SOP on Technology Transfer of Drug Product (Example)

In short: Technology transfer moves a product, its process and its analytical methods from a sending unit (R&D or another site) to a receiving unit (a manufacturing site) in a planned, documented way. This example SOP shows who does what, which documents must be checked, and how the first commercial batches are controlled. Adapt it to your own quality system.

About this example SOP

This is an illustrative template for QA, production, QC and packaging teams. It follows the principles of the WHO guidelines on technology transfer in pharmaceutical manufacturing and ICH Q10, but the batch counts, forms and sign-off levels shown are example in-house criterion values that each company should set for itself. See also Quality Risk Management in the pharmaceutical industry, SOP for Risk Management and Change Control.

1.0 Purpose

To define the procedure for a successful transfer of a drug product and its technology:

• from one manufacturing site to another site of the same group or company, or
• from Formulation Development (FDD) / R&D to a manufacturing site.

2.0 Scope

This SOP applies to:

• existing products transferred from one site to another, and
• new products received from FDD.

3.0 Reference documents

• Company SOP for Quality Risk Management
• Company SOP for the Stability Programme
• Company procedure for Analytical Method Transfer
• Company Change Control procedure
• WHO Technical Report Series No. 1044 (2022), Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing
• ICH Q10, Pharmaceutical Quality System, section 3.1.2 (Technology Transfer)

4.0 Responsibilities

5.0 Definitions

Technology transfer is a logical, documented procedure for passing the knowledge and experience of a product, process or analytical method from a sending unit to a receiving unit so that the receiving unit can consistently reproduce it against agreed specifications (WHO TRS 1044, Annex 4).

Master Product Specification (MPS) is the core information package for a product. It typically contains:

• ERP codes for API, excipients and primary packing materials, and their sourcing;
• detailed manufacturing formula and bill of materials;
• precautions for handling, storage and sampling;
• a brief manufacturing process and the critical equipment and process requirements;
• required utilities and consumables;
• tooling and change-part details (size, shape, drawings);
• primary packing material specifications;
• in-process and finished product specifications;
• stability data, safety data sheets, draft label and process flow chart.

6.0 Procedure

6.1 Receiving and reviewing the transfer package

1. The FDD, ADD or transferring site sends all documents for the new or transferred product to the site.
2. Site QA tells the sender about any additional document needed and confirms it is provided.
3. On receipt, QA enters the details in the new/transferred product checklist (Annexure 1) and issues it to all involved departments.
4. Each department checks the documents for its own area, completes the checklist and returns it to QA. QA may complete the checklist in consultation with department heads.
5. QA reviews whether the documents are complete and available. Any analytical method precautions are communicated by ADD to site QC.

A gap analysis between the sending and receiving units (personnel, premises, equipment, utilities, cleaning, quality control, documentation and validation status) is part of good practice under WHO TRS 1044, Annex 4, section 4. Differences found should be assessed with quality risk management and handled through change control.

6.2 Materials, tooling and change parts

1. The warehouse raises purchase requests for raw and packing materials.
2. For tablets, production specifies tablet size, shape, quantity and type of tooling for the available press, and records any special tooling features given by FDD (for example, a keyed lower punch or hard-chrome plating) in the MPS.
3. Production orders capsule change parts, and packing orders packing change parts, to the size and requirement given in the MPS.
4. When materials, change parts, tooling and the required regulatory permissions (for example, the manufacturing licence or product permission applicable to your site) are in place, FDD is informed so it can support setting the manufacturing parameters.

6.3 Documents before the first batch

Before the manufacturing plan is released, prepare and approve:

• manufacturing BOM and master BMR,
• packing BOM and master BPR,
• specifications and analytical test procedures for all materials and the product,
• the risk assessment report, with its mitigation plan reviewed by QA.

Confirm that raw and packing materials are available before the plan is finalised, and complete the New Product Manufacturing Authorisation (Annexure 2).

6.4 First batches at the site

1. If needed, the first batch is made in the presence of FDD or transferring-site production personnel, so the site learns the critical steps and precautions.
2. If the first batches show that changes are needed, FDD revises the MPS and the master BMR/BPR are updated through change control.
3. IPQA withdraws stability samples, and the stability study runs under the site Stability Programme SOP.
4. For the first three commercial batches (example in-house criterion), the packing officer completes the New Product Packing Inspection Report (Annexure 3) and IPQA cross-verifies it. At least five packed shippers are checked per batch during packing (example in-house criterion).
5. After the BPR is closed, QA completes the batch release authorisation for each of the first three commercial batches (example in-house criterion).
6. Process validation, cleaning validation and analytical method transfer are completed as required by the site validation plan. See Process validation.

Records of the transfer (checklists, risk assessments, batch records, reports) are kept at least 1 year after the expiry date of the respective product batch (EU GMP Part I, Chapter 4, section 4.11; 21 CFR 211.180(a)), longer if local law or the marketing authorisation requires.

7.0 Abbreviations

8.0 Annexures

Annexure 1 – Checklist for new / transferred product

Departments tick each document or item they have checked for their area, with comments and sign-off by QA.

Annexure 2 – New Product Manufacturing Authorisation

For a commercial product

Based on the available data, the product is authorised for manufacture subject to the above criteria being met.

Annexure 3 – New Product Packing Inspection Report

The packing officer records the packing checks for each of the first three commercial batches, and IPQA cross-verifies them.

Frequently asked questions

What is the difference between a sending unit and a receiving unit?

The sending unit (SU) is the site or department the product comes from, such as R&D or another plant. The receiving unit (RU) is the site that must learn to make and test it. WHO TRS 1044, Annex 4 uses these terms.

Does technology transfer need regulatory approval?

Moving a product to a new site generally needs the relevant regulatory permission or variation before commercial supply. Check with your Regulatory Affairs team and the licensing authority that applies to you.

How many batches are needed at the new site?

No fixed number is given in the WHO guideline. The three-batch pattern in this example SOP is an example in-house criterion. Your validation plan and risk assessment decide what is needed.

Where does ICH Q10 fit in?

ICH Q10 section 3.1.2 says technology transfer should pass product and process knowledge from development to manufacturing, and between sites, to form the basis for the manufacturing process, control strategy and process validation approach.

References

1. World Health Organization. WHO guidelines on technology transfer in pharmaceutical manufacturing. WHO Technical Report Series No. 1044, 2022, Annex 4.
2. ICH Q10, Pharmaceutical Quality System (Step 4, June 2008), section 3.1.2 Technology Transfer.
3. European Commission. EudraLex Volume 4, EU GMP Part I, Chapter 4: Documentation, section 4.11.
4. US FDA. 21 CFR 211.180(a), General requirements (record retention).