FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability July 1995

GUIDANCE DOCUMENT

• Docket Number: 95D–0164
• Issued by: Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a guidance document concerning the use of pilot facilities for the development and manufacture of biological products.
The guidance document, entitled ``Center for Biologics Evaluation and Research; Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Guidance,'' provides guidance by the Center for Biologics Evaluation and Research (CBER) to manufacturers of biological products to clarify the licensing requirements for the use of small scale and pilot facilities for the
development and manufacture of biological products. These facilities are sometimes collectively referred to by industry as pilot facilities.This guidance document is intended to provide increased flexibility for industry without diminishing public health protection.
 

---

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 95D–0164.

Questions?