What is the Good Automated Manufacturing Practice (GAMP) Guide?
Good Automated Manufacturing Practice or (GAMP) and the ISPE Guide, describes a set of principles and procedures that ensure pharmaceutical products meet required quality standards. The core principles of GAMP state that quality cannot be tested at just one point for a batch of product. It must be built into each stage of the manufacturing process. The result is that, GAMP covers all aspects of production. This includes everything from the raw materials, to facility and equipment, to the training and hygiene of staff. Standard Operating Procedures (SOPs) are an essential component of all processes that affect the quality of the finished product. The GAMP guides also provide accepted methods for validating automated systems. It ensures that systems are developed using impeccable practice and meet agreed specifications. GAMP 4 has been in place for years and GAMP 5 is the currently active version of the guidelines. Systems that are produced according to the guidelines set forth in this G
