Institute of Good Manufacturing Practices India
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EQUIPMENT DESIGN AS PER GMP COMPLIANCE

GMP-compliant equipment design is gaining lot of expert’s interest as it will be more suitable for the manufacturing of medicinal products/APIs. Consequently, the only feature an equipment design should have is: system has to be qualifiable.

Presently, there are no official guidelines or regulatory document which specifies GMP certification for equipment. As pharmaceutical manufacturing processes are complex procedures: granulation, tableting, fermentation, sterile filling and others, for example. Sometimes, the requirements for product manufacturing require different environments, temperature controls and oxygen. All of these requisite demands of manufacturing pose difficulty in designing system as well as procedures. This certainly impacts system design.

However, these requirements are quite diverse; there are some general specifications that apply to every GMP compliant equipment design in the GMP regulations. Following are the requirements for GMP- compliant system design


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