Standard Operating Procedure Calibration and Verification of Thickness Sorter

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a comprehensive process for the calibration and verification of the Thickness Sorter. This critical equipment is used in the pharmaceutical manufacturing process to ensure accurate and reliable sorting of tablets based on their thickness. By adhering to this SOP, we aim to maintain the highest level of accuracy, consistency, and compliance with regulatory requirements in our tablet production.

Scope

This SOP applies to all personnel involved in the calibration and verification of the Thickness Sorter at [Pharmaceutical Company Name]. It covers the calibration of the equipment to ensure precise measurements and the verification process to confirm that the Thickness Sorter operates within acceptable performance limits. The SOP outlines the step-by-step procedure and documentation requirements to ensure the equipment’s reliability and accuracy throughout its usage.

Responsibilities

The successful execution of this SOP relies on the cooperation and commitment of the following personnel:

• Quality Assurance Department: Responsible for developing, reviewing, and approving this SOP. They shall also conduct periodic audits to ensure compliance and the effectiveness of the calibration and verification processes.
• Equipment Calibration Team: Responsible for performing the calibration of the Thickness Sorter as per the defined schedule and procedures.
• Quality Control Team: Responsible for conducting the verification tests and ensuring that the Thickness Sorter meets the required performance criteria.
• Production Operators: Responsible for cooperating with the calibration and verification team and assisting as necessary during the process.

Procedure

The following step-by-step procedure must be followed for the Calibration and Verification of the Thickness Sorter:

1. Calibration:
   • Refer to the manufacturer’s guidelines and documentation for the recommended calibration procedure.
   • Ensure that the Thickness Sorter is powered off before initiating the calibration process.
   • Verify the calibration equipment’s accuracy and calibration standards before commencing the calibration.
   • Perform the calibration according to the prescribed parameters, adjusting the equipment as necessary to achieve accurate readings.
   • Record all calibration data, including pre-calibration and post-calibration measurements, in the calibration logbook.
   • Once the calibration is completed, affix a calibration label with the calibration date and the initials of the person performing the calibration.
2. Verification:
   • Ensure that the Thickness Sorter is powered off and disconnected from the power source before starting the verification process.
   • Set up the verification test using standardized test tablets or certified reference materials with known thickness values.
   • Run the verification test, and record the readings obtained from the Thickness Sorter for each test tablet.
   • Compare the results with the expected values based on the known thickness of the test tablets.
   • Calculate the deviation between the measured values and the expected values to determine the equipment’s accuracy.
   • Document the verification results in the verification logbook.
3. Final Evaluation:
   • Review the calibration and verification data to ensure that the Thickness Sorter meets the required performance criteria.
   • If any deviations are identified during the calibration or verification, investigate the root cause, and take appropriate corrective actions before proceeding further.
   • Once all the data is thoroughly reviewed and deemed acceptable, update the equipment records and affix the verification label with the verification date and the initials of the person conducting the verification.

Abbreviations

No abbreviations are used in this SOP.

Documents

The following documents are referenced in this SOP:

• Thickness Sorter Manufacturer’s Guidelines and Documentation
• Calibration Logbook
• Verification Logbook

Reference

No external references are used in this SOP.

SOP Version

This is version 1.0 of the SOP for Calibration and Verification of Thickness Sorter, issued on [Date of Issue].