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USP’s Role in Biologics – One Quality Standard ...

USP’s Role in Biologics – One Quality Standard, Regardless of Market Entry Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology

From:http://www.nabp.net/system/redactor_assets/documents/506/Morris.pdf

Specificity and Robustness Tests Added to Sievers TOC ...

Fact Sheet GE Power & Water Water & Process Technologies Analytical Instruments, Inc. Overview In a regulated pharmaceutical environment, instru-

From:http://www.geinstruments.com/GetLibraryDoc.aspx?id=dfa59b0e-94c6-4232-8b...

Guidelines - World Health Organization

Title: Guidelines Subject: WHO template and recommendations Author: Anne Guilloux Keywords: communication, photos, text Last modified by: Owner Created Date

From:http://apps.who.int/prequal/trainingresources/pq_pres/...

Guidance for Industry - Food and Drug Administration

Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution ...

From:http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070636.pdf

The Antimicrobial Efficacy Test, GMP and Investigations ...

The Microbiology Network; The Purpose of the Compendial Test The USP Antimicrobial Effectiveness Test (AET) is a product quality test which is designed to …

From:http://www.americanpharmaceuticalreview.com/.../144242-The-Antimicrobial...

ARCHIVED - Product Licensing Guidance Document, Version 2 ...

2.1 Compendial Applications. Section 6 of the Regulations outlines the time limitation for a compendial product licence application. Part 1: Product Licences

From:http://www.hc-sc.gc.ca › … › Legislation & Guidelines › Guidance Documents

PMF Newsletter 1003 v101019 - The Microbiology Network ...

Pharmaceutical Microbiology Forum Newsletter – Vol. 16 (3) Page 2 of 14 vide information on, give definition to, or describe a particular subject.

From:http://www.microbiologyforum.org/content/file/PMFNews.16.03.1003.pdf

The BPE 2012 Edition &“Project - ISPE Boston

2 What is ASME BPE? Why is it Important? BPE = BioProcessing Equipment Standard 3 ASME BPE Scope • To define the requirements of the bioprocessing,

From:http://www.ispeboston.org/files/asme_bpe_hanselka_foley.pdf

EP BP USP 2010 - QUALITY PIONEERS

2010 Pharmaceutical Reference Materials and Proficiency Testing Programs USP EP Pharmacopée Française Japanese Pharmacopeia Refractive Index Enzymes Substrates

From:http://www.qualitypioneers.ir/images/Reference%20Materials/RT%20Pharma.pdf

Pharmaceutical Sciences - Questions and Answers

Pharmaceutical Sciences - Questions and Answers. Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint …

From:http://www.hc-sc.gc.ca › … › Chemical Entity Products/Quality

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