The pharmaceutical and medical device industries rely heavily on automated systems to maintain product quality, data integrity, and patient safety. To ensure the effectiveness and compliance of these systems, the International Society for Pharmaceutical Engineering (ISPE) introduced the Good Automated Manufacturing Practice 5 (GAMP 5) guidelines. With the release of the 2nd edition, GAMP 5 has undergone significant changes to align with evolving industry practices and regulatory requirements. This article explores the key changes in GAMP 5 2nd edition, highlighting how these modifications enhance automated systems validation and regulatory compliance.
Understanding GAMP 5 2nd Edition:
GAMP 5 2nd edition is a comprehensive guideline that provides a risk-based approach to the validation of automated systems in regulated industries. The framework aims to ensure that automated systems consistently perform as intended while meeting quality, safety, and regulatory requirements.
MEDVACON and our team of Quality and CSV Experts can assist in navigating the changes in GAMP 5 as well as incorporate the FDA critical thinking around CSA and CSV into your validation projects.
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