GMP guidelines for quality assurance
Quality assurance guidelines for cleanrooms are crucial as they ensure a controlled environment with minimal airborne particles. In the pharmaceutical industry and drug production, even the smallest impurities can affect product quality and cause significant hazards. The GMP guidelines are the decisive standard for working in a cleanroom. Cleanroom .
What is the meaning of GMP?
GMP stands for Good Manufacturing Practice.
GMP refers to quality assurance guidelines that ensure consistent quality standards in the production and testing of medicinal products or active ingredients. However, the production of cosmetics or foodstuffs can also have an impact on human health, which is the main focus here. GMP is therefore about ensuring the quality, safety and efficacy of products during production and minimizing risks for consumers.
What GMP guidelines are there?
When producing sensitive products within the EU, the GMP guidelines of the so-called EU GMP guidelines must be taken into account. In order to work in compliance with GMP, manufacturers must introduce a quality management system that covers the following aspects of production, among others:
- Qualification of personnel, systems and equipment
- Validation of processes and methods
- Documentation of all steps and measures
- Control of raw materials and end products
- Batch traceability
- Compliance with hygiene and cleanroom regulations
All steps must be documented and validated to ensure complete traceability.
Are the GMP guidelines mandatory?
Compliance with the GMP guidelines is mandatory for manufacturers who wish to approve a medicine and place it on the market. The GMP guidelines of the country in which production takes place must be applied. For a company with pharmaceutical production in Germany, for example, the EU GMP guidelines are decisive. The GMP requirements defined therein are made mandatory by the German Medicinal Products Act (AMG) and the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV).
Compliance with the GMP guidelines is monitored by the state pharmaceutical authorities (GMP/GDP inspectorates). In Germany, for example, the federal states are responsible for monitoring GMP guidelines. As a rule, the regional council or the district government is responsible for this. After a successful audit in accordance with the GMP guidelines, the company receives a GMP certificate. This officially confirms that the audited manufacturing process complies with the specified “Good Manufacturing Practice” standards for quality and safety.
Does GMP production have to take place in clean rooms?
Annex 1 of the EU GMP guidelines provides clear specifications for the manufacture of sterile products, which must take place in clean areas into which personnel and/or equipment and materials can only enter via airlocks. The requirements for cleanrooms include cleanroom classification, air quality, sterilization and minimum intervals for repeated qualifications.
The GMP guidelines distinguish between four classes for the cleanroom production of sterile medicinal products:
- Class A: The local zone for high-risk work processes, e.g. filling area, open ampoules and vials, production of aseptic compounds.
- Class B: for aseptic preparation and filling; as an environment for a Class A zone.
- Classes C and D: Pure areas for the less critical steps
The cleanroom classes are classified in accordance with the EN ISO 14644-1 standard, which specifies the permitted number of particles per cubic meter of air volume.
For the classification, the air is measured at various measuring points in the Cleanroom to verify particle purity. Particularly in the especially critical GMP A and B areas, permanent monitoring of the particle load is carried out and recorded during operation.
ATTENTION: Revision of EU GMP guidelines, Annex 1 becomes binding on August 25th
The EU GMP guideline, Annex 1 “Manufacture of sterile medicinal products” was revised in 2022. After a one-year transition phase, it will enter into force on August 25, 2023. The revised version has become more comprehensive and contains, for example, higher qualification requirements with more extensive documentation and verification obligations as well as a comprehensive contamination control strategy. If you have specific questions on individual points, please do not hesitate to contact us.
