Qualification of Equipment in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for equipment qualification in formulation development, ensuring that equipment used in manufacturing processes is suitable for its intended purpose and meets regulatory requirements.

2) Scope

This SOP applies to all formulation development activities within the organization, covering the qualification of equipment used in the production, testing, and storage of pharmaceutical formulations.

3) Responsibilities

The responsibilities for this SOP include:
Formulation Development Team: Implementing equipment qualification activities and ensuring compliance with qualification protocols.
Quality Assurance: Reviewing and approving equipment qualification protocols and reports to ensure adherence to regulatory standards.
Engineering: Conducting equipment installation, operational, and performance qualification (IQ/OQ/PQ) activities as per defined protocols.
Regulatory Affairs: Ensuring that equipment qualification activities comply with regulatory requirements and guidelines.

4) Procedure

4.1 Installation Qualification (IQ)

1. Verify that equipment is delivered and installed correctly according to manufacturer specifications and design requirements.
2. Inspect equipment components, utilities connections, and documentation to ensure proper installation.
3. Document installation verification activities and findings in the IQ protocol.

4.2 Operational Qualification (OQ)

1. Conduct operational tests to verify that equipment operates according to predefined specifications and operational limits.
2. Perform tests on critical functions, controls, alarms, and safety features of the equipment.
3. Document operational qualification tests, results, and deviations in the OQ protocol.

4.3 Performance Qualification (PQ)

1. Execute performance tests to demonstrate that equipment consistently produces results within specified parameters under simulated operational conditions.
2. Challenge equipment with worst-case scenarios and operational variations to evaluate performance robustness.
3. Document performance qualification tests, acceptance criteria, and results in the PQ protocol.

4.4 Requalification and Maintenance

1. Establish a requalification schedule based on equipment criticality, usage frequency, and regulatory requirements.
2. Perform periodic requalification activities according to the defined schedule or after significant equipment modifications.
3. Maintain equipment in a validated state through regular calibration, preventive maintenance, and documentation of maintenance activities.

4.5 Change Control and Documentation

1. Implement change control procedures for equipment modifications, upgrades, or replacements that may impact qualification status.
2. Update equipment qualification documentation, including protocols, reports, and validation summaries, to reflect any changes.
3. Archive equipment qualification records and documentation for regulatory inspections and audit purposes.

5) Abbreviations, if any

SOP: Standard Operating Procedure
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification

6) Documents, if any

Equipment IQ/OQ/PQ Protocols
Equipment Maintenance Records
Change Control Records
Equipment Qualification Reports

7) Reference, if any

– FDA Guidance for Industry: Process Validation: General Principles and Practices
– ICH Q9: Quality Risk Management

8) SOP Version

Version 1.0