Guidelines for Stability Testing of ATMPs as per EMA Guidelines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for Advanced Therapy Medicinal Products (ATMPs) in accordance with European Medicines Agency (EMA) guidelines. This SOP ensures that stability data supports the quality, safety, and efficacy of ATMPs throughout their shelf life.
2) Scope
This SOP applies to all personnel involved in the design, execution, and documentation of stability studies for ATMPs intended for the European market.
3) Responsibilities
Stability Testing Team: Responsible for conducting stability studies and documenting results in compliance with EMA guidelines.
Quality Assurance (QA) Team: Responsible for reviewing and approving stability study protocols and reports.
Regulatory Affairs Team: Responsible for ensuring that stability studies meet EMA regulatory expectations for ATMPs.
4) Procedure
4.1 Preparation for Stability Testing
4.1.1 Obtain and review the latest EMA
4.1.2 Develop a stability protocol specific to ATMPs, including study design, testing schedule, storage conditions, and testing parameters as per EMA guidelines.
4.2 Selection of Batches and Samples
4.2.1 Select representative batches of the ATMP, typically three primary batches manufactured using the proposed production process.
4.2.2 Prepare sufficient samples to
4.3 Defining Storage Conditions and Time Points
4.3.1 Define the storage conditions according to EMA guidelines, which may include cold chain or cryogenic storage depending on the product type.
4.3.2 Establish the time points for sampling, such as 0, 3, 6, 9, 12, 18, and 24 months for long-term studies, and additional time points for accelerated studies.
4.4 Conducting Stability Tests
4.4.1 Store samples under the defined conditions, ensuring the cold chain or other specific storage requirements are maintained.
4.4.2 At each specified time point, remove samples and conduct stability-indicating tests, including potency, purity, and functional assays relevant to the ATMP, as applicable.
4.4.3 Record all results meticulously in stability data sheets, ensuring accuracy and traceability of data.
5) Abbreviations, if any
EMA: European Medicines Agency
ATMPs: Advanced Therapy Medicinal Products
QA: Quality Assurance
6) Documents, if any
Stability protocol, stability data sheets, stability testing records, stability report, submission package to EMA.
7) Reference, if any
EMA Guidelines on Stability Testing of Advanced Therapy Medicinal Products (ATMPs).
8) SOP Version
Version 1.0