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The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview


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On 7 June 2016 Maas & Peither GMP Publishing has received a

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TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.

2. GDP Audit Checklist
More than 700 questions with reference to regulations.

3. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.

4. Industry Guide to handle OOX Test Results
Every single step of the OOX process.

5. The New USP <1231>: Water for Pharmaceutical Purposes
A compact overview of the contents of the new version of USP <1231>.

>>> More Downloads

News about GMP/cGMP


The focus is in this guideline is on physical chemical identifiers.


The European Medicines Agency has published its annual report for 2008, a highly productive year in which the Agency consolidated its work in core activity areas and made good progress with many of the initiatives it is involved in.


Revision to a Community procedure and a new procedure for dealing with serious GMP non-compliance are published


Download the Inactive Ingredients file from the FDA website.


The Division of Drug Information (DDI) is CDER's focal point for public inquiries. It serves the public by providing information on human drug products and drug product regulation by FDA.


FDA published on June 29, 2009, a new addendum to the "Guidance for Industry: Questions & Answers on Current Good Manufacturing Practices (cGMP) for Drugs".


Health Canada published its reviewed guidelines to Good Manufacturing Practice. They come into ...


At the Business Reception of Maas & Peither America in King of Prussia Paolomi Mukherji, Clarkston Consulting, held an interesting presentation about current GMP regulations and the latest changes of the US-FDA.


The following questions were asked:


EMEA published June 29, 2009, four annexes to the ICH Q4B "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions".


FDA already publised this document on its website. Now EMEA also adopted this helpful document.

EMEA´s Questions & Answers to ICH Q8, Q9, Q10


FDA published on June 26, 2009 the Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices


For those which were interested and were unable to attend the public meeting of the Transparency Task Force - the FDA has made the meeting viewable via webcast.


RAPS (Regulatory Affairs Professionals Society), Rockville, MD, is the new Sales Partner of Maas & Peither America, Inc.


European Medicines Agency launches public consultation on new transparency policy.

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