Pharmacy Courses

GMP Audit Checklist for Pharmaceutical | WHO Guideline (Part-2)

The WHO GMP checklist for facilities and support system is given below:

General Facilities

  • Is the building used for manufacturing of product suitably located and constructed, and of adequate sizes to facilitate cleaning, maintenance and proper operation?
  • Are areas clearly defined and appropriately controlled? - For quarantine and storage of starting materials? For storage of in-process material? For manufacturing and processing operations? For control and laboratory operations? For quarantine and storage of finished products?bFor holding of rejected material? For ancillary usage, e.g. rest rooms, maintenance workshops? For animal housing?
  • Does the building design prevent the entry of insects, vermin and other animals?
  • Plumbing : Do adequate drains exist? Are they designed with an atmosphere break to prevent back-siphon age from sewer? Are traps being maintained to ensure  adequate performance?
  • Does the design of the facility achieve a  unidirectional flow of materials, personnel, product and waste so as to avoid crossover of clean and dirty (infectious) material?
  • Is the lighting provided adequate for the conditions necessary for the work being conducted in the area?
  • Are facility layout drawings including mechanical, electrical and architectural kept up-to date following changes? Is re validation of facilities performed following reimbursement?
  • Campaign production: Is the facility designed and constructed to permit production in campaigns? Has campaign changeover been validated (effectiveness of changeover)? Is there a documented procedure for changeover that described decontamination, removal of equipment, etc? Is there a campaigning schedule available?
  • Do washing facilities include: Hot and cold water? Soap and detergent? Clean toilet facilities that are easily accessible to working area? Clean hand drying facilities?
  • Are the premises satisfactory with respect to: Neatness and cleanliness, State of repair, e.g. paint work, cracks  in floors, ceiling or walls, door seals, etc? Exposed piping or electrical wiring? Blocking of air ducts? Equipment blocking corridors or exists?

Support Systems

Support systems, including those identified below:
  • Are they designed and validated to assure integrity of the characteristics of in-process material and final products?
  • Is there a planned maintenance program on each system? Is it followed?
  • Are there specs and written procedures for the operation of the systems, sampling plan, sites monitored and alert and action levels defined?
  • Are definitive action steps taken to resolve conditions that are out of specification?
  • Are pre-filters present in heating, ventilation and air-conditioning (HVAC) systems and replaced on a routine basis?
  • Are high-efficiency particulate air (HEPA) filters tested for integrity, at least annually?
  • Are HEPA filters terminally located?
  • Are ductwork materials impervious to disinfectants that may cause corrosion?
  • Are duct work and filters located outside the clean rooms?
  • If fumigation procedures are used, is the facility designed to permit effective fumigation?
  • Is the number of air changes per hour adequate for defined areas?
  • Is the air flow adequate? (Minimal pressure differential (1.21mm H2O) maintained?
  • Is room temperature and humidity effectively controlled?

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