Standard Operating Procedure for Equipment Qualification Protocols

1) Purpose

The purpose of this SOP is to outline procedures for the qualification of equipment used in the manufacturing of dental dosage forms, ensuring that equipment installations, operations, and performance meet specified requirements and regulatory standards.

2) Scope

This SOP applies to all equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for overseeing equipment qualification protocols. Engineering and technical personnel are responsible for executing qualification activities and ensuring compliance with documented procedures.

4) Procedure

4.1 Installation Qualification (IQ)

4.1.1 Verify that equipment is received as per specifications and that all components are present and in good condition.

4.1.2 Ensure that equipment is installed correctly according to manufacturer’s recommendations and site specifications.

4.2 Operational Qualification (OQ)

4.2.1 Verify and document that equipment operates according to predefined operational parameters and specifications.

4.2.2 Conduct tests to demonstrate that equipment functions as intended under operational conditions.

4.3 Performance Qualification (PQ)

4.3.1 Execute performance tests to demonstrate that equipment consistently produces results within specified limits over an extended period.

4.3.2 Document and review PQ results to ensure equipment performance meets acceptance criteria.

4.4 Requalification and Change Control

4.4.1 Schedule and conduct periodic requalification activities as per established timelines and change control procedures.

4.4.2 Initiate requalification following equipment modifications, upgrades, or significant changes to manufacturing processes.

4.5 Documentation and Reporting

4.5.1 Maintain comprehensive records of all qualification activities, including protocols, test results, deviations, and corrective actions.

4.5.2 Prepare qualification reports summarizing findings, conclusions, and recommendations for approval by QA.

5) Abbreviations, if any

SOP – Standard Operating Procedure

IQ – Installation Qualification

OQ – Operational Qualification

PQ – Performance Qualification

6) Documents, if any

Equipment Specifications

Qualification Protocols and Reports

Change Control Records

7) Reference, if any

International Conference on Harmonization (ICH) guidelines

Regulatory requirements for equipment qualification

8) SOP Version

Version 1.0