Procedure for Maintaining Traceability of Dispensed Materials
| Department | Production/Quality Assurance |
|---|---|
| SOP No. | SOP/Ointment/006 |
| 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 establish a system for maintaining the traceability of dispensed materials used in ointment manufacturing. This ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality control standards.
2. Scope
This SOP applies to all dispensed raw materials, including active pharmaceutical ingredients (APIs) and excipients, used in the production of ointments. It covers documentation, tracking, storage, and reconciliation of materials.
3. Responsibilities
- Production Operator: Responsible for recording the details of dispensed materials.
- Quality Control (QC) Personnel: Verify traceability data and ensure compliance.
- Production Supervisor: Ensure all records are updated in real-time.
- Quality Assurance (QA) Officer: Conduct audits and maintain traceability logs.
4. Accountability
The Production Manager is accountable for ensuring complete traceability of all dispensed materials used in manufacturing.
5. Procedure
5.1 Documentation of Dispensed Materials
- Maintain a Dispensed Material Log for each batch.
- Record the following details for each material:
- Material Name
- Batch Number
- Dispensed Quantity
- Weighed By
- Checked By
- Dispensing Date
- Ensure all entries are signed and dated by authorized personnel.
5.2 Labeling of Dispensed Materials
- Each container must have a unique identification label.
- The label should include:
- Material
Name
Batch Number
Weight
Dispensing Date
Operator’s Initials
Ensure labels are resistant to moisture and smudging.
5.3 Tracking and Traceability Records
- Maintain digital and physical records of dispensed materials.
- Each batch record should have traceability logs for raw materials used.
- Ensure that all material movements are documented in the ERP system.
5.4 Reconciliation of Dispensed Materials
- At the end of each batch, reconcile the actual dispensed quantities with batch records.
- Investigate and document any discrepancies in the Material Reconciliation Report.
- Obtain approval from QA for any deviations.
5.5 Handling of Non-Conforming Materials
- Any material with missing traceability data must be quarantined.
- QA must conduct an investigation and determine corrective actions.
- Non-conforming materials must be recorded in the Non-Conformance Report (NCR).
5.6 Record-Keeping
- Retain traceability records for the required duration as per regulatory guidelines.
- Ensure that all records are legible, complete, and readily accessible.
- Conduct periodic audits to verify record accuracy.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ERP – Enterprise Resource Planning
- NCR – Non-Conformance Report
7. Documents
- Dispensed Material Log (Annexure-1)
- Material Reconciliation Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7: Good Manufacturing Practice Guide
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Dispensed Material Log
| Date | Material Name | Batch Number | Dispensed Quantity | Weighed By | Checked By |
|---|---|---|---|---|---|
| 01/02/2025 | Material A | Batch 12345 | 5.00 kg | John Doe | QA Officer |
| 02/02/2025 | Material B | Batch 67890 | 3.50 kg | Jane Smith | QA Officer |
Annexure-2: Material Reconciliation Report
| Date | Material Name | Batch Number | Theoretical Quantity | Actual Quantity | Discrepancy | Remarks |
|---|---|---|---|---|---|---|
| 01/02/2025 | Material A | Batch 12345 | 5.00 kg | 5.01 kg | +0.01 kg | Acceptable |
| 02/02/2025 | Material B | Batch 67890 | 3.50 kg | 3.45 kg | -0.05 kg | Investigation required |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By | Page No. | Ref. Point No. | Details of Revision |
|---|---|---|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head | All | All | Created new SOP |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head | All | All | Revised to meet new documentation standards |