GAMP-5: What is it?
GAMP, founded in 1991, stands for Good Automated Manufacturing Practices and is a trademark of the International Society for Pharmaceutical Engineering (ISPE). GAMP-5 is the most current iteration and was launched in 2008. It lays out a set of principles and procedures that help ensure that automation equipment has the required quality. One of the core principles of GAMP is "quality by design"; that quality must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production from the raw materials, facility and equipment to the training and hygiene of staff.
So what does this mean for automation equipment? It means that clients in the medical device, pharmaceutical and life sciences industries are assured that their machines are designed and built under a Total Quality Management System. It is a formal process of rigorous documentation, testing, and methodical process steps that validate clients' required project specifications. It begins with a client's User Requirements Specification for the machine, from which a Functional Requirement and a Design Specification is created. Those documents are the basis for the traceability matrix for the formal testing milestones of Internal Acceptance, Factory Acceptance, and Site Acceptance. DWFritz Automation's processes are GAMP-5 compliant, allowing us to provide the quality of service you require for your business.