Standard Operating Procedure for Batch Record Keeping

Purpose

The purpose of this SOP is to establish procedures for the accurate and systematic documentation of batch records, ensuring traceability, compliance with regulatory standards, and maintaining a comprehensive record of each pharmaceutical product batch.

Scope

This SOP applies to all personnel involved in the batch record keeping process, including operators, quality control personnel, and documentation specialists.

Responsibilities

• Operators: Responsible for documenting key operational steps and observations during the manufacturing process.
• Quality Control Personnel: Responsible for reviewing and approving batch records for accuracy and compliance with specifications.
• Documentation Specialists: Responsible for organizing, maintaining, and archiving batch records in accordance with established procedures.

Procedure

1. Start the batch record at the beginning of the manufacturing process.
2. Record all critical information, including batch number, date, product details, and equipment used.
3. Document each step of the manufacturing process, including raw material dispensing, mixing, filling, and any other relevant activities.
4. Record actual values and observations, ensuring accuracy and completeness of the information.
5. Include details of any deviations or unexpected events encountered during the manufacturing process.
6. Obtain necessary approvals from designated personnel at key stages of the process.
7. Document in-process quality control checks and test results, including any adjustments made based on these results.
8. Ensure that all required signatures and approvals are obtained for each section