General GMP requirements:

A new facility you need to be made as to what cGMP requirements will apply to the overall project and the specific products that are to be manufactured in that facility. These requirements may vary in different countries but there are general requirements that cover all the cGMPs worldwide. Common elements include guidelines regarding establishment of an effective quality system, ensuring that personnel are suitably trained and supervised, ensuring that facilities and equipment are located, designed, installed, operated and maintained to suit intended operations, and that standard operating procedures are in place to prevent contamination in the premises and cross contamination between products and even batches.

  • GMP design requirements:
  • Understanding the regulatory requirements for the products to be manufactured, the consultants must define the GMP requirements for a facility’s design and construction.
  • Facilities and environment:
  • These include buildings, rooms etc, in general the layout of areas must minimize the possibility of product mix-ups. The adequacy of the working and in-process storage space must also permit the orderly and logical positioning and separation of equipments and materials so as to minimize the risk of confusion between different medicinal products or their components.
  • Services and utilities:
  • Services and utilities that come into direct product contact are of particular concern when designing and constructing a new facility.
  • Personnel flow:
  • Personnel working in the manufacturing facility have direct influence on product quality. Airlocks are one means to control contamination necessary due to process or product requirements. Personnel airlocks may be necessary for connection of areas where dust generates.
  • Material flows:
  • In order to avoid cross contamination between different raw materials or finished products, when designing a new pharmaceutical facility, the type and amount of materials that are to be delivered to the manufacturing area must be one of the main considerations during designing of the facilities.
  • Equipment flows:
  • It is important to consider that not all equipment may be fixed permanently in one position; they may either be moved routinely as part of the production process or be capable of relocation for cleaning and sanitation or plant maintenance.
  • Validation master planning:
  • Validation Master Plan is a formal document that clearly describes the general philosophy, expectations, intentions and methods to be used for the validation of a facility and its equipment and processes.

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