Quality and safety are two attributes that the industry must guarantee to ensure consumer care and satisfaction. The way to achieve them lies not only in assessing consumer needs and expectations but also in the strict compliance with specific guidelines regarding hygiene, handling, packaging, and product distribution. The GMP regulation makes this possible.
The following explains what this regulation consists of, the sectors in which it is critical, its importance, and, of course, its key components.
The focus of this regulation is to provide a set of minimum guidelines for ensuring quality and safety in manufacturing or production across various industries. In English, it is known as Good Manufacturing Practices —hence the acronym GMP—while in Spanish it is called Normas de Correcta Fabricación (NCF).
Although it focuses on production processes, it also guides the application of appropriate practices in storage (conditions, inventory) and distribution (dispatch). At all times, the goal is to comply with internal and external standards (see the corresponding certifications) concerning the suitability of products for use.
Accordingly, the GMP regulation applies from the receipt of raw materials to the execution of manufacturing operations, where the production chain is under constant supervision. Since these products are intended for consumption, they must undergo a rigorous control process as part of the regulatory compliance required in sectors such as food, pharmaceuticals, and cosmetics.
The GMP regulation is oriented toward at least three major industries where it is essential to guarantee quality and safety standards according to product characteristics and uses—mainly for consumption as food or part of medical treatments. Below are the application areas of these guidelines:
This industry follows strict regulations since it deals with biological products and the development of medicines that must be safe for consumers. In this sense, the application of GMP focuses on the proper selection of raw materials, handling of inputs, production, and packaging (i.e., batches). Preventing contamination or errors is currently essential.
The cosmetic industry, like the pharmaceutical one, applies GMP in the production of products mainly intended for skin application. This ensures that such products do not cause consumer issues (e.g., allergic reactions, severe damage, poisoning), and that they undergo a meticulous batch control, which is critical for product traceability. In this case, if any defect or issue is detected, the products can be promptly withdrawn.
The food industry must also be mentioned, where handling, processing, packaging, and distribution protocols are as rigorous as in other sectors. Here, hygiene is crucial, but so is product preservation to prevent the proliferation of bacteria and, in any case, batch contamination. The food industry is primarily concerned with ensuring public health.
In all these cases, Good Manufacturing Practices (GMP)—also known as Good Manufacturing Practices (GMP)—and Good Hygiene Practices are followed. They are regulated by national agencies, such as the Spanish Agency for Medicines and Health Products (AEMPS), and international entities such as the European Union and its Good Manufacturing Guidelines (GMP Guide).
These are the aspects that explain the importance of this regulation:
GMP standards focus on seven key aspects that guide both production and product distribution. Below are the main components of these standards.
In GMP regulations, qualified personnel are essential. That is, employees involved in the manufacturing process must not only have industry-related training but also receive continuous education to understand, apply, and evaluate their own work in relation to the applicable standards. Additionally, there must be a clear structure in the production chain that identifies all operators and supervisors involved at each stage.
Facilities must be adapted or built specifically for the industry to which they belong. This is essential to meet high standards of hygiene, design, climate control, and work area delimitation, among others, to prevent any type of contamination. Furthermore, the equipment installed in these areas must be suitable for the production process and receive regular maintenance. This is important not only for operational efficiency but also to reduce errors or failures in final products.
These three stages—production, storage, and distribution—must be documented. Why is this important in GMP regulation? Because according to current regulations, products must be properly labeled and assigned a batch number. As part of traceability, this information makes it possible to know the conditions under which products were manufactured, handled, and stored, which may provide clues about errors, contamination, or degradation.
Following the previous point, documentation is essential in GMP procedures. All processes—even distribution—must be recorded in detail and accurately. Thus, if a health alert were received, manufacturers or distributors could act quickly to withdraw specific batches from the market and halt production to prevent further issues.
Quality controls are essential to ensure that products meet industry-specific specifications and regulatory requirements. What aspects are verified? Physical, chemical, and microbiological tests are carried out at different stages of the manufacturing process, and random final product samples are taken to confirm suitability. Production, packaging, laboratory staff, and other specialists—such as industrial and chemical engineers—are responsible for recording results and validating continued operations.
The GMP regulation requires regular internal and external inspections and audits. This is essential to identify possible noncompliance with standards, failures in safety and hygiene protocols, as well as poor equipment control (i.e., calibration, maintenance, replacement). Detecting areas for improvement enables the application of GMP standards and, in turn, ensures consumer protection.
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