NEWS
October 9, 2026
Modular white room vs. Conventional construction: when to choose each
The GMP regulations in clean rooms are constantly evolving. The European Regulation has imposed a series of requirements and changes to be carried out by cosmetics, pharmaceutical companies and any other sector that has to use clean rooms or sterile areas. If you’re worried about getting the GMP certificate and complying with cleanroom regulations, here’s what you need to know:
The GMP regulations refer to The series of correct manufacturing standards that must be complied with by manufacturers of medicines, cosmetics and many other sectors. The main objective pursued by these requirements is for the product to have quality guarantees. Due to the significance of drug intake or the use of cosmetics for a person, Compliance with specific regulations is required.
these laws They are managed by the Spanish Agency for Medicines and Health Product (AEMPS) And they are basically a transposition of European regulations. The GMP (Good Manufacturing Practices) certification is an authorization that health agencies grant to companies to be able to manufacture medicines, cosmetics and medical devices..
Therefore, all the requirements that the AEMPS imposes through the GMP standards Its purpose is to improve the quality of the product and cover some minimum guarantees for the consumer. It is to ensure that all products that are in the norm and that circulate in the European market meet minimum standards.
The requirements that a clean room must meet in terms of GMP regulations will vary depending on the industry in question. For example, in the food industry, containment of particles and bacteria, in the Microelectronic industry An atmosphere free of particles that can affect the manufacture of VLSI circuits must be created.Very large scale integrated). Finally, in the pharmaceutical industry, , It is imperative that clean rooms ensure quality in manufacturing and control operations.
To obtain the GMP certificate, the clean rooms must:
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So, for Compliance with GMP regulations is essential that both the design as the clean room construction It is carried out by professionals in this field to manufacture products regulated according to regulations.
It must include the processes and operations that the industry in question will carry out. The best suited flow chart will be estimated Taking into account the functionality of the room, maintenance and control. Then the plans and documents may be later approved by the relevant authorities.
When the project has been designed and approved, it will be necessary to move on to the architecture of the same. Similarly, this point must take into account the Issues related to floor covering, ceilings and enclosures and technical requirements existing taking into account the GMP standards of the AEMPS.
You have to take into account the classification of the different types of rooms that the company requires since Each of these will need a different filtering system. As a general rule, it must be taken into account that the filters are of high efficiency, which requires the installation of prefiltration stages and intermediate filtrations. Once these systems are installed, it will have to be verified that they are effective before validating them.
In the white rooms, Temperature and humidity is a key factor. Therefore, the treatment of the air must be adjusted to the conditions and measures determined for each type of industry according to the GMP regulations. This air must create a sweep that purifies the place, so central air conditioning systems are commonly used since allow more control and offer low consumption.
In accordance with the provisions of the regulation of the clean rooms, these places must have An exhaustive control over the cleanliness of personnel and material that enters them. The full guarantee of this cleaning is usually achieved by equipment that are included in said rooms. Some examples are air showers or gas extraction booths.
To obtain the GMP certificate It is necessary to submit a request to the AEMPS. This application must be accompanied by a technical report or pre-qualification file, which reflects the Compliance with GMP regulations. The presentation of this usually takes half a month and consists of two audit stages:
The cost of certification 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. This audit process depends on each country, since they can be required every year or every two and their non-compliance can lead to the suspension of operations manufacturer’s commercial and/or cancellation of registration.
In conclusion, it is worth noting The importance of complying with GMP Whiteroom Standards. This compliance is paramount to ensure the quality of the products and processes of the industries. Therefore, putting yourself in the hands of experienced professionals is the safest and most feasible option and remember that, If you don’t know how to get your GMP certificate or you have doubts about what obligations you have according to your sector, you can Get in touch with us and we will answer all your questions.
Cross contamination occurs when a product or material that is made up of a potentially polluting or harmful substance comes into contact with another product that cannot receive that substance. When both products come into contact, contamination has occurred, since a substance that does not have to damage one product can make another not suitable for sale.
In addition to the correct manufacturing regulations, there is the ISO regulation, which the clean rooms must also follow to ensure that everything is correct, meets the relevant standards and can be used safely.
Yes, for any company that needs to comply with certain GMPs to be able to produce its products, that its cleanroom does not comply with the regulations can lead to the authorities not allowing the production and sale of the company’s products, so it is essential to comply with the established guidelines.
The objective of the GMP standards for cleanrooms is to ensure that there are correct practices in their design and use that ensures that safety and quality standards are met..
The GMP regulations and the ISO regulations refer to clean rooms as the places where the manufacturing processes of cosmetics, medical devices, medicines, food, etc. take place. both in the way they reach the final consumer and in their preparation for hospitals and clinical trials.
In addition to the requirements related to the design of the clean room, the staff is also important when it comes to complying with the GMP regulations, specifically with regard to guaranteeing the cleanliness of both yours and the equipment you use during your time inside the room.
A GMP audit consists of an audit carried out by a third party with the aim of knowing if your company is complying with the safety guidelines and good practices detailed in the GMP regulations.
We handle the design, installation, management, and maintenance of cleanrooms, prioritizing safety and offering customized solutions. We will also contact you to discuss your project and prepare a quote tailored to your needs.
