There are numerous pharmaceutical manufacturing processes, ranging from dry granulation and tableting to fermentation or sterile filling. Adding manufacturing processes from the classical (chemical) production of active pharmaceutical ingredients increases their number considerably. To some extent, however, pharmaceutical requirements are also observed when producing medical devices such as implants. The equipment used for these processes is as varied as the processes themselves. The product itself can place multiple requirements on the production equipment, too.
For the design of equipment, it makes a big difference whether the product to be produced needs to be sterile or not, or whether it is a highly effective product. In the latter case, not only do GMP design criteria have to be observed, but also requirements for personnel protection. A product or intermediate may, however, also be sensitive to oxygen or moisture. Obviously, all this affects the design of equipment. There might also be the rare case that the requirements of the authorities are not the same in different countries. The production method for WFI (water for injection) for example, was regulated differently in Europe than in the USA or in Japan until recently. In Europe, production of WFI was limited to distillation. This means that systems producing WFI by means of reverse osmosis would not have been GMP-compliant in Europe.
The purpose of this Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made. To this end, the guidance contains numerous references and points of contact, a sort of a road map, that offers detailed information on the requirements or ways of proceeding for individual cases.
The 115 page ECA Guide will be discussed in detail at the ECA Live Online Training: GMP-compliant Equipment Design on 22/23 November 2023. Each participant will receive a PDF copy of this Guide.
Please find the table of contents of the Guide below: