Standard Operating Procedure for Conducting Process Validation for Granules

1) Purpose

The purpose of this SOP is to define procedures for conducting process validation for granules production in the pharmaceutical industry to ensure consistency, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in process validation activities for granules production within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Assurance (QA) Department: Responsible for overseeing and approving process validation protocols.
Production Managers: Responsible for executing process validation studies and ensuring compliance.
Quality Control (QC) Department: Responsible for analyzing validation data and providing inputs.

4) Procedure

1. Protocol Development:
   1. Define the scope, objectives, and acceptance criteria for process validation.
   2. Develop a detailed validation protocol outlining study parameters, sampling plans, and test methods.
2. Process Qualification:
   1. Perform equipment qualification to ensure that all equipment used in the process is qualified and calibrated.
   2. Conduct process qualification runs under normal operating conditions to demonstrate process consistency.
3. Product Qualification:
   1. Prepare batches of granules according to the validated process.
   2. Perform in-process testing and sampling to verify product quality attributes.
4. Validation Report:
   1. Compile validation data and results into a comprehensive validation report.
   2. Review and analyze results against acceptance criteria.
5. Approval and Review:
   1. Submit the validation report to QA for review and approval.
   2. Implement any corrective actions or improvements identified during validation.
6. Documentation:
   1. Maintain complete documentation of all process validation activities, including protocols, reports, and approvals.
   2. Archive records in accordance with document control procedures and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control

6) Documents, if any

Validation Protocol, Validation Report, Equipment Qualification Documents

7) Reference, if any

ICH guidelines for pharmaceutical process validation.

8) SOP Version

Version 1.0