Pharmaceutical Guides: Current Pharma Practices For Facilities And Production SystemsSource: ISPE
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 prduct 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.
The ISPE Good Practice Guides may provide information or advice on a particular topic area, type of application or detailed technology. ISEP Good Practice guides give practical and technical details on how to apply principles and accept overall framework effectively in specific circumstances.