Procedure for Reviewing Dispensed Materials Before Manufacturing
| Department | Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse |
|---|---|
| SOP No. | SOP/Ointment/180 |
| 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 systematic approach for reviewing dispensed raw materials before they are used in the manufacturing process. Proper review ensures batch accuracy, compliance with Good Manufacturing Practices (GMP), and regulatory adherence.
2. Scope
This SOP applies to all personnel involved in the verification, approval, and handling of dispensed raw materials in the Production, Quality Assurance (QA), Quality Control (QC), and Warehouse departments.
3. Responsibilities
- Dispensing Operator: Ensures accurate dispensing of materials before submission for review.
- QA Officer: Reviews dispensed materials for compliance with batch requirements.
- QC Analyst: Conducts quality checks and confirms the integrity of dispensed materials.
- Warehouse Supervisor: Ensures proper storage and labeling of dispensed materials.
- Production Supervisor: Oversees the review process before manufacturing begins.
4. Accountability
The QA Manager is accountable for ensuring that all review activities comply with GMP, FDA, ICH, WHO, and company policies.
5. Procedure
5.1 Preparation for Review
- Ensure that the **Batch Manufacturing Record (BMR)** is available for reference.
- Verify that the dispensing area is clean and free from contaminants.
- Ensure that all materials
are labeled correctly, including:
- Material Name
- Batch Number
- Dispensed Quantity
- Weighing Date
- Operator Name
- QA Verification Status
5.2 Review of Dispensed Materials
- Each dispensed material must be reviewed against the **Batch Manufacturing Record (BMR).**
- QA must confirm that the **dispensed weight matches the prescribed batch formula.**
- QC must verify that:
- Materials meet quality specifications.
- Materials are free from contamination or degradation.
- Packaging integrity is maintained.
- Verify that all materials are stored under appropriate environmental conditions.
- Record the review details in the **Dispensed Material Review Log (Annexure-1).**
5.3 Handling Deviations in Dispensed Materials
- If any discrepancies are found:
- Stop further processing immediately.
- Isolate the affected material and label it as **”Hold for Investigation.”**
- Notify the QA department for assessment.
- Record the deviation in the **Dispensed Material Deviation Log (Annexure-2).**
- If a material is found to be out of specification:
- QA must determine whether the material should be reweighed or discarded.
- Corrective actions must be implemented before batch processing begins.
5.4 Approval for Manufacturing
- Once all dispensed materials are reviewed and approved:
- QA must sign off on the **Dispensed Material Review Log (Annexure-1).**
- Materials are transferred to the manufacturing area.
- No material can be used in manufacturing without documented approval.
5.5 Periodic Review and Audit
- QA must conduct **weekly random sampling** of reviewed materials.
- All deviations must be assessed in **monthly QA meetings** to identify trends and corrective actions.
- Records must be **retained for five years** for audit and compliance purposes.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Dispensed Material Review Log (Annexure-1)
- Dispensed Material Deviation Log (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO Guidelines on Good Manufacturing Practices
- FDA Guidance on Pharmaceutical Manufacturing
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 Review Log
| Date | Material Name | Batch No. | Dispensed Quantity | Operator | QA Review |
|---|---|---|---|---|---|
| 02/02/2025 | API X | SOP/Ointment/1001 | 5.0 kg | John Doe | Approved |
Annexure-2: Dispensed Material Deviation Log
| Date | Material Name | Batch No. | Deviation Type | Root Cause | Corrective Action | QA Approval |
|---|---|---|---|---|---|---|
| 02/02/2025 | API X | SOP/Ointment/1001 | Incorrect Weight | Operator Error | Reweighed | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Review Procedures | Improved Compliance | QA Head |