Production Areas and Quality Control Areas


Production Areas and Quality Control Areas

Production Areas:

12.24   In order to minimize the risk of a serious medical hazard due to cross-contamination, dedicated and self-contained facilities must be available for the production of particular pharmaceutical products, such as highly sensitizing materials (e.g. penicillins) or biological preparations (e.g. live microorganisms). The production of certain other highly active products, such as some antibiotics, hormones, cytotoxic substances and certain non-pharmaceutical products, should not be conducted in the same facilities. In exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations (including cleaning validation) are made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of pharmaceutical products.

12.25   Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels.

12.26   The adequacy of the working and in-process storage space should permit the orderly and logical positioning of equipment and materials so as to minimize the risk of confusion between different pharmaceutical products or their components, to avoid cross-contamination, and to minimize the risk of omission or wrong application of any of the manufacturing or control steps.

12.27   Where starting and primary packaging materials and intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors and ceilings) should be smooth and free from cracks and open joints, should not shed particulate matter, and should permit easy and effective cleaning and, if necessary, disinfection.

12.28   Pipework, light fittings, ventilation points and other services should be designed and sited to avoid the creation of recesses that are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas.

12.29   Drains should be of adequate size and designed and equipped to prevent back-flow. Open channels should be avoided where possible, but if they are necessary they should be shallow to facilitate cleaning and disinfection.

12.30   Production areas should be effectively ventilated, with air-control facilities (including filtration of air to a sufficient level to prevent contamination  and cross-contamination, as well as control of temperature and, where necessary, humidity) appropriate to the products handled, to the operations undertaken and to the external environment. These areas should be regularly monitored during both production and non-production periods to ensure compliance with their design specifications.

12.31   Premises for the packaging of pharmaceutical products should be specifically designed and laid out so as to avoid mix ups, contamination or cross-contamination.

12.32   Production areas should be well lit, particularly where visual online controls are carried out.

Quality Control Areas:

12.33   QC laboratories should be separated from production areas. Areas where biological, microbiological or radioisotope test methods are employed should be separated from each other.

12.34   QC laboratories should be designed to suit the operations to be carried out in them. Sufficient space should be given to avoid mix ups and cross-contamination. There should be adequate suitable storage space for samples, reference standards (if necessary, with cooling), solvents, reagents and records.

12.35   The design of the laboratories should take into account the suitability of construction materials, prevention of fumes, and ventilation. There should be separate air supply to laboratories and production areas. Separate air-handling units and other provisions are needed for biological, microbiological and radioisotope laboratories.

12.36   A separate room may be needed for instruments to protect them against electrical interference, vibration, contact with excessive moisture and other external factors, or where it is necessary to isolate the instruments.

WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles

(Annex 2, WHO Technical Report Series 986, 2014)

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