SOP for Validation of Computerized Systems in Pharmaceutical Manufacturing

1) Purpose

To establish procedures for the validation of computerized systems used in pharmaceutical manufacturing processes to ensure data integrity, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all computerized systems used in the pharmaceutical manufacturing facility, including but not limited to process control systems, laboratory information management systems (LIMS), and electronic batch records (eBR).

3) Responsibilities

Quality Assurance: Responsible for overseeing the implementation of computerized systems validation.
IT Department: Responsible for technical support and validation of computerized systems.
Production Team: Responsible for user requirements and operational testing.
Validation Team: Responsible for executing validation protocols and documenting results.

4) Procedure

1. System Classification:
   1. Classify computerized systems based on criticality and impact on product quality and data integrity.
   2. Determine the validation approach (e.g., prospective, retrospective, or concurrent validation).
2. User Requirements Specification (URS):
   1. Define and document user requirements for each computerized system.
   2. Include functional and non-functional requirements, security controls, and data integrity measures.
3. Validation Protocols:
   1. Develop validation protocols (Installation Qualification [IQ], Operational Qualification [OQ], Performance Qualification [PQ]).
   2. Specify testing procedures, acceptance criteria, and test results documentation.
4. Execution of Validation:
   1. Execute validation protocols according to approved procedures.
   2. Document deviations and corrective actions during testing.
5. Validation Report:
   1. Compile validation results and prepare a final validation report.
   2. Include summary of findings, deviations, and conclusions.

5) Abbreviations, if any

IQ – Installation Qualification

OQ – Operational Qualification

PQ – Performance Qualification

6) Documents, if any

• User Requirements Specifications (URS)
• Validation Protocols and Reports
• Deviation and Corrective Action Reports

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0