Standard Operating Procedure for Calibration of Equipment Used for Lotions

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the calibration of equipment used in the manufacturing and testing of lotions to ensure accurate and reliable measurements.

2) Scope

This SOP applies to all personnel responsible for the calibration of equipment used for lotions within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Quality Control (QC) Personnel:

• Perform calibration of equipment according to this SOP and ensure compliance with calibration schedules.
• Maintain calibration records and documentation.

Quality Assurance (QA) Personnel:

• Review and approve calibration procedures and records.
• Ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Calibration Schedule:

• Establish a calibration schedule for all equipment used in the production and testing of lotions based on manufacturer recommendations and regulatory requirements.
• Ensure that critical equipment is calibrated more frequently and in accordance with defined procedures.

4.2 Calibration Process:

1. Preparation:
   • Gather calibration standards and tools required for the specific equipment.
   • Review the equipment manufacturer’s instructions and calibration procedures.
2. Perform Calibration:
   • Follow the step-by-step calibration procedure as outlined in the equipment manual or calibration SOP.
   • Adjust and calibrate equipment settings as necessary to ensure accuracy and reliability.
3. Verification:
   • Perform verification tests to confirm that the equipment meets specified accuracy and performance criteria.
   • Document calibration results, including any adjustments made during the calibration process.
4. Post-Calibration Activities:
   • Label calibrated equipment with calibration date, next due date, and initials of personnel performing the calibration.
   • Update calibration records and maintenance logs promptly.

4.3 Out-of-Tolerance Conditions:

• If equipment fails calibration, label it as “out of calibration” and remove it from service until recalibration is performed.
• Investigate and document any deviations from calibration specifications.

4.4 Documentation:

• Maintain accurate and complete calibration records, including calibration certificates, equipment logs, and verification reports.
• Ensure all calibration documentation is readily accessible for review by authorized personnel and regulatory inspectors.

5) Abbreviations, if any

SOP: Standard Operating Procedure

QC: Quality Control

QA: Quality Assurance

6) Documents, if any

• Calibration Records
• Equipment Maintenance Log
• Calibration Certificates

7) Reference, if any

• ISO <9001>: Quality management systems – Requirements
• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0