Procedure for Documentation of Packed Batches
| Department | Packaging/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/099 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the procedure for documenting packed batches of ointments. This ensures proper batch traceability, regulatory compliance, and adherence to Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for recording, verifying, and maintaining documentation for packed batches.
3. Responsibilities
- Packaging Operator: Records packaging details in the Batch Packaging Record (BPR).
- Packaging Supervisor: Reviews batch documentation for completeness and accuracy.
- Quality Assurance (QA) Officer: Verifies documentation and approves batch records.
- QA Manager: Ensures all documentation complies with regulatory and GMP standards.
4. Accountability
The QA and Packaging Managers are accountable for maintaining accurate records of packed batches before final product release.
5. Procedure
5.1 Pre-Packaging Documentation
- Ensure that the Batch Packaging Record (BPR) is available before starting the packaging process.
- Verify that batch numbers, expiry dates, and packaging materials match the approved specifications.
- Confirm that line clearance has been performed and documented.
5.2 In-Process Documentation
- Record packaging line operations, including batch start and end times.
- Document equipment settings, packaging material usage, and process parameters.
- Ensure
that packaging defects and corrective actions are recorded.
5.3 Post-Packaging Documentation
- Complete the final batch reconciliation, ensuring the correct quantity of packed units.
- Record the disposal of excess or rejected packaging materials.
- QA must verify and sign off on completed batch documentation.
5.4 Storage and Record Retention
- Store batch records in a secure, designated area for regulatory inspections.
- Ensure records are maintained for the required retention period as per regulatory guidelines.
- Provide documentation access to authorized personnel only.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BPR – Batch Packaging Record
7. Documents
- Batch Packaging Record (Annexure-1)
- Final Batch Documentation Approval Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q10 – Pharmaceutical Quality System
- USP <41> – Weights and Balances
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Packaging Record
| Date | Batch Number | Packaging Material Used | Operator Name | Reviewed By | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Cartons, Tubes, Labels | Packaging Operator | QA Officer | Compliant |
| 01/02/2025 | OINT-102 | Cartons, Seals | Packaging Operator | QA Officer | Compliant |
Annexure-2: Final Batch Documentation Approval Report
| Date | Batch Number | Document Type | Verified By | Approval Status |
|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Batch Packaging Record | QA Manager | Approved |
| 02/02/2025 | OINT-102 | Batch Packaging Record | QA Manager | Approved |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |