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