Procedure for Preventing Mix-Ups During Dispensing
| Department | Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse |
|---|---|
| SOP No. | SOP/Ointment/177 |
| 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 to prevent mix-ups during the dispensing of raw materials in pharmaceutical manufacturing. Preventing mix-ups ensures product integrity, reduces contamination risks, and maintains compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.
2. Scope
This SOP applies to all personnel involved in the dispensing, verification, and storage of raw materials in the Production, Quality Assurance (QA), Quality Control (QC), and Warehouse departments.
3. Responsibilities
- Dispensing Operator: Ensures correct material identification, handling, and segregation.
- QA Officer: Monitors dispensing activities and verifies materials to prevent mix-ups.
- QC Analyst: Conducts random checks to ensure accuracy of dispensed materials.
- Warehouse Supervisor: Ensures proper storage and segregation of raw materials.
- Production Supervisor: Oversees the dispensing process and ensures adherence to protocols.
4. Accountability
The QA Manager is accountable for ensuring that all dispensing activities comply with GMP, FDA, ICH, WHO, and company policies to prevent mix-ups.
5. Procedure
5.1 Preparation for Dispensing
- Ensure the **dispensing room is clean and free from contamination risks.**
- Verify that the **Batch Manufacturing Record (BMR)** is available and
contains accurate material details.
Ensure proper environmental conditions:
Confirm that the weighing balance is **calibrated and in proper working condition.**
Ensure that each raw material container has a **clear and legible label** with the following information:
- Temperature: **15-25°C**
- Humidity: **30-50% RH**
- Material Name
- Batch Number
- Expiration Date
- Weighed Quantity
- Operator Name
5.2 Dispensing Process
- Only one raw material should be dispensed at a time to **eliminate mix-up risks.**
- Use a **pre-designated dispensing station** for each raw material.
- Ensure that weighing and dispensing containers are labeled correctly before use.
- During dispensing:
- Cross-check the raw material with the **Batch Manufacturing Record (BMR).**
- Verify the material’s identity using **pre-approved specifications.**
- Label each dispensed material **immediately after weighing.**
- Record the dispensed material details in the **Dispensing Log (Annexure-1).**
5.3 Handling Mix-Up Risks
- If a mix-up is suspected:
- Immediately stop the dispensing process.
- Inform the **QA department and Production Supervisor.**
- Isolate the incorrect material and conduct a re-verification.
- Record the incident in the **Mix-Up Deviation Log (Annexure-2).**
- If a mix-up is confirmed:
- The affected batch must be **quarantined and reviewed for corrective action.**
- Retrain operators on mix-up prevention procedures.
5.4 Post-Dispensing Activities
- Ensure that all dispensed materials are **stored in properly labeled containers.**
- Verify that materials are placed in **designated holding areas before transfer.**
- QA must **sign off on the Dispensing Log (Annexure-1)** before materials proceed to manufacturing.
5.5 Periodic Review and Audit
- QA must perform **weekly random checks** on dispensing logs.
- Deviations must be analyzed in **monthly review meetings.**
- Records must be **retained for five years** for compliance audits.
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
- Dispensing Log (Annexure-1)
- Mix-Up Deviation Log (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO Guidelines on Good Dispensing 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: Dispensing Log
| Date | Material Name | Batch No. | Weighed Quantity | Operator | QA Review |
|---|---|---|---|---|---|
| 02/02/2025 | API X | SOP/Ointment/1001 | 5.0 kg | John Doe | Approved |
Annexure-2: Mix-Up Deviation Log
| Date | Material Name | Batch No. | Deviation Type | Root Cause | Corrective Action | QA Approval |
|---|---|---|---|---|---|---|
| 02/02/2025 | API X | SOP/Ointment/1001 | Incorrect Label | Operator Error | Reprinted Label | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Mix-Up Prevention Procedures | Improved Compliance | QA Head |