SOP for Defining Parameters for Stability Testing

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

  1. Review Stability Protocol:
    • Ensure the stability protocol outlines the required study parameters and acceptance criteria.
  2. Define Study Parameters:
    • List the physical, chemical, microbiological, and other relevant parameters to be tested.
    • Specify the methods and procedures for each parameter.
  3. Temperature and Humidity Conditions:
    • 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).
  4. Sampling Plan:
    • Detail the frequency and number of samples to be tested at each interval.
    • Specify the procedures for sample collection and labeling.
  5. Test Methods:
    • Describe the analytical methods to be used for each parameter.
    • Ensure all methods are validated and documented.
  6. Acceptance Criteria:
    • Define the acceptance criteria for each parameter based on regulatory guidelines and product specifications.
  7. Documentation:
    • 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.
  8. Review and Approval:
    • 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.
  9. Communication:
    • Communicate the finalized study parameters to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.
See also  Advances in Stability Testing Methodologies

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]

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