GMP Audit checklist Sanitization and Hygiene

Sanitization

• Is a detailed sanitization programme specific to equipment and various area given?
• Are proper SOPs and facilities available for sanitizing and maintaining equipment’s and supplies?
• Are the frequency to perform sanitization procedures defined?
• Are sanitizing agents validated and approved by Quality control for use?
• Are trash, sewage and refuge controlled and disposed in a safe, timely and sanitary manner?
• Are proper procedures written for sanitization?
• Is the responsibility assigned for sanitization?
• Are the sanitizing schedules, equipment, materials and methods detailed in the procedure?
• Is the effectiveness of the disinfectants and other sanitizing agents evaluated?
• Is the chronological record of sanitizing agents used?
• Are the procedures followed regularly and are the records maintained for the same?
• Are the equipment’s and utensils sanitized appropriately to prevent cross-contamination or malfunction?
• Are the floors, walls and ceilings able to withstand disinfecting reagents?

Hygiene

• Is protective apparel provided?
• Is there any SOP for gowning procedures for the staff in the production?
• Is the staff provided with necessary instructions to report on medical and health problems that may cause unwanted effects on the product?
• Is there any medical monitoring programme for the safety of product and staff?
• Is vaccination applicable for all employees and contractors?
• Are there any controlled entry requirements for production, testing and animal areas?

Sanitization, hygiene, sanitizing agents, disinfectants, gmp audit checklist

• mcrhrdi.gov.in
• cdsco.nic.in