GMP Audit Checklist Personnel and Premises

Personnel

• Is proper job description available for key personnel and the number of employees to take along with proper qualification, experience?
• Do the new employees have on the job training?
• Are sufficient personnel available for supervising the assigned function in various departments as production, maintenance, QA, QC, filling and labeling and packaging?
• Are personnel from various departments trained or skilled in various fields like biology, chemistry, microbiology, veterinary and industrial engineering?
• Do the personnel have proper training for handling used pathogenic agents and method for using containment equipment?
• Are separate procedures available for various areas in handling animals, microorganisms and product?
• Are the current training and education records available and are they filed with supervisor?
• Does a GMP training programme exist for new employees?
• Is there an annual update for all the staff? Are records maintained?
• Are protective apparel provided?
• Is there any SOP for gowning procedures for the staff in the production?
• Are 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?
• Are there any procedures for preventing entry into production, storage, quality control and animal areas?
• Are there proper washing facilities with hot and cold water, soap and detergent?
• Are proper cleaning toilet and hand drying facilities available?

Premises

• Are the premises maintained with proper neatness and cleanliness?
• Do the premises have any repairs in regard to paint work or cracks on floors, walls or ceiling or door seals?
• Is any piping or electric wiring exposed?
• Are there any equipment’s with blocking corridors or exists?
• Is proper control followed in cleaning, maintenance and environment of premises?
• Are proper specifications given for preventing contamination and cross contamination in the premises?
• Is proper place provided to allow logical and orderly placement of materials, equipment’s and also allows proper movement of personnel?
• Is there a proper control system to restrict rodents, insects, birds and pests?
• Are proper measures taken to permit easy cleaning of walls, floors and ceilings?
• Are the premises intended for production well lighted who proper ventilation and air control facilities?
• Are proper air handling systems available in production, QC and packing areas?
• Are proper drainage systems available for preventing back flow and entry of rodents, insects into premises?
• Are areas segregated in order to handle production of sensitive pharmaceutical products like Beta lactams, cytotoxic substances, and penicillin’s and biological preparations like microorganisms?

Personnel, premises, training, gmp audit checklist

• mcrhrdi.gov.in
• cdsco.nic.in