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If you’d like to be regularly informed on the latest developments in Good Manufacturing Practices


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GMP Inspections in Europe: Proven Strategies on How to Prepare

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TOP 5 GMP Downloads

1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


>>> Click here to find more Downloads!

News about GMP/cGMP


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.


EDQM recently published Supplement 6.6. Get a quick overview of the contents with the table of contents.


The U.S. Food and Drug Administration (FDA) today announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process.


Endotoxin Testing and Sterility Testing at the end of shelf-life. Requirements and answers to questions of the EMEA Quality Working Party, Inspections section.

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