Pharmaceutical Equipment GMP Audit Check list

By: Pharma Tips | Views: 6769 | Date: 15-May-2015

List of the points to be checked for GMP audit regarding equipment in pharmaceutical.

Pharmaceutical Equipment GMP Audit Check list

List of the points to be checked for GMP audit regarding equipment in pharmaceutical.

GMP Audit for Equipment in Pharmaceutical Industry

1. 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?

2. Are the equipment of appropriate design, construction and adequate size suitably located? 

3. Are the equipment surfaces coming into contact with any raw material, intermediate bulk or finished product made of inert materials (e.g. stainless steel) 

4. Are the equipment properly maintained and easily cleaned? 

5. Are there procedures for cleaning and maintenance available? (Indicate responsibility, contractual details, maintenance routines which could affect product quality) 

6. Are all equipment for cleaning and maintenance recorded? (Indicate type, frequency, details of reports/modification, use of report) 

7. Are all equipment properly grounded where required? 

8. Is there any program for calibration of measuring equipment? 

9. Is the result of the calibration documented? 

10. Are all open mechanical belts, pulley, etc equipped with safety guards? 

11. Are major equipment clearly marked with identifying numbers? 

12. 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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Nemu  |  10-Feb-2019 16:53:22 IST
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