You are being redirected because this document is part of your ASTM Compass® subscription.
    This document is part of your ASTM Compass® subscription.

    If you are an ASTM Compass Subscriber and this document is part of your subscription, you can access it for free at ASTM Compass

    FDA Enforcement in Bioprocessing Facilities

    Published: 01 January 1990

      Format Pages Price  
    PDF (100K) 6 $25   ADD TO CART
    Complete Source PDF (2.3M) 155 $55   ADD TO CART

    Cite this document

    X Add email address send
      .RIS For RefWorks, EndNote, ProCite, Reference Manager, Zoteo, and many others.   .DOCX For Microsoft Word


    Biotechnology is a rapidly developing field. Concerns for the health and safety of workers, for the safety and efficacy of the biotechnically derived products, and for potential environmental contamination have been expressed. With the development of a consistent government-wide policy for the regulation of products derived from new biotechnologies, the United States government has taken steps at agency and interagency levels to dispel these concerns. Under the authority of the Food, Drug, and Cosmetic Act of 1938, the U.S. Food and Drug Administration (FDA) evaluates and regulates the safety of biotechnology-derived products in the same way that it does for conventionally manufactured products. Scientific, safety, and regulatory issues are considered prior to approval for commercial production. Once a product receives approval, enforcement of the laws and regulations at the manufacturing level is accomplished by FDA's field personnel. The individual firm's manufacturing and quality control procedures are reviewed and evaluated to determine if they are in compliance with the Current Good Manufacturing Practice regulations. The FDA believes the current laws provide adequate regulatory protection and are sufficiently comprehensive to regulate products regardless of whether they are manufactured by traditional processes or are the products of biotechnology.


    bioprocessing, biotechnology, enforcement, genetic engineering, inspection, safety, recombinant DNA, regulations

    Author Information:

    Smith, B-H
    Director of investigations, U.S. Food and Drug Administration, Chicago, IL

    Committee/Subcommittee: E48.01

    DOI: 10.1520/STP26079S