1.0 Purpose

This SOP defines the validation process, encompassing the philosophy, responsibilities, procedures, documentation requirements, and revalidation program, to ensure consistent production of products meeting pre-determined specifications and quality attributes.

2.0 Scope

This SOP applies to all validation activities related to new and existing equipment, processes, and systems within the manufacturing facility.

3.0 Definitions

• Validation: Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
• Impact Assessment: Evaluating the potential impact of changes or validation activities on systems, services, and products.
• EHS Audit: Environmental, Health, and Safety audit, incorporating risk assessment activities, performed by EHS management.
• Revalidation: Repeating the validation process to confirm that the validated equipment/process/system continues to perform as specified after changes or a defined period.
• IQ (Installation Qualification): Demonstrates that equipment is installed correctly and according to manufacturer specifications.
• OQ (Operational Qualification): Demonstrates that the equipment operates within specified parameters throughout the defined operating ranges.
• PQ (Performance Qualification): Demonstrates that the process consistently produces product meeting pre-determined specifications under normal operating conditions.

4.0 Philosophy of Validation

Validation is crucial for ensuring product quality and compliance with Good Manufacturing Practices (GMP). It relies on comprehensive documentation, including SOPs, batch records, change control systems, investigation reports, analytical documentation, development reports, validation protocols, and reports. All validation documentation is readily accessible to operations personnel and serves as a resource for ongoing operations, process development, and modifications.

An Impact Assessment is conducted for all validation activities to identify affected systems, services, and products. An EHS Audit, including risk assessment, is performed by EHS management for all product lines to address safety concerns.

A revalidation program is implemented based on routine equipment revalidation requirements and the Change Control Policy (SOP QMS-030).

5.0 Responsibilities

• Project Manager: Responsible for sourcing resources, assigning responsibilities, and obtaining agreement for project participation. This includes considering required skills, facilities, equipment, technology, suppliers/contractors, materials, capital funds, and special resources.
• Project Team: Assembled for specific validation projects, comprised of members from relevant departments, cross-functional areas, and contractors.
• Validation Manager/Project Coordinator: Responsible for overseeing the validation project, managing documentation, and ensuring compliance with this SOP.
• Quality Assurance Manager: Reviews and approves validation plans and reports.
• Review Team: Includes, at a minimum, the Quality Assurance Manager and Validation Manager. Additional reviewers may be identified in the individual Validation Plan.

6.0 Validation Documentation

The following documents are required for each validation project:

1. Validation Project Log Form (Form-375)
2. Validation Plan
3. Installation Qualification Report(s)
4. Operational Qualification Test Protocols and Raw Data Results
5. Operational Qualification Report
6. EHS Report
7. Quality Audit Report (for new process lines)
8. Performance Qualification Test Protocols and Raw Data Results
9. Validation Report
10. Discrepancy Forms
11. List of relevant System SOPs
12. System Changes (Change Request Forms per SOP QMS-030)

6.1 General Documentation Requirements

• All validation documents must have numbered pages, clearly stated units of measure, results/signatures recorded in black or blue ink, and signatures with dates for all tests performed.
• Original approved validation documents are the responsibility of the Project Coordinator (typically the Validation Manager). They are stored securely, and copies are issued in a controlled manner. Originals are included in the Validation File.
• Raw data (result sheets, temperature recordings, etc.) must be signed and dated by the person performing the test and included in the Validation file. OQ and PQ protocols and raw data are filed separately within the Validation file. The person responsible for checking and approving completed protocols ensures data accuracy.
• Validation files are numbered and indexed for easy review and include a section to record changes made to the validated equipment/process/system per SOP QMS-030.

6.2 Validation Document Numbering System

• The Project Coordinator registers the validation project with the Validation Department using Form-375.
• The Validation Department assigns a unique Project Number to each project. This number is used for all associated documentation.
• Validation documents are numbered sequentially within each document type (e.g., VP-001, IQ-001, OQ-001, PQ-001).

7.0 Installation Qualification (IQ)

• 7.1 Objectives: Verify that the equipment is installed according to design specifications and manufacturer recommendations.
• 7.2 Activities:
  • Review supplier installation inspections.
  • Review instrument data sheets.
  • Verify operating documentation (supplier operating & maintenance manuals).
  • Prepare equipment and instrument lists (including vendor, model, serial number, calibration certificates, motor/agitator/pump details, spare parts lists, and preventative maintenance schedules).
  • Verify materials of construction and lubricants in potential product contact conform to specifications.
  • Verify utilities are installed and available as specified.
  • Verify relevant SOPs are in place and personnel are trained.
• 7.3 Acceptance Criteria: All required documentation is obtained and filed. Change control is implemented from the start of IQ. All discrepancies are resolved.

8.0 Operational Qualification (OQ)

• 8.1 Objectives: Demonstrate that the system operates as intended throughout the specified design, operational, or approved acceptance range.
• 8.2 Activities:
  • Develop and execute OQ protocols based on the Validation Plan.
  • Record test instrumentation details and calibration certificates.
  • Conduct tests to verify equipment functionality and performance within operating ranges.
• 8.3 Acceptance Criteria: The system operates as intended across all specified ranges. All test results meet pre-defined acceptance criteria.

9.0 Performance Qualification (PQ)

• 9.1 Objectives: Demonstrate that the process consistently produces product meeting pre-determined specifications under normal operating conditions.
• 9.2 Activities:
  • Execute PQ protocols based on the Validation Plan and OQ results.
  • Use materials representative of normal production.
  • Typically involves three consecutive successful production runs.
• 9.3 Acceptance Criteria: All product quality attributes meet pre-determined specifications in all three production runs.

10.0 Validation Report

The Validation Report summarizes all OQ and PQ activities and results. It addresses the requirements of the Validation Program and Validation Plan. Approval of this report signifies full approval of the equipment/system for routine production use and stipulates the required Revalidation program.

11.0 Revalidation

Revalidation is performed periodically or after changes to the equipment/process/system to ensure continued validation status. The frequency and scope of revalidation are defined in the Validation Report and the Revalidation program.

12.0 General Validation Program Activities

• All validation projects are logged with the Validation Department and assigned a unique project number.
• All DQ, IQ, OQ, and PQ protocols define acceptance criteria and are reviewed and approved before execution.
• Calibrated instruments are used for all checks and testing.
• Only validated test methods are used.
• All qualification test results are recorded, including those that do not meet acceptance criteria.
• Test results are clearly documented and compared to acceptance criteria.
• Results are reviewed by the same team members who approved the protocol.
• An effective change control procedure is in place throughout the project.

13.0 Deviation Management

Any deviations from the approved protocols or acceptance criteria are documented using Discrepancy Forms. These deviations are investigated, and corrective actions are implemented. The impact of the deviation on the validation status is assessed.

14.0 Training

All personnel involved in validation activities receive appropriate training on this SOP and relevant procedures.

15.0 Review and Approval

This SOP is reviewed and approved by the Quality Assurance Manager and other relevant personnel.

16.0 Revision History

(Include a table with revision number, date, and description of changes)