GMP requirements demand a great deal of effort from all employees. Highcare supplies GMP EMA-compliant workspaces constructed from specially selected sterile materials that are safe to use in a GMP cleanroom and easy to clean. Experience shows that incorrect choices, such as unsuitable materials or construction details, can be a daily annoyance during cleaning work. The hollow wall system containing all the pipes makes cleaning considerably easier and the wall can be easily opened in the event of an emergency.
Highcare’s unique air technology purifies spaces by flushing them 3-dimensionally. This state-of-the-art air inlet technology is a first step towards a clean environment where the entire process is compliant with GMP (Good Manufacturing Practice) standards.
Certification
The consistent quality of a product or medicine can never be fully determined by analyzing the composition alone. Not every pill can be checked individually. Quality can therefore only be guaranteed if the entire production process is carried out in a strictly predefined and controlled manner using a EU GMP cleanroom classification. A GMP EMA-certified production method is therefore a requirement when producing medicines. Highcare supplies turnkey GMP clean rooms with four classifications related to EMA GMP: A, B, C and D.
GMP requirements for cleanrooms
GMP cleanroom classification requirements are the standard quality assurance in human, veterinary, pharmaceutical and cosmetic industries. Precise records are kept of how a product is made under consistently identical conditions. Working in cleanrooms is an essential part of this process.
Procedures and protocols
During both the construction process (IQ phase) and the use of the cleanrooms (OQ phase), all activities, raw materials, intermediate products and finished products are monitored, recorded and coordinated according to predefined protocols. For example, the cleaning procedure is carried out exactly according to protocol and at fixed times. Should something subsequently turn out to be wrong with a particular batch of medicines during production, it is always possible to trace how the product was made, who tested it and which raw materials were used. It goes without saying that the manageability of the production environment plays a major role in the development processes of pharmaceutical, cosmetic and food products. Highcare starts the design, the DQ phase, with you. The clean room GMP classification requirements are factored in from that moment onward. The draft design is developed into a construction plan, in close consultation with you. Every step in the process is recorded and documented from the initial design through to evaluation.
International
The cGMP guidelines apply, among other things, to the manufacturing of finished pharmaceutical products, including large-scale production of pharmaceutical products or, in hospitals, the preparation of pharmaceutical products for clinical trials. The guidelines are part of the World Health Organization’s certification scheme for the quality of internationally traded pharmaceutical products. Many countries refer to the GMP principles in their national legislation. To achieve GMP certification for your pharmaceutical, cosmetic or food products, production and handling processes naturally rely on a cleanroom environment. Only then will the circumstances be completely controllable, thanks to the GMP requirements. We work with you through the DQ and IQ phases, right up to the moment of validation.