General GMP facilities must be designed with the following minimum requirements:

  • The designated location of buildings and facilities must be appropriate to the processes performed and products handled.
  • The design must permit all necessary cleaning, maintenance and proper access to the process.
  • The design of the building and facility must conform to all Health & Safety internal and external requirements.
  • Design documents as a basis for design qualification of the facility (e.g. layout, environmental zoning concepts, room data sheets, etc.) must be provided and kept updated.
  • The design must ensure adequate lighting for the work being performed.
  • When required, environmental controls such as temperature and humidity of the production, testing and storage areas must be designed and maintained to ensure the quality of the products and/or materials as well as to ensure the reliability of the equipment.
  • There must be appropriate protection against the entry of pests.
  • The access to production areas must be limited to those working in these areas. There must be measures to prevent unauthorised access.
  • The number of drains must be limited. Where necessary they must be designed appropriately to the environmental zones where they are located.
  • The design must ensure the prevention of mix-up and cross-contamination by means of space, segregation, ventilation and logical workflow for materials and personnel.
  • Services (pipes, lights, etc.) must be designed to facilitate appropriate cleaning and maintenance.
  • Facility surfaces must be smooth, non-particulate shedding, free from cracks, and open joints in all areas where the quality of the products could be compromised and must not present risks of either microbiological or particulate contamination.
  • Facilities must be of a design suitable for their intended purpose. If Highly potent medicines are produced, additional protection measures are required.
  • Areas with restricted personnel access must be designed with features that facilitate the supervision of employees working within those areas.
  • Each facility must have appropriate waste disposal systems.
  • Special provisions, such as localised exhaust systems, must be used in areas where dust or fumes are generated.
  • Special provisions must be made for production, testing and storage of materials and products with special Health & Safety requirements (e.g. penicillins, cephalosporins, hormones, Highly Active Pharmaceuticals, and biologicals).
  • Equipment washing facilities must be suitably designed to ensure that the equipment can be cleaned, handled and stored in a manner that is appropriate for its use.


Designing Aseptic Area For GMP Manufacturing

Aseptic techniques are employed to provide protection to ophthalmic and parenteral products by preventing the entry of microbial and particulate contamination. 


Prevention of microbial contamination is also required to remove pyrogens and toxic bacterial products. Products are prepared under aseptic conditions using sterilised materials or are sterilised by filtration before being packed in sterile containers. Such aseptic products are formulated or prepared in an aseptic area, which is a room within a clean area designed, constructed, serviced, and used for controlling and preventing microbial contamination of the product.


The below guidance will provide information on the following topics -

  • Designing of aseptic area, Laminar flow equipment’s
  • Study of different sources of contamination in an aseptic area and methods of prevention
  • Clean area classification
  • Principles and methods of different microbiological assay
  • Methods for standardization of antibiotics, vitamins and amino acids
  • Assessment of a new antibiotic.


Those commissioned to build and install, must ensure they provide supporting documentation for the above GMP design requirements.


10 Golden Rules of GMP

1. Get the facility design right from the start

2. Validate processes

3. Write good procedures and follow them

4. Identify who does what

5. Keep good records

6. Train and develop staff

7. Practice good hygiene

8. Maintain facilities and equipment

9. Build quality into the whole product lifecycle

10. Perform regular audits


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