INotes on orangeSPE Guides are the “What”

The Baseline® Guides are a series of industry guides developed in partnership with the US Food and Drug Administration (FDA). Each volume in the series is a collaborative effort of industry leaders representing a broad cross-section of manufacturers and other industry experts.

The Guides document current industry practice for facilities and systems used for production of pharmaceutical products. They establish a baseline approach to process and facility design, construction, specification and verification, based upon clear understanding of the product and process requirements. The Baseline® Guide principles also may be applied to existing facilities as they are upgraded or modernized.

The GAMP Guide 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.

ISPE Good Practice Guides are the “How”

ISPE Good Practice Guides give practical and technical details on how to apply principles and accepted overall frameworks effectively in specific circumstances. These principles and frameworks may be defined in other ISPE documents (e.g., Baseline® Guides or main GAMP® Guide). The Good Practice Guides would then show how to apply these in practice in different cases.

The Good Practice Guides may provide information or advice on a particular topic area, type of application or detailed technology. They may suggest specific solutions in an area where several approaches or outcomes may be valid.

Reflecting current regulatory expectations and good practices, the GAMP® series of Good Practice Guides provide interpretation of regulatory standards to help improve compliance, quality and efficiency while reducing cost.

Product Quality Lifecycle Implementation® (PQLI®) Good Practice Guides provide information on global solutions to implementation challenges of ICH guidance.

View the complete 2014 Publications Catalog.