Design & engineering in the pharma & biotech field
design of factories, manufacturing facilities, laboratories, manufacturing processes in the fields of pharma and biotech, and project management of this type, requires a combination of theoretical knowledge, practical experience and a thorough understanding of the unique principles that characterize these industries.
Understanding customer needs, regulatory and legislative requirements, reflected in, inter alia, the Ministry of Health, FDA and GMP guidelines, is essential to establish a technology facility that will produce a safe and high-quality product that complies with international regulatory standards. At the beginning of each planning project, the relevant design and information products will be forwarded to the client’s co-sponsors and then to the Ministry of Health to get a “green light” to progress.
To this end, it is of great importance to document and transmit the relevant information and data to each of the various authorities as required. Accurate and orderly documentation, adhering to all the rules, using appropriate models for managing complex engineering projects, assimilating quality methodologies, proper engineering conditions and production among contractors, managers and project employees, and selecting the most appropriate technologies for customer needs are essential steps for obtaining product quality and facility facilities. Compliant with the latest regulatory standards. At the end of the project, the facility must undergo an authority phase which will include, among other things, validation of the structure and infrastructure systems such as water systems, clean rooms, computer systems, software, control, infrastructure and production equipment.
Success in audits that will be conducted at the facility by the health authorities after accreditation is imperative to obtain approval for factory production and marketing authorization.