Principle. Premises must be located, designed, constructed, adapted and maintained to suit the operations to be carried out.
General
The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid crosscontamination, build-up of dust or dirt, and in general, any adverse effect on the quality of products.
Where dust is generated (e.g. during sampling, weighing, mixing and processing operations, or packaging of powder), measures should be
taken to avoid cross-contamination and facilitate cleaning.
Premises should be situated in an environment that, when considered together with measures to protect the manufacturing process, presents
minimum risk of causing any contamination of materials or products.
Premises used for the manufacture of finished products should be suitably designed and constructed to facilitate good sanitation.
Premises should be carefully maintained, and it should be ensured that repair and maintenance operations do not present any hazard to the quality of products.
Premises should be cleaned and, where applicable, disinfected according to detailed written procedures. Records should be maintained.
Electrical supply, lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or
indirectly, either the pharmaceutical products during their manufacture and storage, or the accurate functioning of equipment.
Premises should be designed and equipped so as to afford maximum protection against the entry of insects, birds or other animals. There should
be a procedure for rodent and pest control.
Premises should be designed to ensure the logical flow of materials and personnel.
