why and how to get the GMP Certification

certification GMP (d)Good Manufacturing Practices) It is an authorization that health agencies grant to companies to be able to manufacture medicines, cosmetics and medical devices. This certificate can also be obtained by other suppliers such as active substance manufacturers.

In Spain, this GMP certification is granted by the Spanish Agency for Medicines and Health Products (AEMPS).

To obtain the GMP certification, it is necessary to submit an application to the regulatory agency, in this case the AEMPS. This application must be accompanied by a Technical memory o Prequalification file, which reflects compliance with the GMP regulations. The presentation of this usually takes half a month and consists of two audit stages:

1. The site facilities, in which the auditors will visit the place of manufacture for 3-5 days.
2. The product, for this the auditors will examine samples of the production lots.

These stages must be collected in the report in accordance with the good manufacturing practices or GMP of the European Union.

The cost of certification It is given by the realization of the technical memory, whose costs are very high and have a long compliance process, between one and two months. must also be paid Fees to the regulatory agency, established by the regulatory institution itself.

In addition to the costly and long process, pharmaceutical manufacturers must go through an annual audit to comply with management systems and regulations. This audit process depends on each country, since they can be required every year or every two.

His non-compliance would lead to the suspension of operations manufacturer’s commercial and/or Cancellation of registration. The need for such recurring audits is relative, since they are pharmaceutical products, which can impact people’s lives.

It is evident that manufacturers of pharmaceuticals, both in medicines and even in the manufacture of White rooms, must comply with GMP standards to meet government requirements. Even laws in some countries require compliance, even if GMP (Good Manufacturing Practices) or GMP are not applied.

According to the European Medicines Agency (EMA), for example, the drug should have the active ingredients that are marked on the label in addition to not be contaminated by other substances. This is a problem for those companies in the emerging markets, in which all active products are not always guaranteed.

In these cases, the EMA suggests that the problem can be solved by Ensure compliance with good manufacturing practice standards or GMP regulations. That is why more than one agency makes GMP certification the most important validation criterion for drugs.

click here To learn more about GMP regulations and their main requirements.