How are technology, engineering and GMP requirements connected? Engineering departments and pharmaceutical operators work closely together to ensure the implementation of Good Manufacturing Practice in operational practice. Therefore, engineering departments and suppliers of equipment and systems must have basic knowledge of typical GMP requirements. It is important to clarify the following questions: What are incontrovertible requirements from the GMP regulations for pharmaceutical technology and what scope is available for interpretation and implementation?
Only qualified rooms and supply systems such as air conditioning and ventilation systems and water pipes may be used for the production of medicinal products and active ingredients. Environmental conditions such as temperature, humidity and particle count must be monitored and controlled and records must be easily accessible. Changes to buildings or rooms that could have an impact on process flows or conditions must be subject to a change control procedure.
