Standard Operating Procedure for Stability Study Sampling Plan Development
Purpose
The purpose of this SOP is to establish procedures for the development of a sampling plan for stability studies conducted in the pharmaceutical industry.
Scope
This SOP applies to all personnel involved in the planning and execution of stability studies for pharmaceutical products.
Responsibilities
- Quality Assurance: Responsible for oversight and approval of the stability study sampling plan.
- Formulation and Development: Responsible for providing information on critical product attributes and factors affecting stability.
- Regulatory Affairs: Responsible for ensuring that the sampling plan complies with regulatory requirements.
Procedure
- Review the stability study protocol to identify the specific requirements for sample collection and testing.
- Collaborate with the Formulation and Development team to understand critical product attributes and potential degradation pathways.
- Consider factors such as dosage form, packaging, storage conditions, and regulatory guidelines when developing the sampling plan.
- Define the frequency and time points for sample collection based on the expected stability profile of the product.
- Specify the number of samples to be collected at each time point, considering statistical and scientific principles.
- Document the sampling plan in a detailed protocol, including rationale, acceptance criteria, and any deviations from standard procedures.
- Obtain approval from the Quality Assurance department before implementing the sampling plan in the stability study.
- Regularly review and update the sampling plan as needed, considering ongoing stability data and any changes in product formulation or manufacturing processes.
Abbreviations
No abbreviations are used in this SOP.
Documents
- Stability Study Protocol
- Sampling Plan Development Protocol
- Approved Sampling Plan
Reference
ICH Q1A (R2) – Stability Testing of New Drug Substances and Products
SOP Version
Version 1.0