Audit checklist for who GMP guideline compliance in pharmaceuticals_Part 2

Design Control with respect to who gmp,not directly related to the Drug Regulation

• Facility Control Check here YES / NO
• Facility Design and Layout Check here YES / NO
• Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products? Check here YES / NO
• Is there sufficient space in the facility for the type of work and typical volume of production? Check here YES / NO
• Does the layout and organization of the facility prevent contamination? Check here YES / NO

Environmental Control Program for GMP compliance

• The facility is NOT situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations? Check here YES / NO
• Are grounds free of standing water? Check here YES / NO
• Is lighting adequate in all areas? Check here YES / NO
• Is adequate ventilation provided? Check here YES / NO
• Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products? Check here YES / NO
• If air filters are used, is there a written procedure specifying the frequency of inspection and replacement? Check here YES / NO
• Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility? Check here YES / NO
• Does the facility have separate air handling systems, if required, to prevent contamination? (MANDATORY IF PENICILLIN IS PRESENT!) Check here YES / NO

Facility Maintenance and Good Housekeeping Program for GMP

• Is this facility free from infestation by rodents, birds, insects and vermin? Check here YES / NO
• Does this facility have written procedures for the safe use of suitable, (e.g. those that are properly registered) rodenticides, insecticides, fungicides, and fumigating agents? Check here YES / NO
• Is this facility maintained in a clean and sanitary condition? Check here YES / NO
• Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods, equipment and material? with respect to who gmp guide for quality assuarance
• Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents? with respect to who gmp guide for quality assuarance, Check here YES / NO
• Are all parts of the facility maintained in a good state of repair ?
• Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?) Check here YES / NO

Outside Contractor Control Program

• Are contractors and temporary employees required to perform their work under sanitary conditions? with respect to who gmp guide for quality assuarance. Check here YES / NO
• Are contractors qualified by experience or training to perform tasks that may influence the production, packaging, or holding of drug products? Check here YES / NO

 Equipment Control with respect to who gmp

• Equipment Design and Placement Check here YES / NO
• Is all equipment used to manufacture, process or hold a drug product of appropriate design and size for its intended use? Check here YES / NO
• Are the following pieces of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Are the following pieces of equipment suitable in their size/capacity? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Are the following pieces of equipment suitable in their design? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Are the locations in the facility of the following pieces of equipment acceptable? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Are the following pieces of equipment properly installed? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Is there adequate space for the following pieces of equipment? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify),for GMP Check here YES / NO
• Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive, and non-additive so as not to affect the product? Check here YES / NO
• Are design and operating precautions taken to ensure that lubricants or coolants or other operating substances do NOT come into contact with drug components or finished product? Check here YES / NO
• Fiber-releasing filters are NOT used in the production of injectable products? Check here YES / NO
• Asbestos filters are NOT used in the production of products, with respect to who gmp guide for quality assuarance? YES / NO
• Is each idle piece of equipment clearly marked "needs cleaning" or "cleaned; ready for service"? Check here YES / NO
• Is equipment cleaned promptly after use? YES / NO Check here YES / NO
• Is idle equipment stored in a designated area? Check here YES / NO
• Are written procedures available for each piece of equipment used in the manufacturing, processing or holding of components, in-process material or finished product? Check here YES / NO
• Do cleaning instructions include disassembly and drainage procedure, if required, to ensure that no cleaning solution or rinse remains in the equipment? Check here YES / NO
• Does the cleaning procedure or startup procedure ensure that the equipment is systematically and thoroughly cleaned? Check here YES / NO

Reference : WHO guideline for GMP/Internet