Study Parameters for Stability Studies
Purpose
The purpose of this Standard Operating Procedure (SOP) is to define and document the study parameters for stability studies, ensuring consistency, accuracy, and regulatory compliance throughout the testing process.
Scope
This SOP applies to all stability studies conducted on drug substances and drug products within the pharmaceutical company’s facilities.
Responsibilities
- Stability Manager: Approve the study parameters and ensure they align with regulatory guidelines and study objectives.
- Stability Technicians: Implement and document the study parameters as specified in the stability protocol.
- Quality Assurance (QA) Team: Review and approve the study parameters for accuracy and completeness.
Procedure
- Review Stability Protocol:
- Ensure the stability protocol outlines the required
study parameters and acceptance criteria.
Define Study Parameters:
Temperature and Humidity Conditions:
Sampling Plan:
Test Methods:
Acceptance Criteria:
Documentation:
Review and Approval:
Communication:
- List the physical, chemical, microbiological, and other relevant parameters to be tested.
- Specify the methods and procedures for each parameter.
- Identify the storage conditions (e.g., 25°C/60% RH, 30°C/65% RH, 40°C/75% RH).
- Define the duration for each storage condition (e.g., 1 month, 3 months, 6 months, 12 months).
- Detail the frequency and number of samples to be tested at each interval.
- Specify the procedures for sample collection and labeling.
- Describe the analytical methods to be used for each parameter.
- Ensure all methods are validated and documented.
- Define the acceptance criteria for each parameter based on regulatory guidelines and product specifications.
- Record all study parameters in the stability protocol and associated logs.
- Ensure all data is reviewed and approved by the Stability Manager and QA Team.
- Submit the defined study parameters to the Stability Manager and QA Team for review and approval.
- Make any necessary adjustments based on feedback and finalize the study parameters.
- Communicate the finalized study parameters to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.
Abbreviations Used
- QA: Quality Assurance
- RH: Relative Humidity
- SOP: Standard Operating Procedure
Documents
- Stability Protocol
- Analytical Method SOPs
- Sample Collection and Labeling Records
- Validation Reports
References
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products
- FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products
SOP Version
Version 1.0 – Effective Date: [Insert Date]