The Initial Certificate of Analysis at T-Zero for a Stability Study

Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for generating the initial Certificate of Analysis (CoA) at time zero (T0) for a stability study to ensure accurate and comprehensive documentation of the initial condition of the drug substance or product.

Scope

This SOP applies to all stability studies conducted on drug substances and drug products within the pharmaceutical company’s facilities, specifically focusing on the generation and documentation of the T0 Certificate of Analysis.

Responsibilities

• Stability Manager: Approve the initial CoA and ensure it aligns with regulatory requirements and study protocols.
• Analytical Chemists: Conduct the initial testing and generate the CoA for T0.
• Quality Assurance (QA) Team: Review and approve the initial CoA for accuracy and completeness.

Procedure

1. Review Stability Protocol:
   • Ensure the stability protocol specifies the tests and acceptance criteria for the initial analysis at T0.
2. Sample Collection:
   • Collect samples from the designated batch(es) according to the protocol.
   • Ensure samples are labeled and documented properly.
3. Conduct Initial Testing:
   • Perform all specified tests on the collected samples according to validated analytical methods.
   • Record all raw data and observations during testing.
4. Generate Certificate of Analysis:
   • Compile the results of the initial tests into a Certificate of Analysis.
   • Include the following information in the CoA:
     • Product name and batch number
     • Testing parameters and methods used
     • Results for each test
     • Acceptance criteria
     • Date of testing
     • Signature of the responsible analyst
5. Review and Approval:
   • Submit the CoA to the QA Team for review and approval.
   • Ensure the CoA is signed and dated by the QA representative.
6. Documentation:
   • Store the approved CoA in the stability study file and any relevant databases.
   • Ensure that copies of the CoA are available for regulatory inspections and internal audits.
7. Communication:
   • Distribute the approved CoA to relevant stakeholders, including the Stability Manager and project team.

Abbreviations Used

• CoA: Certificate of Analysis
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• T0: Time Zero

Documents

• Stability Protocol
• Analytical Method SOPs
• Sample Collection and Labeling Records
• Initial Testing Raw Data

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]