Standard Operating Procedure for Equipment Qualification and Calibration in Ointment Formulation

1) Purpose

The purpose of this SOP is to outline the procedures for the qualification and calibration of equipment used in the formulation of ointments to ensure compliance with regulatory requirements and to guarantee the quality, safety, and efficacy of the final product.

2) Scope

This SOP applies to all equipment used in the ointment formulation process, including but not limited to mixers, homogenizers, filling machines, and temperature control units. It covers all stages of equipment qualification (Installation Qualification, Operational Qualification, and Performance Qualification) and routine calibration activities.

3) Responsibilities

– Quality Assurance (QA): Responsible for overseeing the qualification and calibration activities, reviewing documentation, and ensuring compliance with SOPs and regulatory standards.
– Engineering Department: Responsible for performing the qualification and calibration tasks, maintaining calibration records, and ensuring equipment is in proper working order.
– Production Department: Responsible for operating equipment in accordance with SOPs and reporting any issues or deviations to the QA and Engineering departments.

4) Procedure

1. Equipment Qualification:
1.1 Installation Qualification (IQ):
1.1.1 Verify that the equipment is installed according to manufacturer specifications.
1.1.2 Document installation details, including location, serial numbers, and utilities connections.
1.1.3 Confirm that all required manuals and documentation are available.
1.2 Operational Qualification (OQ):
1.2.1 Develop and execute OQ protocols to test equipment functionality under typical operating conditions.
1.2.2 Record operational parameters and compare them with manufacturer specifications.
1.2.3 Address any deviations and document corrective actions taken.

1.3 Performance Qualification (PQ):
1.3.1 Conduct PQ to ensure equipment consistently performs according to predefined criteria during actual production.
1.3.2 Use sample production runs to verify performance.
1.3.3 Document results and obtain QA approval.

Calibration:
2.1 Calibration Schedule:
2.1.1 Develop a calibration schedule for all equipment based on manufacturer recommendations and criticality of the equipment.
2.1.2 Maintain a log of calibration due dates and ensure timely calibration.

2.2 Calibration Procedures:
2.2.1 Use standard calibration methods and traceable standards.
2.2.2 Record calibration data, including any adjustments made.
2.2.3 Label equipment with calibration status (e.g., calibrated, due for calibration).

Documentation:
3.1 Maintain all qualification and calibration records in accordance with GMP documentation practices.
3.2 Ensure records are easily retrievable for audits and inspections.

5) Abbreviations, if any

– IQ: Installation Qualification
– OQ: Operational Qualification
– PQ: Performance Qualification
– QA: Quality Assurance
– GMP: Good Manufacturing Practice

6) Documents, if any

– Equipment manuals
– Qualification protocols (IQ, OQ, PQ)
– Calibration records and certificates
– SOPs for equipment operation and maintenance

7) Reference, if any

– FDA Guidelines for Process Validation
– EU GMP Annex 15: Qualification and Validation
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0