Published: November 2016
Table of Contents ( 645 KB)
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Dave DiProspero, Co-Team Leader of the ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition), offers insight about what brought on the update and what core takeaways you’ll get from the new edition of this Guide.
This is the third edition of the ISPE Baseline® Guide for New and Renovated Oral Solid Dosage (OSD) facilities. It focuses on compliance with the current regulatory expectations.
Technical content within this Baseline Guide covers pharmaceutical facilities for the manufacture of OSD forms, including tablets, capsules, and general powders. It may also be applied to pilot and clinical supply facilities and is intended to supplement Good Engineering Practice (GEP) with suggested approaches to Good Manufacturing Practice (GMP).
The ISPE Baseline Guide: OSD Forms is intended to be used by various industry professionals for the planning, design, engineering, construction, commissioning, qualification and operation of both new and renovated pharmaceutical OSD facilities. It is intended to be used to develop technically sound and compliant solutions while offering flexibility to meet specific facility and project needs.
The ISPE Baseline Guide: OSD Forms is intended to offer a tool for consistent framework for regulatory interpretation, while still allowing a flexible, innovative, and compliant approach to facility design, construction, commissioning, and qualification. This approach is intended to allow manufacturers to better serve their customers by helping reduce costs and improve product quality. Additionally, this Baseline Guide will provide an overview of potential new technologies, which are being applied selectively in the industry.
Some of the major enhancements and revisions to the third edition include:
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