Standard Operating Procedure for Calibration of Equipment in Ointment Formulation

1) Purpose

The purpose of this SOP is to establish procedures for the calibration of equipment used in ointment formulation to ensure accuracy, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all equipment and instruments used in the ointment formulation process that require calibration to maintain product quality and consistency.

3) Responsibilities

– Quality Assurance (QA): Responsible for overseeing the calibration program and ensuring compliance.
– Production Staff: Responsible for identifying equipment requiring calibration and scheduling calibration activities.
– Calibration Technicians: Responsible for performing calibration activities and maintaining calibration records.

4) Procedure

1. Equipment Identification:
1.1 Calibration Schedule:
1.1.1 Maintain a list of all equipment requiring calibration and their calibration schedules.
1.1.2 Include equipment identification, location, and calibration frequency.

1.2 Prioritization:
1.2.1 Prioritize equipment based on criticality to product quality and regulatory requirements.
1.2.2 Ensure equipment used for critical measurements is calibrated more frequently.

2. Calibration Process:
2.1 Preparation:
2.1.1 Gather calibration standards and tools required for the calibration procedure.
2.1.2 Check environmental conditions (e.g., temperature, humidity) are suitable for calibration.

2.2 Execution:
2.2.1 Perform calibration according to manufacturer’s instructions or approved procedures.
2.2.2 Record all measurements and adjustments made during the calibration process.

3. Documentation and Traceability:
3.1 Calibration Records:
3.1.1 Document calibration activities, including before and after calibration readings.
3.1.2 Record technician signatures and date of calibration.

3.2 Traceability:
3.2.1 Ensure calibration records include traceability to national or international standards (e.g., NIST).
3.2.2 Maintain records of calibration certificates and calibration due dates.

4. Out-of-Tolerance Conditions:
4.1 Investigation:
4.1.1 Investigate any equipment that falls out of calibration tolerance limits.
4.1.2 Implement corrective actions to address deviations and prevent recurrence.

4.2 Notification:
4.2.1 Notify QA and relevant stakeholders of out-of-tolerance equipment and actions taken.
4.2.2 Evaluate impact on product quality and determine if re-calibration or equipment adjustment is required.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– NIST: National Institute of Standards and Technology

6) Documents, if any

– Equipment Calibration Logs
– Calibration Certificates

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ISO 9001:2015 Quality management systems – Requirements

8) SOP Version

Version 1.0