One of the core principles of GAMP is that quality cannot be tested into a batch of product but 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.
Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing.
GAMP has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognised good practice worldwide.