Procedure for Handling and Labeling Dispensed Materials
| Department | Production/Quality Control |
|---|---|
| SOP No. | SOP/Ointment/005 |
| 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
This Standard Operating Procedure (SOP) provides guidelines for the proper handling and labeling of dispensed raw materials in ointment manufacturing. The objective is to prevent contamination, ensure traceability, and maintain compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all dispensed raw materials, including active pharmaceutical ingredients (APIs), excipients, and additives used in ointment production. It covers procedures for handling, labeling, documentation, and storage.
3. Responsibilities
- Production Operator: Responsible for handling and labeling dispensed materials correctly.
- Quality Control (QC) Personnel: Verify compliance with labeling and handling requirements.
- Production Supervisor: Ensure GMP compliance during material handling.
- Quality Assurance (QA) Officer: Conduct periodic audits to verify adherence to procedures.
4. Accountability
The Production Manager is accountable for ensuring that all dispensed materials are correctly handled and labeled as per the established guidelines.
5. Procedure
5.1 Handling of Dispensed Materials
- Ensure the dispensing area is clean and free from cross-contamination.
- Use dedicated containers for different types of raw materials.
- Handle materials with clean, dry, and sanitized gloves.
- Ensure that the dispensed quantity matches the Batch Manufacturing Record (BMR).
- Keep materials in covered containers to
prevent contamination.
Avoid direct contact with raw materials to maintain hygiene and product integrity.
5.2 Labeling of Dispensed Materials
- Each dispensed material must be labeled immediately after weighing.
- The label should include the following information:
- Material Name
- Batch Number
- Weight (Dispensed Quantity)
- Dispensing Date
- Expiration Date
- Storage Conditions
- Operator Name and Signature
- Use color-coded labels for easy identification.
- Ensure that labels are legible, securely attached, and resistant to smudging.
5.3 Verification of Labeled Materials
- QC personnel must cross-check dispensed materials against batch records.
- Ensure that the information on the label matches the corresponding Batch Manufacturing Record (BMR).
- Record the verification in the Labeling Log.
- Any discrepancies should be reported to QA for corrective action.
5.4 Storage of Dispensed Materials
- Store dispensed materials in designated areas with proper segregation.
- Ensure that sensitive materials are stored under controlled temperature and humidity.
- Keep materials covered and properly labeled until they are used in production.
5.5 Handling of Labeling Errors
- If incorrect labeling is identified, the material must be quarantined immediately.
- Report the incident to the QA department for investigation.
- Correct the label under QA supervision and record the correction in the Labeling Log.
- Rejected labels must be disposed of securely to prevent misuse.
5.6 Record-Keeping
- Maintain accurate records of all dispensed materials.
- Ensure that all labeling logs are signed and verified by authorized personnel.
- Retain records as per regulatory requirements.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Labeling Log (Annexure-1)
- Dispensed Material Storage Log (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: Labeling Log
| Date | Material Name | Batch Number | Dispensed Quantity | Labeled By | Verified 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: Dispensed Material Storage Log
| Date | Material Name | Batch Number | Storage Location | Temperature (°C) | Humidity (%) |
|---|---|---|---|---|---|
| 01/02/2025 | Material A | Batch 12345 | Rack A1 | 22 | 45 |
| 02/02/2025 | Material B | Batch 67890 | Rack B2 | 25 | 50 |
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 |