Standard Operating Procedure for Control and Use of Primary Containers During Dispensing

Department	Elixir Department
SOP No.	SOP/ELX/025/2025
Supersedes	SOP/ELX/025/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define a standard procedure for the control, handling, labeling, and use of primary containers during the dispensing of raw materials in the Elixir Department, ensuring traceability and compliance with cGMP standards.

2. Scope

This SOP is applicable to all primary containers (original raw material containers, partially used containers, and repacked containers) used during the dispensing of raw materials for elixir manufacturing.

3. Responsibilities

• Dispensing Operator:
  • Ensure containers are handled hygienically and labeled correctly.
  • Seal and return unused materials properly.
• Warehouse Staff:
  • Maintain record of container movement and segregation.
• QA Officer:
  • Verify integrity and labeling of all containers during dispensing and after return.

4. Accountability

The Head of QA and Head of Warehouse are accountable for ensuring appropriate use and control of primary containers during dispensing operations.

5. Procedure

5.1 Verification of Containers

1. Check each container for:
   • Correct label (material name, code, batch number, expiry)
   • Physical condition – no leakage, dents, or tampering
   • Proper closure and tamper-evident seals
2. Confirm the material against the Material Requisition Slip and Approved Vendor List.

5.2 Use During Dispensing

1. Do not open more containers than required for the current batch.
2. Open containers only under controlled and clean environment (preferably under LAF).
3. Do not mix contents of two containers without QA approval.
4. Use separate scoops and weighing aids for each material.

5.3 Labeling Requirements

1. Ensure original manufacturer’s label remains intact and readable at all times.
2. If material is repacked, affix secondary label with:
   • Material name and code
   • Repack date and expiry
   • Repacked by and verified by
3. Label all partially used containers as “Partially Used” with remaining quantity, date, and signature (refer Annexure-1).

5.4 Handling of Unused Materials

1. Seal all partially used containers immediately after dispensing.
2. Wipe the exterior with lint-free cloth soaked in 70% IPA.
3. Transfer to the quarantine area for further disposition (reuse, re-testing, or disposal).

5.5 Rejected Containers

1. Segregate any container with damaged packaging, illegible labeling, or leakage.
2. Label as “REJECTED – DO NOT USE.”
3. Inform QA and record in the Rejection Log (Annexure-2).

5.6 Traceability and Documentation

1. Record container IDs, batch numbers, and quantity dispensed in the Dispensing Log.
2. Maintain traceability from receipt to issuance and return of containers.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• IPA: Isopropyl Alcohol

7. Documents

1. Partially Used Container Label (Annexure-1)
2. Container Rejection Log (Annexure-2)

8. References

• WHO TRS 986 Annex 2 – GMP Guidelines
• 21 CFR Part 211 – Subpart E: Control of Components

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Partially Used Container Label

Material Name	Batch No.	Remaining Qty	Date	Repacked/Used By	Verified By
Citric Acid	CA0425	3.0 kg	13/04/2025	Rajesh Kumar	Sunita Reddy

Annexure-2: Container Rejection Log

Date	Container ID	Material Name	Reason for Rejection	Rejected By	QA Verification
13/04/2025	CTN-0789	Glycerin	Seal Broken	Rajesh Kumar	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial SOP	New SOP	QA Head
13/04/2025	2.0	Added labeling and traceability protocols	Audit Recommendation	QA Head