SPE Baseline Guide: Oral Solid Dosage Forms (Third Edition)

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.