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Good manufacturing practice (GMP) & Good distribution practice (GDP)

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Nitin Mehta
Good manufacturing practice (GMP) & Good distribution practice (GDP)

Good manufacturing practice (GMP)

Good manufacturing practice (GMP) is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices.

GMP Certification confirms the product's identity, composition, quality, purity and strength which they represent in the market. Under it, there is a set of guidelines that offer a system of procedures and documentation by which the confirmation of the products is given.


Benefits from GMP:

  • Reduced duplication of inspections
  • Enhanced market access
  • Export facilitation
  • Cost savings
  • Customers, employees, stockholders, regulators and competitors develop sustainable respect for an organization which demonstrates its proactive commitment to food safety.


Cosmetics — Good Manufacturing Practices (cGMP)

ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products.

These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment.

The guidelines in ISO 22716:2007 are not applicable to research and development activities and the distribution of finished products.


Good distribution practice (GDP)

Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines are maintained throughout the supply chain.


Compliance with GDP ensures that:

  • medicines in the supply chain are authorised in accordance with European Union (EU) legislation;
  • medicines are stored in the right conditions at all times, including during transportation;
  • contamination by or of other products is avoided;
  • an adequate turnover of stored medicines takes place;
  • the right products reach the right addressee within a satisfactory time period.


The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure.


GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of medicines.



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