GMP Audit Checklist For Drug Manufacturers page 3

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GMP Audit Checklist Page 3
Question Instructions/questions (note any exceptions and comments in notebook). Yes, No, or NA
2.0 Design Control   
  Not directly related to 21 CFR Parts 210 and 211  
3.0 Facility Control
3.1 Facility Design and Layout
3.101 §211.42(a) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products?  
3.102 §211.42(b) Is there sufficient space in the facility for the type of work and typical volume of production?  
3.103 Does the layout and organization of the facility prevent contamination?  

 

3.2 Environmental Control Program  
3.201 The facility is NOT situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations?  
3.202 Are grounds free of standing water?  
3.203 §211.44 Is lighting adequate in all areas?  
3.204 §211.46 Is adequate ventilation provided?  
3.205 §211.46 Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products?  
3.206 §211.46 If air filters are used, is there a written procedure specifying the frequency of inspection and replacement?  
3.207 Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility?  
3.208 §211.42(d) Does the facility have separate air handling systems, if required, to prevent contamination? (MANDATORY IF PENICILLIN IS PRESENT!)  

 

3.3 Facility Maintenance and Good Housekeeping Program  
3.301 §211.56(a) Is this facility free from infestation by rodents, birds, insects and vermin?  
3.302 §211.56(c) 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?  
3.303 Is this facility maintained in a clean and sanitary condition?  
3.304 Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods, equipment and material?  
3.305 Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents?  
3.306 §211.58 Are all parts of the facility maintained in a good state of repair?  
3.307 §211.52 Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?)  

 

3.4 Outside Contractor Control Program  
3.401 §211.56(d) Are contractors and temporary employees required to perform their work under sanitary conditions?  
3.402 ¶ 163 Are contractors qualified by experience or training to perform tasks that may influence the production, packaging, or holding of drug products?  

 

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Last Update: 19 August 2011

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