A question that gets frequently asked is what GMP-compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products / APIs.
The short answer is: the system must be qualifiable.
Since this require some clarification, here is a more elaborate answer. To be clear from the very start, there is no regulatory document or general GMP certification for equipment. This is simply impossible as pharmaceutical manufacturing processes are quite different – dry granulation, tableting, fermentation, sterile filling and others are a good example and if you add manufacturing processes to the classic (chemical) API production, this results in even more.
The product itself can pose various requirements for the production equipment. It makes a big difference for the design of a system whether the manufactured product must be sterile or whether the product is temperature or oxygen sensitive. This impacts the system design. Even though these requirements are quite diverse, there are some general specifications that apply to every GMP compliant equipment design in the GMP regulations.
- The system may not influence the product quality in a negative way
- The system must be easy to clean
- The system must to comply with applicable technical rules
- The system must be suitable for its purpose
More information surrounding this topic can be found here.
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