The guidelines consist of five integral concepts: Product and Process Understanding:Ī firm grasp of the product and process is vital to determining system requirements and for making science- and risk-based decisions to ensure the system is “fit for use.” This concept focuses on aspects that are crucial to patient safety, product quality, and data integrity.”(2) Life Cycle Approach Within a QMS: However, the guidelines’ best practices can serve as a compliance framework for regulated industries while underscoring the importance of validation to reduce risk.(3) Computer system validation (CSV) based on adherence to GAMP guidelines requires companies and suppliers to embrace collaboration so that respective risk management responsibilities are fully understood. A GxP rather than a prescriptive approach, GAMP 5 doesn’t mandate software validation. The difference between 21 CFR Part 11 and GAMP 5 is that the latter is not a regulation. The intent of GAMP 5 principles is “to provide a cost-effective framework for good practice to ensure that computerized systems are fit for use and compliant with regulation.”(2) The procedures offer the latest thinking and best practices for computer systems validation. In 2008, the International Society for Pharmaceutical Engineering (ISPE) released “GAMP 5: A Risk-Based Approach to Compliant GxP Systems,” an update to its 1991 guidelines for general and life sciences manufacturers.

In 2002, the FDA issued “General Principles of Software Validation Final Guidance for Industry and FDA Staff,” requiring risk-based software validation.

In 1997, the FDA issued 21 CFR Part 11 guidance for pharmaceutical companies to ensure proper validation of electronic records and signatures (updated in 2003 to reinforce the need for computer-based validation).In 1992, the European Union (EU) put out Annex 11 (updated in 2011) to reduce risk for medicinal product quality manufacture involving computerized processes.Food and Drug Administration (FDA).(1) The findings resulted in a cascade of regulatory requirements and guidelines for more rigorous computer and software validation: An analysis of more than 3,000 medical device recalls between 1992–1998 revelated that in 79% of those cases, software defects were to blame, according to the U.S. In the 1990s, computer validation issues became a sizeable stumbling block for life sciences companies. This article will review GAMP and why its benefits for computer validation still resonate. Good Automated Manufacturing Practice (GAMP) guidelines are a key resource to help manufacturing minimize that risk. Faced with new competitors, more complex data-centric products, and greater regulatory demands, manufacturers are turning to automation as a way to achieve differentiation and avoid potential pitfalls like failed audits or recalls.

While life sciences industry growth in 2020 and beyond appears promising, risk avoidance remains a concern for most companies.

Gamp categorization