What’s new in the GAMP 5 second edition?

Good Automated Manufacturing Practices (GAMP) is a technical sub-committee of the International Society of Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automation systems in the pharmaceutical industry. 

One of the core principles of GAMP is that “The quality can’t rely on the test of each batch, but it requires to be designed in the manufacturing process from the beginning”! 

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. 

The Beginning of GAMP  

GAMP was established in Britain in 1991, aiming at responding to the expectation of the United States Food and Drug Administration for the continuous development of GMP compliance of production and related systems. GAMP issued its first guidance in 1994. Soon after, the organization established a partnership with ISPE and officially became a part of ISPE in 2000. GAMP has been supported by many regulators in the United States, Europe and Japan for many years, and now it has become a globally recognized good practice. 

Risk-Based Tools in the GAMP 5 Second Edition  

The GAMP 5 second edition was released in July 2022. The risk-based method in the second edition complies with and maintains the principles and framework of the first edition, and updates its application in the modern world, including the increasing importance of service providers, the development of software development methods and the expanded use of software tools and automation testing.

A Shift to Agile Digital Tools  

Agile software development, software tools, distributed ledger system (Blockchain), artificial intelligence (AI) and machine learning (ML), IT infrastructure and critical thinking are the topics new within the second edition of GAMP. Cost-effectiveness is mentioned several times within the document. 

The traditional V-Model is widely used in the pharmaceutical industry; however, the new agile approach introduced in the second edition of GAMP may not expect a fully formed user requirement specification (URS) early in the development lifecycle when developing a GxP-regulated system. 

Meanwhile, during the system implementation process, testing with automated tools is more widely used. GAMP clarifies the tools used for system lifecycle, IT and IT infrastructure processes are GAMP software Category 1, in which validation is not required. 

Innovative Technologies Elevate GAMP  

ISPE has another guidance regarding IT infrastructure compliance and control, the key concept for infrastructure qualification is a “one qualification, many implementations” model. A robust IT management system is also required as a supplement to the existing quality management system. 

Critical thinking is also emphasized. Experienced subject matter experts (SMEs) should apply critical thinking to determine test cases and direction based on a documented risk assessment, generate supporting evidence only where it brings value to the quality of the testing, spend more time actively testing to find defects and less time generating specifications in advance. 

Blockchain, AI and ML are the recent new technologies that are accelerating the industry into the future.