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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

Enzyme Unit assignment and Maintenance, Reference ...

BIPM and the International System of Units. In the International System of Units the derived SI unit for catalytic activity is the katal: kat = mol/s

From:http://www.usp.org/sites/default/files/usp_pdf/EN/meetings/workshops/...

EndoZyme® Frequently Asked Questions (FAQ) | Endotoxin ...

EndoZyme® Frequently Asked Questions (FAQ) Is EndoZyme® a valid alternative to the LAL assay? Yes, EndoZyme® is a valid alternative to the LAL assay.

From:http://www.endotoxin-test.com/endozyme-frequently-asked-questions-faq

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

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

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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