Guidelines for Stability Testing of Modified Release Products
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide a procedure for conducting stability studies of modified release drug products in accordance with US FDA and ICH guidelines. This SOP ensures that the stability data generated is suitable for supporting product quality, safety, and efficacy throughout its shelf life.
2) Scope
This SOP applies to all personnel involved in the design, execution, and documentation of stability studies for modified release products intended for global markets.
3) Responsibilities
Stability Testing Team: Responsible
Quality Assurance (QA) Team: Responsible for reviewing and approving stability protocols and reports, ensuring compliance with regulatory requirements.
Regulatory Affairs Team: Responsible for ensuring the study design and results
4) Procedure
4.1 Preparation for Stability Testing
4.1.1 Obtain and review the latest versions of the US FDA and ICH guidelines for stability testing of modified release products.
4.1.2 Identify the modified release product to be tested and determine the type of stability study required (e.g., long-term, accelerated, intermediate).
4.1.3 Develop a stability protocol that includes study design, testing schedule, storage conditions, and testing parameters as per FDA and ICH guidelines.
4.2 Selection of Batches and Samples
4.2.1 Select representative batches of the modified release product, typically three primary batches manufactured using the proposed production process.
4.2.2 Prepare sufficient samples to cover the entire study duration, considering the number of time points and tests to be conducted.
4.3 Defining Storage Conditions and Time Points
4.3.1 Define the storage conditions as per regulatory guidelines, typically including:
- Long-term stability: 25°C ± 2°C/60% RH ± 5% RH
- Accelerated stability: 40°C ± 2°C/75% RH ± 5% RH
- Intermediate stability (if needed): 30°C ± 2°C/65% RH ± 5% RH
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 or intermediate studies.
4.4 Conducting the Stability Tests
4.4.1 Store samples under the defined conditions, monitoring temperature and humidity to ensure compliance with the set parameters.
4.4.2 At each specified time point, remove samples and conduct stability-indicating tests, including physical, chemical, and dissolution tests, as applicable.
4.4.3 Record all results meticulously in stability data sheets, ensuring accuracy and traceability of data.
5) Abbreviations, if any
US FDA: United States Food and Drug Administration
ICH: International Council for Harmonisation
QA: Quality Assurance
6) Documents, if any
Stability protocol, stability data sheets, stability testing records, stability report, submission package to regulatory authorities.
7) Reference, if any
US FDA Guidance for Industry: Stability Testing of Modified Release Products, ICH Guidelines.
8) SOP Version
Version 1.0