Created in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline Guides offer practical answers to the complex, dynamic challenges facing facility designers today by addressing GMP and non-GMP regulations.
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advance.
The ISPE GAMP® Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle.
Reflecting current regulatory expectations and good practices, the the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions.
Good Practice Guides (GPGs) provide information or advice on a particular topic area and explain underlying technical principles and suggest solutions in an area where no single answer is correct and where several outcomes may be possible.
ISPE's Clinical Trial Materials and Investigational Medicinal Products resources have been created to familiarize new investigational trial materials professionals with the terms and related information they need to be successful in their field. These are excellent tools to bring employees up to speed quickly and efficiently.
These Guidance Documents on Investigational Products are also available:
ISPE’s Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance.
Product Quality Lifecycle Implementation® (PQLI®) Good Practice Guides (GPGs) provide information on global solutions to implementation challenges of ICH guidances.
These handy pocket-size booklets are an ideal way to keep everyone informed of FDA regulations and guidelines.
ISPE periodically offers concept papers authored by groups (such as ISPE’s Communities of Practice (COP)) seeking to establish or clarify a concept, and to determine the level of interest in the concept discussed. The outcome may lead to a Guidance Document.
The GAMP® Cloud Special Interest Group (SIG) has now created three companion Concept Papers covering the topic of Software as a Service (SaaS) and Platform as a Service (PaaS).
ISPE periodically offers discussion papers authored by groups seeking feedback on ideas or initiating debate. The outcome may lead to a concept paper or Guidance Document.
Read the latest discussion papers on Process Validation and give us your feedback! Let the authors know about process validation approaches that have worked for you and your company and lessons learned from proposed approaches. Your industry examples and direction could be used to create an ISPE Good Practice Guide. Please send your feedback to email@example.com
Know Before You Go: 2017 Conference on Quality Culture & Quality Metrics
Monday, 24 Apr 2017 08.04
Just Published! Pharma Records and Data Integrity GAMP Guide
Thursday, 20 Apr 2017 10.04
Meet Jazz Pharmaceuticals – 2017 FOYA Project Execution Category Winner
Wednesday, 19 Apr 2017 11.04