3.1 Are areas where pharmaceutical starting materials are handled designed and operated in a way to ensure cleanliness, appropriate hygiene and a minimisation of cross-contamination risks?
3.2 Are premises well constructed and in visibly good condition?
3.3 Are appropriate laboratory facilities available?
3.4 Has the site implemented security measures to control access of unauthorized persons?
3.5 Are the premises designed, operated, and maintained to avoid infestation by rodents, birds, insects, and other vermin?
3.6 Is there an effective pest control program in place?
3.7 Is the warehouse well ventilated?
3.8 If a heating/air-conditioning system is installed is it compatible with the stored products?
3.9 Is there adequate lighting in the warehouse?
3.10 Is the design and operation of the air handling system appropriate to avoid contamination and degradation of products?
3.11 Are the design, operation and maintenance of gas utility systems (e.g. nitrogen or compressed air) appropriate to avoid contamination of products?
3.12 If sampling is performed, are sampling areas arranged and procedures in place to prevent contamination and cross-contamination?
3.13 Is there a separate sampling area in a controlled environment?
3.14 Are cleaning procedures in place for sampling areas?
3.15 Are all samples taken and retained according to written procedures?
3.16 Are sampling procedures sufficient to ensure representative samples for quality control?
3.17 Are utensils and sampling devices cleaned and stored in a manner to prevent contamination?
3.18 Do sampling processes ensure sufficient protection of product quality?
3.19 Is it ensured that sampling installation is able to provide a representative sample?