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

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The GMP MANUAL (now: GMP Compliance Adviser) impressed the jury with "Safe Drugs through Better GMP Understanding".


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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>.


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News about GMP/cGMP

2009-08-14

Baxter International (Deerfield, IL), sanofi aventis (Paris), and Novartis (Basel, Switzerland) provided updates last week of their production and regulatory activities relating to preparedness in supplying the A(H1N1) pandemic influenza vaccine. Novartis also outlined its activities for providing seasonal flu vaccines.

 
2009-08-13

Commissioner of Food and Drugs Margaret A. Hamburg, M.D., today outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations.

 
2009-08-11

Come and meet Thomas Peither, President of Maas & Peither America, Inc. in person at the 2009 PDA/FDA Joint Regulatory Conference in Washington, D.C. (September 2009).  

 

 
2009-08-10

 At its plenary meeting on 19 March 2009, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted its 2010 priorities for drug safety research based on recommendations from the CHMP’s Pharmacovigilance Working Party.

 
2009-08-07

FDA Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM) published today a new Guidance for Industry: "Pharmaceutical Components at Risk for Melamine Contamination"

 
2009-08-06

The next update of the GMP MANUAL the most powerful cGMP knowledge base is announced for late September 2009. Read about the content on our UPDATE WEBPAGE

Link to GMP MANUAL Update No. 07

 
2009-08-05

Following the launch of a new version the EudraGMP database is now providing public access to information about manufacturing, importation authorisations and Good Manufacturing Practice (GMP) certificates.

 
2009-08-04

Question: What is the basis for the calculation of thresholds to set limits for impurities in the finished product specification?

 
2009-08-04

Collaborative effort aims to ensure appropriate conduct of clinical trials. Initiative pilot phase starts on 1st of September 2009. Is this a starting point for further initiatives between FDA and EMEA also in the GMP area?

 
2009-08-03

Company fails to adhere to current Good Manufacturing Practice regulations.

 
2009-07-31

As of today the new website of Maas & Peither GMP Publishing is online. You will now get more & better information than before. Click on "read more" to learn more about the new features.

 
2009-07-29

On July 22, 2009, FDA published a warning letter concerning cGMP deviations to the medical device manufacturer Ohio Medical Corp. The warning letter is referencing to the FDA Good Manufacturing Practices for medical device manufacturer 21 CFR 820.

 
2009-07-29

ICH Quality Implementation Working Group on Q8/Q9/Q10 updated the Questions & Answers document July 23, 2009.  Changes were made in Question #7 of the section 2.2 Real Time Release Testing: "If RTR testing results fail or trending toward failure, can end product testing be used to release the batch?"

 
2009-07-28

FDA Center of Biologic Evaluation and Research (CBER) published today the new Guidance for Industry: "Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products"

This guidance finalizes the draft guidance of the same title, dated July 2008.

 
2009-07-24

Guideline on Data Requirements for the Replacement of established Master Seeds (MS) already used in authorised Immunological Veterinary Medicinal Products (IVMPs) by new Master Seed of the same origin. Coming into effect February 1, 2010.

 
 
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