Quality and safety are two attributes that the industry must guarantee for the care and satisfaction of consumers. The way to achieve them is found not only in the evaluation of their needs and expectations, but also in rigorous compliance with certain guidelines regarding hygiene, handling, packaging and distribution of products. The GMP regulations allow us to achieve this.
In what follows, we address what this regulation consists of, the sectors in which it is critical, its importance and, of course, the elements that make it up.
The focus of this regulation focuses on providing a set of minimum guidelines for ensuring quality and safety in manufacturing or production in various industries. In English, it is known as Good Manufacturing Practices – hence its acronym GMP – while in Spanish it is called Good Manufacturing Standards (NFC).
Although it focuses on production processes, it also guides the application of appropriate practices in storage (conditions, inventory) and distribution (dispatch). At all times, we seek to comply with internal and external standards (see the corresponding certifications) regarding the suitability of the products for their use.
Following this, the GMP regulations apply from the receipt of raw materials to the deployment of manufacturing operations, where the production chain is subject to constant supervision. The products, being consumer-oriented, must go through a rigorous control process, since this is part of compliance with regulations in sectors such as food, pharmaceutical and cosmetics.
The GMP regulations are aimed at, at least, three large industries in which it is essential to guarantee quality and safety standards according to the characteristics and uses of the products, that is, consumption as part of food or medical treatments. The fields of application of this group of guidelines are detailed below:
This industry follows strict regulations, as it works with biological products and in the development of medications that must be safe for the consumer. In this sense, the application of the GMP regulations is aimed at the appropriate choice of raw materials, handling of inputs, production and packaging (ie: batches). At this time, prevention of contamination or errors is essential.
The cosmetic industry, like the pharmaceutical industry, applies GMP regulations in the production of products whose application is fundamentally focused on the skin. Thus, it is ensured that these products do not cause problems in consumers (eg allergic reactions, severe damage, poisoning), in addition to meticulous batch control, which is critical for the traceability of the products. In this case, if any failure or problem is detected, the products can be withdrawn in a timely manner.
We cannot fail to mention the food industry, where the handling, transformation, packaging and distribution protocols are just as rigorous as in other industries. Here, not only hygiene is important, but also the conservation of the products to avoid the proliferation of bacteria and, in any case, the contamination of batches. In the food industry, concern for guaranteeing public health prevails.
In all these cases, Good Manufacturing Practices (GMP) – also known as Good Manufacturing Practices (GMP) – and Good Hygiene Practices are followed. Likewise, they are regulated by state bodies, such as the Spanish Agency for Medicines and Health Products (AMPS), and community bodies, as is the case of the European Union and its Good Manufacturing Standards (GMP).
These are the aspects that explain the importance of this regulation:
GMP standards focus on seven fundamental aspects that guide both the production and distribution of products. The main components of these standards are described below.
In GMP regulations, qualified personnel is essential. That is, employees participating in the manufacturing process must have not only training related to the industry, but also receive continuous training to understand, apply and evaluate their own work against the application of the corresponding regulations. In addition, there must be a clear structure in the production chain, where all operators and managers at each moment of the process are recognized.
Facilities must be adapted or built specifically for the industry to which they belong. This is essential to comply with high standards of hygiene, design, air conditioning, delimitation of work areas, among others, to avoid any type of contamination. In addition to this, the equipment installed in these spaces must be suitable for the production process and receive periodic maintenance. This is not only important for the efficiency of operations, but also to reduce errors or failures in the final products.
These three moments – production, storage and distribution – must be documented. Why is this aspect important in GMP regulations? This is because, according to current regulations, products must be correctly labeled and have an assigned batch. As part of traceability, this information allows us to know the conditions in which the products were manufactured, handled and stored, which can give clues to errors, contamination or degradation.
Following the above, documentation is essential in the procedures that follow GMP standards. All processes – including distribution – must be recorded in detail and accurately. Thus, if a health alert were received, manufacturers or distributors could act quickly to remove specific batches from the market, in addition to stopping production to avoid additional problems.
Quality controls are essential to guarantee that products meet the specifications established according to the industry and the corresponding regulations. What are the aspects that are verified? Physical, chemical and microbiological tests are carried out at different stages of the manufacturing process, in addition to randomly taking final products to corroborate their suitability. Production, packaging, laboratory and other specialist personnel – such as industrial engineers and chemical engineers – are responsible for recording results and validating continued operations.
GMP regulations require regular internal and external inspections and audits. This is important to identify possible non-compliance with standards, failures in safety and hygiene protocols, as well as poor control of equipment (ie calibration, maintenance, replacement). The detection of areas for improvement allows the application of GMP regulations and, by extension, the care of consumers.