The GMP (Good Manufacturing Practices) or NCF (Correct Manufacturing Standards) –with the English acronym GMP (Good Manufacturing Practice) – are the standards that regulate the development of cosmetics, food, drugs, medical products and medicines in their final presentations. These Good Manufacturing Practices were elaborated by the Codex Alimentarius with the purpose of protecting the client, being subsequently established by the Spanish Agency for Medicines and Sanitary Products (AEMPS).

The GMP regulations for manufacturing apply within the quality guarantees and are part of the factors that ensure that all products are made in a controlled manner, respecting the established norms and appropriate to the use that will be given to the packaging.

Thanks to the application of GMP regulations for manufacturing, the quality of medicines is ensured, preventing them from becoming contaminated. GMP quality control requires that the company has the ability to fully cover the manufacturing process. In order to obtain the GMP certification, the company must demonstrate that it uses the appropriate equipment and facilities for making the packaging.

For everything to flow according to plan, the following requirements must be met:

  • Have qualified equipment and validated procedures.
  • Maintain complete and accessible records during the manufacturing process. This is the only way to verify that the operations have been carried out to the letter and that both the quality and quantity of the products are determined. In case of any deviation, a record must be made and an investigation carried out.
  • Take care that the procedures are written clearly and unequivocally. Similarly, these must be applied specifically to the means of production.
  • That the process of storage and distribution of products does not alter their quality.
  • Have the essential resources to manufacture the products.
  • Establishment of a product withdrawal system, either during the distribution or sale stage of the products.
  • Make a study of any claim filed against a product that has been marketed, in addition to investigating the causes of lack of quality, after which the necessary measures will be taken to prevent recurrence of defects.

Likewise, it must be verified that work is carried out according to the procedures established in all operations, which include the timeframe between placing orders for raw materials to the production, packaging, storage, transport, and delivery of products to wholesalers.

Even when GMP regulations for manufacturing seek a goal, each company establishes the rules that will be applied to achieve the objective, as well as the method by which it will demonstrate that the regulations are fully complied with.

If you are developing a new line of business, a product or want to value a potential change of packaging and material, at IP Triana we offer personalised advice. Get to know our complete offer.

 

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