SOP for Adjusting Batch Sizes According to Production Needs – V 2.0

Procedure for Adjusting Batch Sizes According to Production Needs

Department	Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Planning
SOP No.	SOP/Ointment/197
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 guidelines for adjusting batch sizes in ointment production to align with market demand, production efficiency, and resource availability while ensuring compliance with GMP regulations.

2. Scope

This SOP applies to manufacturing, production planning, and quality assurance personnel involved in determining and adjusting batch sizes in accordance with production needs.

3. Responsibilities

Production Manager: Ensures batch size adjustments comply with GMP and regulatory requirements.
Planning Department: Analyzes market demand, forecasts production needs, and proposes batch adjustments.
QA Officer: Verifies that changes in batch size do not affect product quality or stability.
QC Analyst: Conducts required tests to ensure consistency across different batch sizes.
Manufacturing Supervisor: Implements the approved batch size adjustments and documents changes.

4. Accountability

The Head of Production is accountable for ensuring that batch size adjustments follow GMP guidelines and maintain product quality standards.

5. Procedure

5.1 Reviewing Production Needs

Assess demand fluctuations using sales forecasts and market analysis.
Evaluate current production capacity and resource availability.
Document production requirements in the **Batch Size Adjustment

Log (Annexure-1).**

5.2 Determining Batch Adjustment Parameters

Identify allowable batch size variations based on equipment capacity.
Ensure batch adjustments do not affect critical quality attributes (CQAs).
Record planned adjustments in the **Batch Adjustment Plan (Annexure-2).**

5.3 Implementing Batch Adjustments

Obtain QA and regulatory approval before modifying batch sizes.
Communicate batch size changes to all relevant departments.
Maintain documentation in the **Batch Adjustment Implementation Log (Annexure-3).**

5.4 Post-Adjustment Quality Control

Conduct in-process and finished product testing for adjusted batches.
Compare quality data with historical batch records.
Document test results in the **Quality Verification Report (Annexure-4).**

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
QC – Quality Control
CQA – Critical Quality Attributes
SOP – Standard Operating Procedure

7. Documents

Batch Size Adjustment Log (Annexure-1)
Batch Adjustment Plan (Annexure-2)
Batch Adjustment Implementation Log (Annexure-3)
Quality Verification Report (Annexure-4)

8. References

FDA Guidance on Process Validation
ICH Q8 – Pharmaceutical Development Guidelines
WHO Guidelines on Production Planning

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 Adjustment Log

Date	Batch No.	Current Batch Size	Adjusted Batch Size	Reason for Adjustment	QA Approval
04/02/2025	OINT-7001	500 kg	750 kg	Increased demand	Approved

Annexure-2: Batch Adjustment Plan

Date	Batch No.	Adjustment Plan	Equipment Capacity Verified	QA Approval
04/02/2025	OINT-7001	Increase batch by 50%	Yes	Approved

Annexure-3: Batch Adjustment Implementation Log

Date	Batch No.	Adjustment Implemented	Deviation Noted	QA Approval
05/02/2025	OINT-7001	Yes	No	Approved

Annexure-4: Quality Verification Report

Date	Batch No.	Quality Test Performed	Result	QA Approval
06/02/2025	OINT-7001	Viscosity Check	Pass	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
06/02/2025	2.0	Updated batch adjustment process	Process Optimization	QA Head
01/01/2024	1.0	Initial SOP	New SOP Implementation	QA Head