Standard Operating Procedure for Calibration of Equipment Used for Granules

1) Purpose

The purpose of this SOP is to provide a standardized procedure for the calibration of equipment used in the manufacturing of granules in the pharmaceutical industry to ensure accurate and reliable performance.

2) Scope

This SOP applies to all personnel involved in the calibration of equipment used for granules within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control Analysts: Responsible for performing calibration activities as per the SOP.
Engineering Department: Responsible for maintaining calibration schedules and records.
Quality Assurance: Responsible for reviewing calibration results and ensuring compliance.

4) Procedure

1. Identification of Equipment:
   1. Identify all equipment used for granules that require calibration.
   2. Document equipment details including identification number and calibration frequency.
2. Calibration Schedule:
   1. Establish a calibration schedule based on manufacturer recommendations and regulatory requirements.
   2. Ensure calibration intervals are documented and adhered to.
3. Preparation for Calibration:
   1. Notify relevant personnel about upcoming calibration activities.
   2. Prepare calibration standards and equipment as per calibration procedures.
4. Calibration Process:
   1. Perform calibration procedures following documented instructions and using calibrated standards.
   2. Record calibration results accurately including deviations and adjustments made.
5. Verification:
   1. Verify the calibrated equipment against acceptance criteria and specifications.
   2. Ensure the equipment meets performance standards before returning to service.
6. Documentation:
   1. Complete calibration records including equipment details, calibration procedures used, and personnel involved.
   2. Ensure all documentation is reviewed, approved, and stored as per document control procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice

6) Documents, if any

Calibration SOP, Equipment Calibration Records

7) Reference, if any

International Conference on Harmonisation (ICH) guidelines and equipment manufacturer’s specifications.

8) SOP Version

Version 1.0