Standard Operating Procedure for Equipment Qualification in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to define the procedures for equipment qualification to ensure that all manufacturing equipment used in the production of ocular dosage forms meets predetermined specifications and regulatory requirements.

2) Scope

This SOP applies to all equipment used in the manufacturing process of ocular dosage forms, including but not limited to mixing equipment, filling machines, sterilization units, and packaging machinery. It encompasses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

3) Responsibilities

The Quality Assurance (QA) department is responsible for implementing and overseeing equipment qualification activities. Production personnel are responsible for ensuring equipment is used according to approved procedures. Engineering and maintenance personnel provide technical support for equipment qualification and maintenance.

4) Procedure

4.1 Installation Qualification (IQ)

1. Verify that the equipment is delivered and installed according to manufacturer specifications and installation drawings.
2. Check that all components, utilities, and accessories required for operation are correctly installed.
3. Document the installation process and ensure compliance with site requirements.

4.2 Operational Qualification (OQ)

1. Ensure that the equipment operates according to predefined operational parameters and settings.
2. Verify that all operational functions, alarms, and safety features are tested and functioning correctly.
3. Perform performance tests to confirm the equipment operates within acceptable limits under simulated production conditions.

4.3 Performance Qualification (PQ)

1. Execute process simulations using the equipment to demonstrate its ability to consistently produce ocular dosage forms that meet specified requirements.
2. Collect and analyze data from PQ runs to verify the equipment’s capability to achieve desired process outputs.
3. Conduct challenge tests to assess equipment performance under worst-case conditions.

4.4 Requalification

1. Establish a requalification schedule based on risk assessment and regulatory requirements.
2. Perform periodic requalification activities to ensure equipment continues to operate within specified parameters.
3. Update qualification records and documentation following requalification activities.

5) Abbreviations, if any

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

6) Documents, if any

1. Equipment Installation Qualification (IQ) Protocol
2. Equipment Operational Qualification (OQ) Protocol
3. Equipment Performance Qualification (PQ) Protocol
4. Requalification Schedule and Records

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
International Conference on Harmonization (ICH) guidelines
Equipment manufacturer’s specifications and manuals

8) SOP Version

Version 1.0