Premises - Ancillary Areas, Storage Areas and Weighing Areas
12. Premises:
12.1 Principle. Premises must be located, designed, constructed, adapted and maintained to suit the operations to be carried out.
General:
12.2 The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and in general, any adverse effect on the quality of products.
12.3 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.
12.4 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.
12.5 Premises used for the manufacture of finished products should be suitably designed and constructed to facilitate good sanitation.
12.6 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.
12.7 Premises should be cleaned and, where applicable, disinfected according to detailed written procedures. Records should be maintained.
12.8 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.
12.9 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.
12.10 Premises should be designed to ensure the logical flow of materials and personnel.
Ancillary Areas:
12.11 Rest and refreshment rooms should be separate from manufacturing and control areas.
12.12 Facilities for changing and storing clothes and for washing and toilet purposes should be easily accessible and appropriate for the number of users. Toilets should not communicate directly with production or storage areas.
12.13 Maintenance workshops should if possible be separated from production areas. Whenever parts and tools are stored in the production area, they should be kept in rooms or lockers reserved for that use.
12.14 Animal houses should be well isolated from other areas, with separate entrance (animal access) and air-handling facilities.
Storage Areas:
12.15 Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products with proper separation and segregation: starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.
12.16 Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean, dry, sufficiently lit and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, controlled, monitored and recorded where appropriate.
12.17 Receiving and dispatch bays should be separated and should protect materials and products from the weather. Receiving areas should be designed and equipped to allow containers of incoming materials to be cleaned, if necessary, before storage.
12.18 Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel. Any system replacing the physical quarantine should give equivalent security.
12.19 Segregation should be provided for the storage of rejected, recalled, or returned materials or products.
12.20 Highly active and radioactive materials, narcotics, other dangerous medicines, and substances presenting special risks of abuse, fire or explosion should be stored in safe and secure areas.
12.21 Printed packaging materials are considered critical to the conformity of the pharmaceutical product to its labelling and special attention should be paid to sampling and the safe and secure storage of these materials.
12.22 There should normally be a separate sampling area for starting materials. (If sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination.)
Weighing Areas:
12.23 The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas designed for that use, for example, with provisions for dust control. Such areas may be part of either storage or production areas.
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles
(Annex 2, WHO Technical Report Series 986, 2014)
