Tech Transfer Documents Handling Procedure

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

Quality Assurance : Quality Assurance designated personnel responsible for receipt checking and issuance of tech transfer documents as per respective procedure as received from RA.
Production        : Production designated personnel to review the feasibility of the process, equipment equivalency, and other product requirements related to the process.
Quality control : Quality control designated personnel to review the analysis-related tech transfer / Analytical Method Transfer documents, the feasibility of the method, and other product requirement related to Analysis.

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

Tech Transfer Documents

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

Product Name               :

Market                          :

Customer                      :

Sr. No. Documents Date of receipt Remark
1 License Details
2 List of variation to the approved dossier
3 Product Authorization
4 Registered API specification and testing procedure
5 Registered source of API and vendor approval certificate along with next due date
6 Method validation of API
7 Excipient specification and testing procedure
8 Registered finished product specification (release & shelf life) and testing procedure
9 Method validation
10 Stability study data and shelf life declaration
11 Registered manufacturing formula
12 The registered manufacturing process and process control
13 Executed BMR & BPR from the transfer site
14 Process Validation Protocol and Report
15 Packaging Instruction
16 Registered Specification and testing procedure of Packing materials
17 Punch drawing
18 Packing layout
19 Sample of Product
20 R & D feasibility Report
21 Review comments on R & D feasibility Report
22 Review of CG comments on R & D feasibility Report
23 Technical Agreement with CG
24 Technical agreement with API manufacturer
25 Product Permission from SLA

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

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

Product Name               :

Market                          :

S. No. Process Document / Process Step Dossier Site Remark


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


Reviewed By:                                                                            Checked By:                                      

Janki Singh

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