Below given details are the GMP requirements for the Pharmaceutical Plant premises or campus and Premises or campus must be located, designed, constructed, adapted and maintained to afford the Operations to be carried out.
General Requirements :
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.
Where dust is generated (e.g. during sifting, weighing, mixing and processing operations, or packaging of powder), measures should be taken to avoid cross-contamination and facilitate cleaning.
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 and 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 movement.
Additional Areas :
Rest and refreshment rooms should be separate from manufacturing and control areas.
Facilities for changing and storing clothes and for washing and toilet purposes should be easily accessible and appropriate for the number of users and Toilets should not communicate directly with production or storage areas.
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.
Storage Areas :
Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products with proper separation and segregation which includes starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.
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 & Relative humidity limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, controlled, monitored and recorded where appropriate.
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.
Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel.
Segregation should be provided for the storage of rejected, recalled, or returned materials or products.
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.
Printed packaging materials and similar looking packing materials are considered critical to the pharmaceutical product hence its labelling and special attention should be taken to safe and secure storage of these materials.
There should normally be a separate sampling area for starting materials. (If sampling is performed in the storage area, it should be conducted insuch a way as to prevent contamination or cross-contamination.)
Weighing Areas :
The weighing of raw material, intermediate, or a drug substance 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.
Production Areas :
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.
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.
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.
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 disinfection.
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.
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.
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 humidity where necessary) appropriate to the products handled. These areas should be regularly monitored during both production and non-production periods to ensure compliance with their design specifications.
Premises for the packaging of pharmaceutical products should be specifically designed and laid out so as to avoid mix ups, contamination or cross-contamination.
Production areas should be well lit, particularly where visual online controls are carried out.
Quality control Areas :
QC laboratories should be separated from production areas. Areas where biological, microbiological or radioisotope test methods are employed should be separated from each other.
QC laboratories should be designed to suit the operations to be carried out and 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.
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.
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.
Reference WHO Technical Report Series : TRS986annex2
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