Question Received:
If a routine commercial product with a proven 5-year shelf life is transferred to another manufacturing site in Europe, can we reduce the stability testing — for example, test fewer batches or skip quarterly testing in the first year?
Answer:
Yes, it can be optimized, but only when supported by strong scientific and risk-based justification. Regulatory flexibility exists, provided product comparability and prior stability performance are well established.
Regulatory basis:
Guidelines such as ICH Q1A(R2) (Stability Testing), EMA Guideline on Variations (Rev. 2), and ICH Q9/Q10 (Quality Risk Management and Pharmaceutical Quality System) allow reduced testing frequency when supported by prior knowledge and risk assessment. The WHO Technology Transfer Guideline (TRS 961 Annex 7) also supports a risk-based approach to site transfer.
Key principle:
The primary requirement is to demonstrate that the site transfer does not introduce any new risks to product stability. If the formulation, process, equipment, packaging, and climatic zone remain the same, the transfer can be considered low-risk.
Practical approach:
Reduce validation batches: Instead of three, two commercial-scale batches may suffice if analytical and process comparability is proven.
Optimize stability schedule: Rather than quarterly testing in the first year (0, 3, 6, 9, 12 months), testing at 0, 6, and 12 months may be acceptable when justified by existing 5-year stability data.
Use bridging stability: Demonstrate that new site batches show similar stability trends to the old site at key intervals.
Include lifecycle monitoring: Continue long-term testing post-approval to maintain assurance throughout the product’s shelf life.
Regulatory submission tips:
Provide a structured justification including:
- A clear risk assessment (ICH Q9).
- Evidence of process and analytical comparability.
- A proposed stability protocol based on prior data.
- A commitment for ongoing stability monitoring if required.
In summary:
For a well-established, stable product, a reduced stability program during site transfer is scientifically acceptable and regulatory-compliant when the risk is minimal and supported by robust data. This approach aligns with the ICH philosophy of science-based, risk-based decision-making and helps streamline post-approval variations without compromising product quality.
Read also:
- Different Types of Stability Studies in Pharmaceutical Industry
- Stability Requirements for Oral Solid Formulations in ANDA
- WHO Guideline on Technology Transfer in Pharmaceutical Manufacturing
Resource Person: Moinuddin Syed. Ph.D, PMP®
