Procedure for Cross-Contamination Prevention During Dispensing
| Department | Production/Quality Assurance |
|---|---|
| SOP No. | SOP/Ointment/007 |
| 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 procedures for preventing cross-contamination during the dispensing of raw materials for ointment manufacturing. This ensures product integrity, compliance with Good Manufacturing Practices (GMP), and patient safety.
2. Scope
This SOP applies to all personnel involved in the dispensing of raw materials, including active pharmaceutical ingredients (APIs) and excipients, within the manufacturing facility. It includes guidelines on area segregation, equipment use, personnel hygiene, and cleaning validation.
3. Responsibilities
- Production Operator: Ensures proper handling of raw materials to prevent contamination.
- Quality Control (QC) Personnel: Conducts in-process checks to verify contamination control measures.
- Production Supervisor: Ensures compliance with cross-contamination prevention protocols.
- Quality Assurance (QA) Officer: Conducts audits and verifies adherence to contamination control practices.
4. Accountability
The Production Manager is accountable for implementing and ensuring compliance with cross-contamination prevention measures during dispensing.
5. Procedure
5.1 Environmental Controls
- Ensure that the dispensing area is segregated and maintained under controlled conditions.
- Use a dedicated dispensing booth with a unidirectional airflow system to minimize contamination.
- Monitor temperature, humidity, and airflow to ensure compliance with GMP standards.
5.2 Equipment Controls
- Use dedicated
scoops, spatulas, and containers for different raw materials.
Clean and sanitize weighing balances before and after each use.
Ensure that weighing balances are properly covered when not in use.
5.3 Personnel Hygiene and Gowning
- All personnel must wear designated protective clothing, including gloves, masks, hairnets, and gowns.
- Change gloves and sanitize hands before handling each new material.
- Personnel must undergo training on contamination control measures.
5.4 Handling of Raw Materials
- Dispense one material at a time to avoid cross-contact.
- Ensure all materials are properly labeled and segregated.
- Use color-coded containers to differentiate raw materials.
5.5 Cleaning and Sanitation
- Follow the cleaning procedure for dispensing booths, weighing stations, and utensils.
- Record all cleaning activities in the Cleaning Log.
- Conduct periodic microbial and particle testing in the dispensing area.
5.6 Documentation and Record-Keeping
- Maintain logs for equipment use, material dispensing, and cleaning activities.
- Ensure all records are reviewed and approved by QA.
- Keep documentation updated and readily accessible for audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- API – Active Pharmaceutical Ingredient
7. Documents
- Cleaning Log (Annexure-1)
- Cross-Contamination Prevention Checklist (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: Cleaning Log
| Date | Equipment/Area Cleaned | Cleaning Agent Used | Cleaned By | Checked By |
|---|---|---|---|---|
| 01/02/2025 | Dispensing Booth | 70% IPA | John Doe | QA Officer |
| 02/02/2025 | Weighing Balance | Distilled Water | Jane Smith | QA Officer |
Annexure-2: Cross-Contamination Prevention Checklist
| Date | Step Verified | Verified By | Comments |
|---|---|---|---|
| 01/02/2025 | Dedicated utensils used | QA Officer | Compliant |
| 02/02/2025 | Gloves changed before material handling | QA Officer | Compliant |
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 |