Good Automated Manufacturing Practice

Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.^[1] 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.

History

GAMP's origins can be traced to the United Kingdom in 1988, when software developers David Forrest and Colin Jones, through their company FJ Systems, developed real-time control and production information management control systems for pharmaceutical manufacturers. They worked with ICI Pharmaceuticals' Tony Margetts on the problem of validating systems that were increasingly becoming more software-based than mechanical- and electrical-based. This culminated in a five-page document called VMAN I, mapping the older installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases of equipment validation to a more modern software validation lifecycle. A second version was created upon additional feedback.^[2]

GAMP itself was eventually founded in 1991 (with the previously mentioned Margetts as chairman of the editorial board) to deal with the evolving U.S. Food and Drug Administration expectations for Good Manufacturing Practice (GMP) compliance of manufacturing and related systems.^[3] GAMP published its first draft guidance in February 1994, with version 1.0 of it arriving in March 1995. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. GAMP 4 was released a year later, followed by GAMP 5 in 2008.^[4] GAMP has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognized good practice worldwide.^[5]

Publications

GAMP 5

ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP 5) was released in February 2008.^[6]

The documentation surrounding GAMP 5 is described by the ISPE and researcher Jim John as follows^[7]:

GAMP 5 guiding principles and framework;
appendices on general, management, developmental, operational, and special interest features of the guidance;
good practice guides on aspects such as laboratories, testing, process control, and electronic records management among others; and
additional templates, training materials, and articles on GAMP.

The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind^[7]:

1. Make product and process understanding clear. 2. Approach the life cycle from the standpoint of a quality management system. 3. Make life cycle activities scalable. 4. Ensure quality risk management is science-based. 5. Leverage supplier involvement into the system.

Other guides

As of February 2015, the ISPE has 13 guides, the latest published in October 2014, titled A Risk-Based Approach to Regulated Mobile Applications.^[8]