Standard Operating Procedure for Calibration of Equipment Used for Gels
1) Purpose
The purpose of this SOP is to outline procedures for the calibration of equipment used in the manufacturing and testing of gels to ensure accuracy, reliability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel responsible for the calibration of equipment used in gel production and testing within the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC) Supervisor: Oversee calibration procedures as per this SOP.
Calibration Technicians: Perform equipment calibration and maintain calibration records.
Production Operators: Assist in preparing equipment for calibration and provide support as needed.
4) Procedure
4.1 Equipment Identification
4.1.1 Identify and list all equipment requiring calibration (e.g., balances, pH meters, viscometers).
4.1.2 Assign unique identification numbers or labels to each equipment item.
4.2 Calibration Schedule
4.2.1 Establish a calibration schedule based on equipment criticality and usage frequency.
4.2.2 Ensure adherence to calibration intervals defined in equipment manufacturer’s recommendations or regulatory requirements.
4.3 Calibration Execution
4.3.1 Retrieve equipment for calibration from designated storage areas.
4.3.2 Perform calibration using calibrated standards and procedures specified in equipment manuals or SOPs.
4.3.3 Record calibration data including before and after adjustments, if any.
4.4 Calibration Records
4.4.1 Document calibration results, including calibration dates, personnel involved, and equipment condition.
4.4.2 Attach calibration labels or tags to equipment indicating next due date and calibration status.
4.5 Out-of-Tolerance Conditions
4.5.1 Identify and address any equipment that fails calibration or falls out of tolerance limits.
4.5.2 Initiate corrective actions, including equipment adjustment, repair, or replacement as necessary.
4.6 Documentation and Traceability
4.6.1 Maintain accurate calibration records in a centralized database or logbook.
4.6.2 Ensure traceability of calibration standards used and calibration certificates.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
– Calibration Certificates
– Equipment Calibration Logs
– SOP for Calibration of Equipment
7) Reference, if any
– ISO 9001: Quality management systems – Requirements
– FDA Guidance for Industry: Process Validation: General Principles and Practices
– Manufacturer’s instructions for equipment calibration and maintenance
8) SOP Version
Version 1.0