SOP for Validation of Manufacturing Processes – V 2.0

Procedure for Validation of Manufacturing Processes

Department	Quality Assurance (QA)/Quality Control (QC)/Production
SOP No.	SOP/Ointment/084
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 define a structured process for validating manufacturing processes in ointment production. Process validation ensures that manufacturing activities consistently produce products that meet predefined quality standards and regulatory requirements.

2. Scope

This SOP applies to all personnel in the Production, Quality Assurance (QA), and Quality Control (QC) departments involved in the validation of manufacturing processes, including mixing, heating, filling, and packaging.

3. Responsibilities

Production Operator: Performs manufacturing activities as per validated procedures.
Production Supervisor: Ensures process parameters are followed and recorded.
Quality Control (QC) Analyst: Conducts in-process and final product testing.
Quality Assurance (QA) Officer: Reviews validation protocols, ensures compliance, and approves validation reports.
Validation Team: Conducts process qualification studies and risk assessments.

4. Accountability

The QA Manager and Validation Team are accountable for ensuring that all manufacturing processes are validated and compliant with Good Manufacturing Practices (GMP).

5. Procedure

5.1 Validation Planning

Define the scope, objectives, and responsibilities of process validation.
Prepare a Validation Master Plan (VMP) outlining the validation approach.
Identify critical process parameters (CPP) and critical quality attributes (CQA).
Establish acceptance criteria for validation.

5.2 Process Design Qualification (DQ)

Ensure that equipment and facilities meet GMP design requirements.
Verify equipment installation, calibration, and maintenance records.
Review raw material specifications and ensure compatibility with process design.

5.3 Process Performance Qualification (PQ)

Conduct trial production runs under controlled conditions.
Collect process data, including mixing time, temperature, and viscosity.
Analyze process variability and consistency across multiple batches.

5.4 Process Validation Execution

5.4.1 Validation Batches

Perform three consecutive full-scale manufacturing runs.
Monitor and record in-process parameters at critical points.
Ensure batch-to-batch consistency in product characteristics.

5.4.2 Analytical Testing

Conduct active ingredient assay, pH testing, and microbial analysis.
Ensure uniformity of dosage and absence of contamination.
Compare results against predefined acceptance criteria.

5.4.3 Stability Studies

Conduct accelerated and real-time stability testing.
Monitor physical and chemical stability over time.
Ensure product retains its intended quality throughout its shelf life.

5.5 Process Validation Report (PVR)

Summarize validation findings and statistical analyses.
Document deviations and corrective actions taken.
Obtain QA approval before the manufacturing process is officially validated.

5.6 Continuous Process Verification

Monitor validated processes periodically to detect potential variations.
Implement corrective actions if deviations exceed acceptable limits.
Revalidate processes as per regulatory guidelines or after significant process changes.

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
QC – Quality Control
CPP – Critical Process Parameter
CQA – Critical Quality Attribute
PQ – Process Qualification
PVR – Process Validation Report

7. Documents

Validation Master Plan (Annexure-1)
Process Validation Report (Annexure-2)

8. References

WHO GMP Guidelines for Pharmaceutical Manufacturing
ICH Q8 – Pharmaceutical Development
USP <1225> – Validation of Compendial Procedures

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Validation Master Plan

Validation Activity	Objective	Responsible Department	Status
Process Design Qualification	Ensure facility & equipment meet GMP standards	QA/Engineering	Completed
Process Performance Qualification	Verify consistency across batches	Production/QA	Completed
Analytical Testing	Confirm product quality attributes	QC	Completed

Annexure-2: Process Validation Report

Date	Batch Number	Process Step	Tested Parameter	Result	Acceptance Criteria	Status
01/02/2025	OINT-101	Mixing	Temperature	65°C	60-70°C	Pass
01/02/2025	OINT-101	Filling	Volume	30g ± 1g	Within limits	Pass

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