Guidelines for Instrument Calibration in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the calibration of instruments to ensure the accuracy and reliability of measurements in the manufacturing of vaginal dosage forms.

2) Scope

This SOP applies to all instruments and equipment used in the manufacturing, testing, and packaging of vaginal dosage forms within the pharmaceutical facility.

3) Responsibilities

It is the responsibility of the Quality Assurance, Maintenance, and Production departments to implement and follow this SOP to ensure compliance with calibration requirements.

4) Procedure

4.1 Calibration Schedule

1. Develop a calibration schedule for all instruments and equipment based on manufacturer recommendations and regulatory requirements.
2. Ensure the calibration schedule is documented and maintained in a calibration log.

4.2 Selection of Calibration Standards

1. Select calibration standards that are traceable to national or international standards.
2. Document the source and traceability of calibration standards used.

4.3 Calibration Procedures

1. Develop and document detailed calibration procedures for each instrument and equipment.
2. Ensure calibration procedures include steps for pre-calibration checks, calibration, and post-calibration checks.
3. Use validated methods and certified calibration standards for calibration activities.

4.4 Execution of Calibration

1. Perform calibration activities according to the documented procedures and schedule.
2. Record calibration data, including the date, instrument identification, calibration standard, and calibration results.

4.5 Acceptance Criteria

1. Establish acceptance criteria for calibration based on instrument specifications and regulatory guidelines.
2. Ensure acceptance criteria are documented in the calibration procedures.

4.6 Handling of Out-of-Tolerance Instruments

1. Identify and quarantine instruments that fail to meet calibration acceptance criteria.
2. Investigate and document the root cause of calibration failures and take corrective actions.
3. Recalibrate instruments after corrective actions are implemented.

4.7 Calibration Records

1. Maintain calibration records, including calibration certificates, calibration logs, and calibration reports.
2. Ensure calibration records are reviewed and approved by the Quality Assurance department.

4.8 Recalibration

1. Perform recalibration periodically or when there are significant changes to the instrument or its usage.
2. Document and review recalibration activities to ensure ongoing compliance.

5) Abbreviations, if any

N/A

6) Documents, if any

Calibration schedule, calibration procedures, calibration logs, calibration certificates

7) Reference, if any

FDA Guidance for Industry: Calibration of Instruments, EU GMP Annex 11: Computerised Systems, ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0