By Steve Tallant, Director, Product Management and Marketing
What is GAMP?
GAMP, also known as 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.
Why follow these guidelines?
First and foremost, because most markets in the world require it. Second, because it makes sense to ensure patient safety.
How did GAMP become THE guideline for manufacturers?
GAMP started in the UK in 1991 primarily as a response to the US FDA’s inspections increasingly focusing on the myriad computerized systems responsible for more and more of the pharmaceutical manufacturing process. GAMP became a global initiative as part of the International Society for Pharmaceutical Engineering. The first formal guide was published in 1995, with new revisions coming in 1996 and 1998. These versions strictly focused on good manufacturing practice systems.
With the release of GAMP 4 in 2001, the guidelines expanded to all associated systems in the pharmaceutical manufacturing process. GAMP 5 was introduced in 2008, and has been a well-received standard bearer for the pharmaceutical industry. It adapted to the increased worldwide regulatory environment, and helps ensure that manufacturers are compliant to applicable regulations. Its broad library of Good Practice Guides (GPGs) cover the full life-cycle of computer systems involved at every stage of the pharmaceutical development and manufacturing process.
Pharmaceutical manufacturing history mirrors most other physical goods manufacturing history. Manual processes led to machine-aided manual processes. This led to partially and now, almost fully computer software driven automated processes. Manual and semi-manual processes have a physical checklist of steps that are auditable.
Automated processes are driven by computer software. When these systems were introduced, there were no standard checklists or auditable processes to govern the software elements. There needed to be a standard way to consistently govern and audit the software systems running the automated pharmaceutical manufacturing processes. Learn more about how to jump-start your GAMP 5 documentation.
The integrity and accuracy of records and data are essential throughout the product life cycle, from research and development to pre-clinical studies, clinical trials, production and quality control to marketing; this is also reflected in the objectives and activities of GAMP. In summary, the GAMP CoP’s (Communities of Practice) mission, as defined by the GAMP Global Steering Committee is:
“Collaborating with regulators and industry experts, GAMP promotes the innovative use of automation and computer technology by applying a science- and risk-based approach that safeguards patient safety, product quality, and data integrity throughout the product life-cycle.”