Standard Operating Procedure (SOP) for Batch Record Preparation

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide clear instructions for the preparation, review, and approval of batch records in compliance with Good Manufacturing Practices (GMP). This ensures consistent production processes and accurate record-keeping to maintain product quality and regulatory standards.

2. Scope

This SOP applies to all personnel involved in the preparation, review, approval, and issuance of batch records for products manufactured within [Name of Company/Facility].

3. Responsibility

• Production Supervisor: Responsible for initial batch record preparation based on Master Batch Records.
• Quality Assurance (QA) Officer: Responsible for reviewing and approving batch records.
• Production Manager: Ensures adherence to batch record procedures and GMP compliance.
• QA Manager: Monitors the batch record process and conducts audits to ensure continuous improvement.

4. Definitions

• Batch Record: A document containing the history of the manufacturing process and quality control of a specific batch, from raw materials to finished product.
• Master Batch Record (MBR): A template document that provides instructions for the production of batches with standardized information and processes.
• Good Manufacturing Practices (GMP): Guidelines to ensure that products are consistently produced and controlled according to quality standards.

5. Materials and Equipment Required

• Templates: Master Batch Record (MBR) template.
• Computer and Printer: For electronic preparation of batch records.
• Controlled Document Labels: For labeling batch records as controlled documents.
• Archival Storage Materials: For storing approved batch records.

6. Procedure

6.1 Master Batch Record (MBR) Preparation

1. Identify Product Specifications: Gather all relevant information from the product specifications, manufacturing instructions, and quality control data.
2. Outline Step-by-Step Procedures: Detail all steps in the production process, including material dispensing, mixing, packaging, and labeling, in a sequential manner.
3. Include Critical Parameters: Define critical process parameters, acceptance criteria, and quality control tests at each stage.
4. Review and Approval: Submit the MBR to the Quality Assurance (QA) department for review and approval.

6.2 Batch Record Drafting

1. Start with MBR Template: Begin the batch record preparation using the approved MBR template.
2. Input Batch-Specific Information: Add batch-specific information such as batch number, production date, equipment ID, and operator details.
3. Document Each Step: Record each step of the production process, including times, quantities, and personnel involved.
4. Attach Raw Material Details: Include details of raw materials used, including their lot numbers, quantities, and supplier information.
5. Signatures and Dates: Ensure that each stage of the process is signed and dated by responsible personnel.

6.3 Review and Verification

1. Self-Review by Production Staff: Production staff should conduct an initial review of the batch record to check for completeness, accuracy, and legibility.
2. QA Verification: Submit the batch record to the Quality Assurance (QA) team for verification. QA checks for:
   • Completeness and accuracy of entries.
   • Proper documentation of deviations, if any.
   • Adherence to standard operating parameters.
3. Resolution of Discrepancies: If discrepancies are identified, they should be resolved and documented before QA approval.

6.4 Approval and Finalization

1. Final QA Approval: Once verified, the QA Manager or designated officer provides final approval by signing and dating the batch record.
2. Archival Storage: The approved batch record is archived according to company retention policies and stored in a controlled environment to prevent loss or damage.

6.5 Issuance of Batch Records

1. Control of Blank Batch Records: Ensure blank batch records are controlled and issued only as per approved requests.
2. Track Issuance Log: Maintain a log of issued batch records, including details such as batch number, issue date, and responsible personnel.
3. Document Retrieval for Review: Batch records should be readily available for retrieval during audits, quality reviews, and regulatory inspections.

7. Handling Deviations

• Record Deviations: Any deviation from standard procedures must be documented in the batch record, detailing the nature of the deviation, corrective actions taken, and approvals obtained.
• Deviations Review: QA should assess each deviation to determine its impact on the batch quality and safety. Only batches that meet acceptance criteria should proceed to the next stage of production.

8. Documentation and Retention

• Document Format: Batch records should be recorded in ink and should not have any blank fields. Any corrections should be made by striking through the original entry, initialing, dating, and adding the correct entry.
• Retention Period: Store completed batch records for a period defined by company policy or regulatory requirements, whichever is longer.

9. Training

• Training of Personnel: All personnel involved in batch record preparation, review, and approval should undergo training on this SOP.
• Frequency: Training should be conducted for new hires and periodically for all staff involved in batch records.

10. References

• Current Good Manufacturing Practices (cGMP) – [Reference relevant sections]
• Company Documentation Guidelines – [Reference internal document guidelines]

11. Revision History

• Version Number: [Version Number]
• Effective Date: [Effective Date]
• Description of Changes: [Brief Description of any changes or updates to the SOP]

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