GMP Audit Check List- Equipment
List of the points to be checked for GMP audit regarding equipment in pharmaceutical.
- Is brief description of major production and quality control lab. Equipment indicating construction, validation and suitability of other materials (polypropylene, chrome plated brass, PVC, non-reactive plastic materials) provided?
- Are the equipment of appropriate design, construction and adequate size suitably located?
- Are the equipment surfaces coming into contact with any raw material, intermediate bulk or finished product made of inert materials (e.g. stainless steel).
- Are the equipment properly maintained and easily cleaned?
- Are there procedures for cleaning and maintenance available? (Indicate responsibility, contractual details, maintenance routines which could affect product quality)
- Are all equipment for cleaning and maintenance recorded? (Indicate type, frequency, details of reports/modification, use of report)
- Is the result of the calibration documented?
- Are all open mechanical belts, pulley, etc equipped with safety guards?
- Are major equipment clearly marked with identifying numbers?
- Are qualification, validation and calibration programs available for equipment used for production, quality control heating ventilation, air conditioning (HVAC), water system, steam, compressed air, gasses etc.?( indicate policy/protocols for qualification and validation, revalidation, calibration and their recording)
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