Research Catalog

Guidance for industry : process validation, general principles and practices.

Title
Guidance for industry : process validation, general principles and practices.
Publication
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER) : Center for Veterinary Medicine (CGMP), [2008]

Available Online

https://purl.fdlp.gov/GPO/LPS110592

Details

Additional Authors
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Biologics Evaluation and Research (U.S.)
  • Center for Veterinary Medicine (U.S.)
Description
20 unnumbered pages : digital, PDF file
Alternative Title
Process validation, general principles and practices
Subject
  • Biologicals > Evaluation
  • Drugs > Testing
  • Manufacturing processes > Evaluation
Note
  • Title from PDF title page (viewed on Mar. 24, 2009).
  • "Draft guidance."
  • "November 2008."
Bibliography (note)
  • Includes bibliographical references (page [20]).
System Details (note)
  • Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf ; current access is available via PURL.
Call Number
GPO Internet HE 20.4802:P 49/6
OCLC
marcive316871659
Title
Guidance for industry : process validation, general principles and practices.
Publisher
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER) : Center for Veterinary Medicine (CGMP), [2008]
Type of Content
text
Type of Medium
computer
Type of Carrier
online resource
System Details
Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf ; current access is available via PURL.
Bibliography
Includes bibliographical references (page [20]).
Connect to:
https://purl.fdlp.gov/GPO/LPS110592
Added Author
Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Center for Veterinary Medicine (U.S.)
Gpo Item No.
0499-T-02 (online)
Sudoc No.
HE 20.4802:P 49/6
View in Legacy Catalog