New book describes regulatory-compliant facilities for biopharmaceuticals

December 10, 2004—Research and Markets has announced the addition of A Guide to Good Facility Design Practice—The Design of Regulatory-Compliant Facilities for Biologicals and Biopharmaceuticals to their offering.

This guide examines the relevant regulations and gives simple, clear recommendations for compliance in facility design to the scientists and businessmen involved in their company’s future development.

In an environment where time is money, the last thing companies can afford is non-compliance. The development and production of drugs, including biopharmaceuticals and biologicals, is governed by national and international “good practice” regulations. The regulations include requirements for the design and construction of the facilities in which the activities are performed.

The Guide to Good Facility Design Practice enables scientific and managerial staff of biological and pharmaceutical companies to understand how to meet the requirements and constraints that are placed by the regulatory agencies upon the design of laboratory and factory layouts, their modes of construction and finishing and the key systems therein. In addition to learning how to meet these regulatory requirements in an economical manner, readers will be able to discuss their needs sensibly with architects and contractors. This Guide Covers:

• The FDA’s plans to increase GLP/GMP compliance in biological drug development and especially manufacturing
• The national and international “GXP” regulations required in R&D and manufacturing facilities handling biologicals and biopharmaceuticals.
• How to design research and manufacturing facilities that will provide proper levels of cleanliness, separation, containment and a logical flow of products and personnel
• How to determine the level of cleanliness and containment that would be required by a particular organism or manufacturing process.

This is an essential tool for any biological and biopharmaceutical development and manufacturing companies planning new facilities as well as new or expanding CROs and CMOs.