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Lyophilization and Protein Formulation
Regulatory Issues - Lyophilization

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GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS from the U.S. Food and Dru...
Votes:33 Comments:0
GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS from the U.S. Food and Drug Administration Office of Regulatory Affairs Note: This document is reference material for investigators and other FD READ MORE
http://www.fda.gov/ora/inspect_ref/igs/lyophi.html

Apptec Laboratory Services, Inc. Warning Letter
Votes:29 Comments:0
Public 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 READ MORE
http://www.fda.gov/foi/warning_letters/g4808d.htm

Guidance for Industry
Votes:23 Comments:0
Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA DRAFT GUIDANCE This draft guidance document is being distributed for comment purposes only.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 READ MORE
http://google.fda.gov/search...

GUIDELINE FOR THE DETERMINATION OF RESIDUAL MOISTURE IN DRIED BIOLOGICAL PRODUCT...
Votes:37 Comments:0
January 1990 Prepared by: Center for Biologics Evaluation and Research Division of Biochemistry and Biophysics Laboratory of Analytical Chemistry (HFB-740) Food and Drug Administration 8800 Rockvill READ MORE
http://google.fda.gov/search...

LYOPHILIZATION OF PARENTERALS
Votes:18 Comments:0
DEPT. 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 READ MORE
http://www.fda.gov/ora/inspect_ref/itg/itg43.html

A Guide to Good Validation Practices (Second Edition)
Votes:19 Comments:0
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 READ MORE
http://www.mindbranch.com/catalog/product.jsp...

A Guide To Good Manufacturing Practices 2nd Edition
Votes:32 Comments:0
A 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 READ MORE
http://www.mindbranch.com/catalog/product.jsp...

FTS Systems Introduces new AirJet? XE Precision Temperature CyCling System
Votes:35 Comments:0
FTS Systems Introduces new AirJet? XE Precision Temperature CyCling System Offers full mil-spec testing in a 120 volt benchtop unit. Stone Ridge, NY February 1, 2005 Contact: Bill Hanna 617.696 READ MORE
http://www.ftssystems.com/airjet0205.htm

Freeze-Dryers Particle Monitoring Requirements, 2003
Votes:20 Comments:0
Freeze-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 READ MORE
http://www.pmeasuring.com/particleCounting/appNotes/pharmaceutical/doc...

Cardinal Health?s Pharmaceutical Technologies & Services Group: Integrating Prop...
Votes:21 Comments:0
Cardinal Health?s Pharmaceutical Technologies & Services Group: Integrating Proprietary Technologies & Expert Services to Accelerate Product Development Not Dated Drug Delivery Technology The drug READ MORE
http://www.drugdeliverytech.com/cgi-bin/articles.cgi...

Optimizing cultural conditions of measles vaccine working seed lot with orthogon...
Votes:7 Comments:0
Optimizing cultural conditions of measles vaccine working seed lot with orthogonal experiments By: Chen T, Chen P, Jia W, Liu Y, Jiang R, Peng W, Shi D. - Microbiology Department, West China School READ MORE
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi...

GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS
Votes:37 Comments:0
GUIDE 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 READ MORE
http://www.fda.gov/ora/inspect_ref/igs/subst.html

Process Validation: Successes and Failures on Inspection
Votes:12 Comments:0
Process 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 READ MORE
http://www.fda.gov/cber/summaries/wcbp011005mm.pdf

Compliance Program Guidance Manual - Inspection of Biological Drug Products - 73...
Votes:3 Comments:0
Compliance Program Guidance Manual - Inspection of Biological Drug Products - 7345.848 BACKGROUND CBER-regulated biological drug products include fractionated blood and their recombinant analogues; READ MORE
http://www.fda.gov/cber/cpg/7345848.htm

Guidance for Industry: Drug Product Chemistry, Manufacturing, and Controls Infor...
Votes:36 Comments:0
Guidance for Industry: Drug Product Chemistry, Manufacturing, and Controls Information This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this READ MORE
http://www.fda.gov/cber/gdlns/drugcmc.pdf

The rules governing medicinal products in the European Union
Votes:35 Comments:0
The 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 READ MORE
http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol5/Vol5en.pdf

Lyophilization Processes: A Compliance/ Enforcement Perspective
Votes:27 Comments:0
Lyophilization Processes: A Compliance/ Enforcement Perspective January 25, 2005 By Anne Johnson International Society of Lyophilization, Delaware Valley Chapter Organizational Structure of FDA Co READ MORE
http://www.islyophilization.org/Html/Local_Chapters/Delaware_Valley/Ly...

Process Analytical Technology
Votes:21 Comments:0
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 READ MORE
http://www.fda.gov/Cder/OPS/PAT.htm

Good Manufacturing Practices (3rd Edition)
Votes:16 Comments:0
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 READ MORE
http://www.mindbranch.com/prod-toc/Good-Manufacturing-Practices-R294-2...
Regulatory Issues - Lyophilization
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