ISPE, a global not-for-profit association of pharmaceutical manufacturing professionals, announced the availability of its newest technical publication, the Good Automated Manufacturing Practice (GAMP) Guide: Validation of Laboratory Computerized Systems. ISPE provides a wide range of Member-driven educational programmes and resources to pharmaceutical industry practitioners worldwide, and is the originator and owner of all GAMP programmes. The new publication joins ISPE's extensive library of technical guides, developed in cooperation with global regulatory agencies and industry professionals.
The GAMP Good Practice Guide: Validation of Laboratory Computerized Systems is targeted to laboratory, quality, and computer validation professionals responsible for defining and managing laboratory validation practices in regulated life science industries. Information technology personnel supporting these systems, end users, software developers, and suppliers of laboratory computerized systems will also benefit.
With a focus on computerized laboratory instrumentation, data management, and analysis systems, this Guide serves as a supplement to the broader GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture - GAMP 4. The new Guide describes laboratory computer systems subject to good manufacturing practice (GMP), good laboratory practice (GLP), or good clinical practice (GCP), and the key elements involved in a system's life cycle from initiation to retirement. The publication offers guidance for addressing strategic and tactical computer system validation issues such as: examination of the traditional system development life cycle and its applicability for most laboratory computerized systems; identification of characteristics that distinguish various laboratory computerized systems; development of a rationale for scaling the effort associated with the validation of laboratory computerized systems; development of a strategy for supplier assessment to supplement company specific validation activities; further definition of the GAMP 4 risk assessment approach to make it more applicable to laboratory computerized systems; definition of necessary controls to maintain laboratory computerized systems in a validated state; recommendation on activities to be performed when a laboratory computerized system is no longer suitable for its intended use.
For more information about the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems and to purchase the publication on-line, visit www.ispe.org/publications.
GAMP is a program of the GAMP Forum, a technical sub-committee of ISPE whose mission is to promote understanding of the regulation and use of automated systems within healthcare industries. The GAMP Forum's strategy for computer systems compliance is described in GAMP 4, which provides a basic framework for validation and addresses considerations unique to particular classes of systems.
Since the publication of GAMP 4 in late 2001, several GAMP Special Interest Groups (SIGs) have developed Good Practice Guides addressing these special considerations and systems classes. In addition to the GAMP Good Practice Guide: Validation of Laboratory Computer Systems, these Guides include: GAMP Good Practice Guide: Calibration Management; GAMP Good Practice Guide: Validation Process Control Systems (VPCS); GAMP Good Practice Guide: Legacy Systems (Published in Pharmaceutical Engineering, Vol. 23, No. 6); GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for nearly 23,000 pharmaceutical manufacturing professionals in 80 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida.