Since the new Annex 1 came into force to the GMP’s, the requirements for equipment used in pharmaceutical productions is increased. Each pharmaceutical process requires the careful design of the needed equipment in order to provide the expected efficiency and performance, and in pharmaceutical manufacturing, a further step of complexity may be represented by the need to handle highly potent active pharmaceutical ingredients.
To facilitate the correct design of equipment compliant to GMPs, a new guidance document has been published by the ECA Foundation.
The first part of the document discusses general requirements that should always be part of the design of GMP-compliant equipment: the equipment must not adversely affect the product quality, it must be easy to clean, it must comply with applicable technical rules, and it must be fit for its intended use. User requirement specifications (URS) are the key document to demonstrate equipment is fit for the intended use, as stated by GMP Annex 15 (2015). The ECA guidance suggests translating the URS in a technical version to be submitted to the potential equipment supplier. The management of documentation along the design life cycle of a new piece of equipment is also taken into consideration.
The extensive use of data to monitor and document pharmaceutical manufacturing process represents another area of great attention. Requirements relevant to the design of validated computerised systems, data protection and data integrity must be kept in mind. ECA’s experts highlight the need to carefully delimitate areas subject to validation and their extention, particularly with reference to automated systems.
To learn more on this topic visit the EIPG website.