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Standard Operating Procedure for the handling of Tech Transfer documents received from transferring unit (TU)/ generated at receiving unit (RU) during tech transfer activity.

Tech Transfer Documents

1.0   Objective

• • To lay down the procedure for Handling Tech transfer documents for the products to be introduced/transferred at the site.

2.0   Scope

• • This SOP is applicable to all Technology transfer (Tech Transfer) Documents for products to be transferred to the site.

3.0   Responsibility

4.0   Procedure – Handling of Tech Transfer Documents

• • Receipt of Tech Transfer Documents

  • All documents related to technology transfer shall be received by QA as hard copy or by e-mail communication.

• • After receipt of documents designated QA personnel shall check as per Annexure-II, (the contents defined are not limited to) and identify the pending document, and details of the pending document shall be communicated to RA.

• • In case any document is not received from CG, the reason for not availability of the document shall be written under the remark column.

• • QA shall check the completeness of the document and put the stamp of “Receipt By” on the first page of each document as per SOP “Document and Data control”.

• • The receipt date shall be mentioned on the checklist accordingly.

• • Any discrepancies related to receiving shall be shared with RA for clarification.

• • All CG Documents should be kept in one file including all correspondence for ease of review.

• • Flow chart shall be followed (Annexure-I).

• • Review of Tech Transfer Documents

  • The only document having a Receipt stamp shall be issued further to the respective Department.

• • QA shall issue the reference copy of QC-related documents (e.g. Analytical method, specifications, and testing procedure of API, intermediate and finished product) and Production related Documents (e.g. Master formula, manufacturing process, Critical process parameter, equipment equivalency, etc).

• • Issuance of documents to respective departments shall be done as per respective SOP.

• • Department shall review the documents and summarize the gaps if any.

• • Tech Transfer Document review shall be done as per template Annexure-III of SOP, template shall be used for individual document and all identified gaps can be summarized.

• • Document review preferably completed within 07 days after the date of issuance and delay shall be justified by the concerned department.

• • The functional head shall review all CG documents related to the department.

• • The Gaps identified for sharing with CG shall be summarized in Annexure-III and a signed copy shall be submitted to QA.

• • Review comments received from the department shall be reviewed by the Technical Committee (QA, QC, Production, and Site Head) and the outcome of the committee review shall be shared with RA with respect to the feasibility of the manufacturing and testing process.

• • After finalization of the project required draft documents shall be prepared by the respective department.

• • The document received from R&D like the feasibility report, R&D trial report shall be received and shall be enclosed with the product file.

• • Received comment of contract Giver (CG) on R&D report also be reviewed by QA and CG comment shall be discussed with the technical team.

• • After finalization of product and getting the clearance to go ahead, the respective department shall initiate the activities like –

• • • Preparation of specifications,

• • • Testing procedures,

• • • Batch manufacturing record,

• • • Batch Packing Record,

• • • Process validation Protocol,

• • • Method validation protocol,

• • • Hold time protocol,

• • • Cleaning assessment and

• • • Other documents as per requirement by Contract giver (CG) meeting the requirement.

5.0   Annexures – Tech Transfer Documents

Annexure – I – Handling of Technology transfer Documents Flow Chart

Annexure-II – Index of Documents Required for Technology Transfer Products

Product Name               :

Market                          :

Customer                      :

Annexure- III – Documents Review comments on Technology Transfer Products.

Documents Review comments on Technology Transfer Products…………………………………………(Document Name)

Product Name               :

Market                          :

Remark: ………………………………………………………………………………………………………………………..

Reviewed By:                                                                            Checked By: