Procedure for Ensuring Proper Batch Size in Each Stage

Department	Production/Quality Assurance (QA)/Research and Development (R&D)
SOP No.	SOP/Ointment/039
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 standardized method for ensuring proper batch size at each stage of ointment manufacturing. Maintaining consistent batch size ensures product uniformity, process efficiency, and compliance with regulatory requirements.

2. Scope

This SOP applies to all personnel involved in batch size determination, verification, and adjustment during the ointment manufacturing process.

3. Responsibilities

• Production Supervisor: Ensures batch sizes adhere to formulation guidelines.
• Machine Operator: Monitors and adjusts equipment settings to maintain batch consistency.
• Quality Assurance (QA) Personnel: Verifies batch size compliance with GMP standards.
• R&D Scientist: Defines acceptable batch size ranges for each process stage.

4. Accountability

The Production and QA Managers are accountable for ensuring that batch size determination is conducted as per GMP standards and properly documented.

5. Procedure

5.1 Determining Batch Size

• Refer to the Batch Manufacturing Record (BMR) for the defined batch size.
• Verify availability of raw materials to meet batch requirements.
• Confirm equipment capacity aligns with the prescribed batch volume.

5.2 Ensuring Proper Batch Size at Different Stages

5.2.1 Raw Material Dispensing

• Weigh each raw material precisely using calibrated balances.
• Ensure all weighed materials match the defined batch size.
• Record actual weight and verify against target values.

5.2.2 Mixing and Emulsification

• Ensure correct proportions of active ingredients, excipients, and base materials.
• Adjust mixing vessel volume to prevent overflow or underfilling.
• Verify uniform dispersion before proceeding to the next stage.

5.2.3 Cooling and Solidification

• Monitor batch size to prevent loss due to evaporation or spills.
• Adjust cooling vessel capacity to accommodate full batch volume.
• Ensure no batch reduction due to excessive processing time.

5.2.4 Filling and Packaging

• Check for uniform batch division before transferring to the filling machine.
• Ensure final batch yield matches expected output after filling.
• Document any batch variations and report to QA for approval.

5.3 Handling Batch Size Deviations

• If batch size exceeds or falls below the allowable limit, halt production.
• Identify the cause (e.g., ingredient miscalculation, equipment error).
• Implement corrective actions and document in the Batch Size Deviation Log.

5.4 Documentation and Approval

• Record batch size measurements in the Batch Size Monitoring Log.
• QA must review and approve batch records before release.
• Retain batch size data for audit and compliance purposes.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• R&D – Research and Development

7. Documents

• Batch Size Monitoring Log (Annexure-1)
• Batch Size Deviation Log (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Size Monitoring Log

Date	Batch Number	Stage	Target Batch Size (Kg)	Actual Batch Size (Kg)	Verified By
01/02/2025	SOP/Ointment/001	Mixing	100	98	QA Officer
02/02/2025	SOP/Ointment/002	Filling	100	101	QA Officer

Annexure-2: Batch Size Deviation Log

Date	Batch Number	Stage	Deviation	Corrective Action	Approved By
02/02/2025	SOP/Ointment/002	Mixing	Batch volume reduced by 2%	Adjusted raw material ratio	QA Head
03/02/2025	SOP/Ointment/003	Filling	Overfill by 1%	Calibrated filling machine	QA Head

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head