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:
• Temperature: **15-25°C**
• Humidity: **30-50% RH**
• 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:
• 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