PharmaceuticalEngineeringGuides for Newand RenovatedFacilities

Volume 2

OralSolid Dosage

FormsFirst Edition / February 1998

3ORAL SOLID DOSAGE FORM FACILITIES

ISPE PHARMACEUTICAL ENGINEERING GUIDE

ORAL SOLID DOSAGE FORM FACILITIES

FOREWORD

For many years, the pharmaceutical industry has experienced increases in the cost of new facilities. Theseincreases in cost have been driven in part by uncertainty about the requirements for regulatory compliance.Some significant areas of concern are validation, particularly related to automation systems, and the trend tovalidate back to source utilities. The absence of a consistent and widely accepted interpretation of someregulatory requirements has led to one-upmanship. This practice of building increasingly technically ad-vanced facilities has led to increased cost, longer lead times and, in some cases, delays in bringing newproducts to market.

In May 1994, engineering representatives from the pharmaceutical industry engaged in a discussion with theInternational Society for Pharmaceutical Engineering (ISPE) and the Food and Drug Administration (FDA).As a result of that discussion in November 1994, ISPE began work on 10 facility engineering Guides, nowknown as the Baseline Pharmaceutical Engineering Guides. The first, Bulk Pharmaceutical Chemicals, waspublished in June 1996. The second, Oral Solid Dosage Forms, was published in February 1998. The thirdGuide, covering Sterile Manufacturing Facilities, was published in January 1999. Each Engineering Guidewas created by and is owned solely by ISPE. FDA provided comments on this and previous Guides, andmany of their suggestions have been incorporated.

As with the other Guides, the OSD Guide has been sponsored by ISPEs Pharmaceutical Advisory Council,made up of senior pharmaceutical engineering executives from owner companies, the FDA and ISPE seniormanagement. Overall planning, direction and technical guidance in the preparation of the OSD Guide wasprovided by a Steering Committee most of whom were involved in the BPC Guide. The OSD Guide itself wasproduced by a Task Team of around 50 individuals who expended a great deal of their own time in its prepa-ration and development.

Editors Disclaimer:This Guide is meant to assist pharmaceutical manufacturers in the design and construction of newand renovated facilities that are required to comply with the requirements of the Food and DrugAdministration (FDA). The International Society for Pharmaceutical Engineering (ISPE) cannot en-sure, and does not warrant, that a facility built in accordance with this Guide will be acceptable toFDA.

This document is owned by ISPE. No reproduction of the whole or any part of this document is to be madewithout written authority of ISPE.

INTRODUCTION