Regulatory Issues - Lyophilization
A Guide To Good Manufacturing Practices 2nd EditionA Guide To Good Manufacturing Practices 2nd Edition
Product Type: Market Report
Published Date: November 2004
Published By: Drug & Market Development
Page Count: 386
Order Code: R294-0117
P
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A Guide to Good Validation Practices (Second Edition)A Guide to Good Validation Practices (Second Edition)
Product Type: Market Report
Published Date: December 2004
Published By: Drug & Market Development
Page Count: 133
Order Code: R294-0124
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Apptec Laboratory Services, Inc. Warning LetterPublic Health Service
Food and Drug Administration
Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
J
http://www.fda.gov/foi/warning_letters/g4808d.htm
Freeze-Dryers Particle Monitoring Requirements, 2003Freeze-Dryers Particle Monitoring Requirements, 2003
19-Dec-03
Mark Hallworth
Pharmaceutical Business Manager
Introduction
Freeze-drying is used to produce the majority of today's dried pharmac
http://www.pmeasuring.com/particleCounting/appNote...
Good Manufacturing Practices (3rd Edition)
Good Manufacturing Practices (3rd Edition)
Published Date: July 2006
Published By: Drug and Market Development Publishing
Page Count: 423
Order Code: R294-212
$795 Online Download
Chapter
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Guidance for IndustryChemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA
DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes only.
This guidance documen
http://google.fda.gov/search...
GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERSGUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS
Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer an
http://www.fda.gov/ora/inspect_ref/igs/subst.html
LYOPHILIZATION OF PARENTERALSDEPT. OF HEALTH, EDUCATION, AND
WELFARE PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
*ORA/ORO/DEIO/IB*
Date: 4/18/86 Number: 43
Related Program Areas:
Drugs, Biologics, Diagnostics
ITG
http://www.fda.gov/ora/inspect_ref/itg/itg43.html
Process Analytical Technology
Process Analytical Technology
Introduction
The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be teste
http://www.fda.gov/Cder/OPS/PAT.htm
Process Validation: Successes and Failures on InspectionProcess Validation: Successes and Failures on Inspection
WCBP 2005 January 10, 2005 WCBP 2005 January 10, 2005
Mary Malarkey, Mary Malarkey, Director, Director,
Office of Compliance and Biologics
http://www.fda.gov/cber/summaries/wcbp011005mm.pdf
The rules governing medicinal products in the European UnionThe rules governing medicinal products in the European Union
Volume 5
Pharmaceutical legislation
THE RULES GOVERNING MEDICINAL PRODUCTS IN
THE EUROPEAN UNION
Volume 1 Pharmaceutical legislation
http://pharmacos.eudra.org/F2/eudralex/download/vo...