ABSTRACT
Providing data for regulatory submissions and product release documentation is only part of the challenge facing the modern pharmaceutical analytical laboratory. External inspections of facilities and procedures means that a lot of infrastructure is required to support the actual analytical operation covering people, equipment, facilities, and data management. It is necessary to be able to demonstrate that staff performing current good manufacturing practices (cGMP) analyses has the correct qualifications and up-to-date training in all aspects of the role they are undertaking in the laboratory. Regulatory inspections may focus on the equipment life cycle management process in place in the manufacturing company, which should be applied to all cGMP equipment. The design specification would be prepared from the user requirements specification and functional requirements specification in cases where a bespoke instrument is being developed for a customer by an instrument manufacturer and is unlikely to be the case for GMP laboratories using inductively coupled plasma instruments.
