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October 9, 2026
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Products for human consumption require a level of care, requirements to meet and supervision to carry out very high because they could potentially be dangerous to the health of consumers. Today we focus specifically on the pharmaceutical sector. No one escapes that drugs must be subject to extremely high quality and safety standards in order to be taken by people. The FDA is the body in charge of carrying out this control. We tell you everything you need to know about the FDA.
The GMP regulations set out a series of standards and guidelines to be followed by manufacturers, in order to guarantee the quality and safety of the products made. In this way, The GMPs (Good Manufacturing Practice), also known as Good Manufacturing Practices (BPF) or Correct Manufacturing Standards (NCF), apply to the manufacture of foods, drugs, cosmetics, medical products and drugs.
These standards are essential for all sectors dedicated to the production of articles that are going to be used or consumed by the general public, since were created to achieve uniformity and control of manufacture according to the use that will be given to said products. We are talking about products that must be suitable for consumption or use because, if there are no regulations that establish standards that must be complied with in their manufacture, they could be a potential danger for consumers. Thus, they are applied both in large-scale sales processes, as in the supply of hospitals and in all clinical tests as a form of protection for final consumers and, sometimes, also for workers of the companies.
the GMP standards They were created in the United States after a whole series of problems and irregularities were detected in the manufacture of medicines and other processes of the pharmaceutical industry. In this way, the need arose to have a series of rules or standards that would guarantee that these products were manufactured in such a way that their consumption was safe for the public. Thus the GMPs arose.
the FDA (d)Food and Drug Administration) then began to impose quality controls and other audit processes for this type of product from the 1960s. And, later, This culminated in the implementation of GMP standards as we now know them in all kinds of sectors. For this reason, we continue to know this series of rules such as GMPS, its acronym in English, instead of as NCF (which would be the most correct in Spain).
But, the GMP regulations are not exclusive to the production of consumer goods. They are also subject, for example, laboratories to GMP standards, as well as clean rooms and other facilities like that. When applying GMP standards to a laboratory, It is about guaranteeing that the processes that are carried out within this installation are carried out in compliance with a minimum of security, so that the final result of these processes does not have a negative impact on the end user or those who are using the facilities.
Specifically, environments of this type according to the GMP must meet the following requirements:
there are legislation that regulate the application of some of these practices. In Europe, for example, they are regulated by the European Regulation 852/2004 and the European Regulation 853/2004.
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But who is in charge of regulation of imports food products, medicines, cosmetics, medical equipment and Other biological products and derivatives?
At this point, you may have already heard of this organism but, What is the FDA exactly?. Well, the FDA (in English it stands for ‘Food and Drug Administration’) is the body in charge of ‘Monitor and ensure the health of consumers through the review and surveillance of medicines for human and veterinary use, vaccines and other biological products, medical devices, food supply, cosmetics, dietary products and those that emit radiation”.
The role of the FDA is Certify that the medicines produced in laboratories are suitable for use without danger by the general public. However, this body is American and, therefore, the FDA responds to the US government, its 50 states, in addition to the District of Columbia, Puerto Rico, Guama, the Virgin Islands, American Samoa and other US territories and possessions, as reported the Official page of the organization.
Once what the FDA is established, let’s see what this body is for. The Food and Drug Administration certification attests that this institution considers that a drug meets all its standards quality and safety. According to the FDA, these are their main responsibilities for the user:
In this way, if we look at the specific definition of What is the FDA, in principle only affects North American products. However, the FDA It also has an important role in the rest of the countries. due to the international trade of this type of product. That is to say, although the FDA is the creator of the GMP and its regulations, it does not have a real power in Spain, however, beyond its borders, the FDA and its regulations affect all exports that we want to make to the United States from Spain.. complying with it will be a condition sine qua non In order to access the US market and to a large number of markets that are also governed by this demanding regulation.
In any case, both in terms of laboratories and the regulations applicable to GMP environments, as well as the production of articles for consumption, it is essential to know the Regulations applicable to your sector If you want to avoid problems and ensure safety. Contact us if you have doubts and we will advise you without problem.
Yes, depending on the type of product and sector that we are talking about, there are a series of different standards and specifications that will have to be met to guarantee safety during the manufacturing process.
The equivalent in Spanish to GMPs is NCF or standards of correct manufacture, although, in Spain the denomination in English is usually used as much as the Spanish one or even more.
The acronym: FDA stands for Food and Drug Administration, which in Spanish could be translated as food and medicine administration.
Good Manufacturing Practices or good manufacturing practices are a series of rules and guidelines to be followed by manufacturing companies, to ensure that their products have quality and safety standards.
FDA certification means that the drug or product in question has complied with the safety standards and requirements that this body considers minimum so that the product is safe for consumption without running any type of risk.
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