Standard Operating Procedure for Handling Overages in Batch Preparation of Elixirs

Department	Elixir Department
SOP No.	SOP/ELX/071/2025
Supersedes	SOP/ELX/071/2022
Page No.	Page 1 of 8
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To establish a procedure for the identification, documentation, and appropriate handling of overages observed during batch preparation of elixirs in order to ensure regulatory compliance and product quality.

2. Scope

This SOP applies to all batch manufacturing operations in the Elixir Department where raw material or product overages may occur during dispensing, mixing, or volume adjustments.

3. Responsibilities

• Production Operator:
  • Report any overages immediately to the supervisor and record in the BMR.
  • Ensure all excess material is properly labeled and segregated.
• Production Supervisor:
  • Verify the overage quantity and initiate further action based on type of overage.
  • Ensure reconciliation of actual vs theoretical yield is documented.
• QA Officer:
  • Review overage handling records and provide clearance or disposition instructions.

4. Accountability

The Production Head is accountable for ensuring all overages are handled as per this SOP and compliant with cGMP documentation practices.

5. Procedure

5.1 Types of Overages

1. Raw Material Overages: More than required quantity of materials weighed or transferred into manufacturing vessel.
2. Final Product Overages: Elixir volume exceeds theoretical volume post-processing due to measurement variation or adjustment errors.

5.2 Raw Material Overages

1. If overage is within ±0.5% of theoretical quantity:
   • Acceptable; document actual dispensed quantity in the BMR.
2. If overage exceeds ±0.5%:
   • Report immediately to the supervisor and QA.
   • Initiate deviation report and assess impact on batch quality.

5.3 Final Product Overages

1. Measure the final batch volume using calibrated dip stick or level sensor.
2. If excess volume is within 2%:
   • Document and proceed for filling after QA review.
3. If volume exceeds 2%:
   • Sample and test the overage portion for assay, pH, microbial quality.
   • Segregate excess in a separate labeled container as “Overage – Awaiting QA Disposition.”

5.4 Labeling and Storage

1. All overages must be labeled with:
   • Batch No.
   • Date
   • “Overage – Hold for QA Decision”
   • Container No. and Volume
2. Store in designated area with restricted access until disposition.

5.5 Disposition of Overages

1. Overages may be:
   • Used for filling, if approved by QA after testing.
   • Reprocessed (if validated) or destroyed as per waste SOP.
2. Update the BMR and complete the Overage Handling Log (Annexure-1).

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• cGMP: Current Good Manufacturing Practice

7. Documents

1. Overage Handling Log (Annexure-1)
2. Overage Label Template (Annexure-2)
3. Deviation Report (if applicable)

8. References

• 21 CFR Part 211.103 – Calculation of Yield
• WHO GMP Guidelines for Documentation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Overage Handling Log

Date	Batch No.	Type of Overage	Quantity	Disposition	QA Reviewed By
11/04/2025	ELX-1014	Final Product	4 Litres	Approved for Filling	Sunita Reddy

Annexure-2: Overage Label Template

Label Field	Example Entry
Material	Paracetamol Elixir
Batch No.	ELX-1014
Volume	4 L
Date	11/04/2025
Status	Overage – Hold for QA

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP Release	New SOP	QA Head
11/04/2025	2.0	Added Raw and Final Product Overage Handling Criteria	Process Clarification	QA Head