• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

>>> ORDER NOW

Award for the
GMP Compliance Adviser

GMP knowledge that convinces.

Image

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

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

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


GMP Compliance Adviser

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

Image

>>> READ MORE

TOP 5 GMP Downloads

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

 

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

 

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

 

4. The New USP <1231>: Water for Pharmaceutical Purposes
A detailed overview

 

5. GMP Compliance Basics of Packaging Materials and Processes
Are you on top of the best practices you need to design and create your packaging correctly — every time?

 

>>> More Downloads

News about GMP/cGMP

2017-11-21

The city to host the new headquarter of the European Medicines Agency EMA is chosen. Amsterdam emerged as the winner ahead of Milan and Copenhagen, the two other cities that reached the second and final round.

 
2017-11-15

In July 2017 the German Federal Ministry of Health (BMG) entered into a sponsoring contract with Maas & Peither GMP Publishing. From now on, the BMG will involve GMP Publishing in the official translation of the EU GMP Guide and its annexes.


 
2017-11-08

The German Federal Ministry of Health “Bundesministerium für Gesundheit, BMG” has published the official German translation of Annex 16: Certification by a Qualified Person and Batch Release, which is part of the EU GMP Eudralex Volume 4 GMP guidelines.

 
2017-11-08

A draft of the monography to Purified Water was published in the European Pharmacopoeia, which includes a new section on Elemental Impurities:

 
2017-11-02

As of 1 November 2017, the Mutual Recognition Agreement (MRA) between the European Union and the United States enters the operational phase. The MRA, which will allow to recognise inspections of manufacturing sites for human medicines conducted in each partners’ respective territories shall update the agreement dating back to 1998.

 
2017-10-18

On 16 October 2017, the EMA (European Medicines Agency) has published its 17-page Business Preparedness Plan to ensure continuity of the Agency’s operations once the United Kingdom is no longer a member country of the European Union.

The plan identifies three main priorities:

  • Not to jeopardise EMA’s positioning in the pharmaceutical arena in the post-Brexit era.
  • In parallel, to demonstrate its preparedness for addressing any emerging consequences by taking decisive and timely action when needed.
  • To provide a balanced communication and full transparency, both internally and externally.
 
2017-10-11

According to Swissmedic, the new Article 64a of the revised Therapeutic Products Act (revTPA) will already enter into force on 1 January 2018. This Article governs cross-border inspections and includes inspections carried out in Switzerland by foreign authorities, as well as inspections by Swiss authorities abroad.

 
2017-10-05

Between 12 and 19 September 2017, authorities around the world targeted the illicit online sale of medicines and medical devices. More than 123 countries took part in Operation PANGEA X which led to a record number of 25 million illicit and counterfeit medicines seized worldwide.

 
2017-09-26

The European Medicines Agency EMA has clarified its process for lifting a GMP non-compliance statement. The new process is outlined in an update to the question and answer document on GMP of the EMA.

 
2017-09-19

On September 11, 2017, Michael Kopcha, Ph.D., R.Ph. and FDA’s director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER), announced the opening of a public docket to seek input from experts in areas of science, technology and best practices concerning “Continuous Manufacturing”. To establish common guiding principles to this new technology shall help to push this production method forward.

 
2017-09-19

PIC/S: Three New Participating Authorities
Swissmedic: Combat Against Illegal Pharmaceuticals

 
2017-09-08

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) published a whole new round of warning letters. They are addressed to three manufacturers from the US and five in Brazil, the Netherlands, Germany, China and Bulgaria.

 
2017-09-08

According to the ICH (International Council for Harmonisation), the ICH Q11 Q&A reached Step 4 of the ICH process in August 2017. The document is now entering Step 5 – the implementation period.

 
2017-09-05

The British Medicines and Healthcare products Regulatory Agency (MHRA) is dealing with the outcome of the EU referendum to move things into the right direction for the post-Brexit period.

On 21 August 2017, a position paper on the “Continuity in the availability of goods for the EU and the UK” was published by the MHRA that clearly states the desire for a smooth and orderly withdrawal from the EU, one that avoids any disruption for business and consumers. According to the British Regulator Authority, to move to the freest possible future economic relationship should be the goal.

 
2017-08-29

The European Medicines Agency EMA, the European Commission and the US FDA have signed a new confidentiality commitment. It enables US and EU regulators to share non-public and commercially confidential information, including trade secret information relating to medicine inspections.

 
 
Page 1/39    1   2   3   4   5   6   7   8   9   10