1, Issue-3.
6. YUE Feifei and YUE Yingming. Research on Technology Transfer in the Pharmaceutical Industry. Available from: 2010cygchy01a3.pdf

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