Procedure for Weighing of Raw Materials for Ointment Manufacturing
| Department | Production/Quality Control |
|---|---|
| SOP No. | SOP/Ointment/004 |
| 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 guidelines for accurately weighing raw materials for ointment manufacturing. This ensures compliance with Good Manufacturing Practices (GMP), maintains batch consistency, and prevents cross-contamination.
2. Scope
This SOP applies to the weighing of all raw materials used in ointment production. It includes equipment calibration, environmental conditions, weighing procedures, and documentation requirements.
3. Responsibilities
- Production Operator: Responsible for executing the weighing process as per batch records.
- Quality Control (QC) Personnel: Ensures the accuracy of weighed materials.
- Production Supervisor: Verifies compliance with standard procedures.
- Quality Assurance (QA) Officer: Conducts audits and ensures GMP compliance.
4. Accountability
The Production Manager is accountable for ensuring that all weighing activities are conducted according to established procedures.
5. Procedure
5.1 Pre-Weighing Preparations
- Ensure that the dispensing area is clean and free from any contamination.
- Verify that all weighing balances are calibrated and within tolerance limits.
- Ensure that the required personal protective equipment (PPE) is worn.
- Check that the required raw materials are available and properly labeled.
5.2 Verification of Raw Materials
- Confirm that the raw material name,
batch number, and expiry date match the batch manufacturing record (BMR).
Ensure that the Certificate of Analysis (CoA) has been approved.
Inspect packaging integrity before weighing.
5.3 Weighing Procedure
- Use dedicated, labeled weighing balances for different types of raw materials to prevent cross-contamination.
- Weigh each raw material as per the approved batch manufacturing formula.
- Record the actual weighed quantity in the Weighing Log.
- For each material, use separate scoops and containers to avoid contamination.
- Ensure that the balance display is stable before noting the weight.
5.4 Handling of Deviations
- If any material is over- or under-weighed, document the deviation and obtain approval from QA before adjusting.
- If contamination occurs, discard the material following standard disposal procedures.
- Report any weighing discrepancies to the Production Supervisor immediately.
5.5 Post-Weighing Procedure
- Return unused raw materials to their designated storage areas.
- Ensure all weighed materials are labeled with material name, batch number, and weight.
- Clean weighing equipment and the surrounding area.
- Ensure all records are signed and countersigned by authorized personnel.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- CoA – Certificate of Analysis
7. Documents
- Weighing Log (Annexure-1)
- Calibration Record (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: Weighing Log
| Date | Material Name | Batch Number | Theoretical Weight (kg) | Actual Weight (kg) | Weighed By |
|---|---|---|---|---|---|
| 01/02/2025 | Material A | Batch 12345 | 5.00 | 5.01 | John Doe |
| 02/02/2025 | Material B | Batch 67890 | 3.50 | 3.49 | Jane Smith |
Annexure-2: Calibration Record
| Date | Balance ID | Calibration Standard | Result | Checked By |
|---|---|---|---|---|
| 01/02/2025 | Balance-01 | 5.000 kg Standard | 5.001 kg | QA Officer |
| 02/02/2025 | Balance-02 | 3.000 kg Standard | 2.999 kg | QA Officer |
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 |