Procedure for Documenting Process Validation Studies

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a standardized process for documenting process validation studies in ointment manufacturing. Proper documentation ensures traceability, regulatory compliance, and consistency in product quality.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Production, and Research & Development (R&D) departments responsible for recording, maintaining, and reviewing process validation documentation.

3. Responsibilities

• QA Officer: Ensures proper documentation and regulatory compliance of process validation studies.
• Production Supervisor: Provides process details and operational parameters for documentation.
• Validation Team: Records validation parameters, testing results, and deviations.
• R&D Scientist: Defines critical process parameters and assesses study results.
• QA Manager: Approves process validation reports and ensures regulatory compliance.

4. Accountability

The QA and R&D Managers are accountable for ensuring that process validation documentation aligns with GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Validation Documentation Requirements

• Process validation documentation must include:
  • Validation Plan
  • Validation Protocol
  • Raw Data Collection
  • Test Results and Acceptance Criteria
  • Deviation Reports (if applicable)
  • Final Validation Report
• Ensure records are complete, legible, and properly signed off.

5.2 Execution of Process Validation

• Conduct a minimum of three consecutive