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2017 - The GMP Regulations Report

Have you considered all last years new regulations?

Make sure you did not miss out on one or the other with our overview of 24 important GMP documents published in 2017.


>>> Read now:
2017-Regulations-Report.pdf

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.

 

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

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

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


TOP 5 GMP Downloads

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


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


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


4. A Pharma Guide to Cleaning Validation
How to meet Agency Expectations and Establish Accepted Limits.


5. Data Integrity in the EU
Requirements for Quality Management Systems.


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News about GMP/cGMP

2018-08-10

EMA reported, that it will lauch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.

 
2018-08-03

The MedTech Europe industry group calls on the European institutions to offer solutions to meet the deadlines for the new MDR and IVDR. Both regulations will apply from May 2020 and May 2022 respectively.

 
2018-08-03

The World Health Organization (WHO) has prepared a new questions and answers document to clarify earlier biosimilar guidelines. It will provide answers to questions asked by regulators over the last eight years.

 
2018-07-20

The European Union and Japan have extended their Mutual Recognition Agreement (MRA) on 18 July 2018. The MRA now also includes sterile products, APIs and biologicals including vaccines.

 
2018-07-20

On 17 July 2018, the Members of the British Parliament voted 305-301 to continue a close collaboration with the EMA after Brexit. This amendment to the Brexit Trade Bill on ‘UK participation in the European medicines regulatory network’ means that British Government is now 'in charge' to negotiate an active and full participation in the EMA following the United Kingdom’s exit from the EU.

 
2018-07-13

The European Medicines Agency EMA expresses “serious concerns” over the preparedness of some marketing authorisation holders for centrally authorised products with an important step in their regulatory processes in the United Kingdom (UK) regarding the necessary actions to smoothly transition once the UK will exit the EU in March 2019. This conclusion was drawn after evaluating the results of an industry survey which was initiated by the Agency in January 2018 (we reported).

 
2018-07-05

The ICH (International Council for Harmonisation) met in Kobe, Japan, from June 2 – 7, 2018. The corresponding press release provides insight on the topics discussed.

 
2018-07-05

The US FDA initiated two new programs on a voluntary basis to gather industry feedback regarding the use of quality metrics. Namely these are a

  • Quality Metrics Feedback Program and a
  • Quality Metrics Site Visit Program.
 
2018-06-29

The European Commission has now published the final version of Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use". It is in operation since 26 June 2018.

 
2018-06-29

Almost two years after publishing a draft document of Annex 17: Real Time Release Testing the European Commission has now published the final version newly entitled Annex 17: Real Time Release Testing and Parametric Release. The eight-page document will come into operation on 26 December 2018 and will finally replace the preceding version of the year 2002.

 
2018-06-29

On 26 and 27 June 2018, the PDA Europe Annual Meeting took place in Berlin. Thomas Peither, Excecutive Editor and President of Maas & Peiter AG, participated in the conference and brought back interesting insights.

 
2018-06-22

On 19 June 2018 the European Medicines Agency (EMA) published

  • Revision 2 of its practical guidances for procedures related to Brexit for medicinal products for marketing authorisation holders (MAH) and
  • Revision 3 of the related Q&A document.
Both documents shall assist pharmaceutical manufacurers in preparing for Brexit.
 
2018-06-22

The following new PIC/S Guidance documents have now been published on the PIC/S website:

 
2018-06-15

The US FDA is currently alerting patients, health care professionals and those involved in the drug supply chain of more than 16,000 packages of the injectable fertility medications Gonal-f RFF Redi-ject and Gonal-f Multi-Dose that have been stolen in Italy.

 
2018-06-15

With the publication of the 52nd Technical Report Series No. 1010 of the WHO, eleven Guidelines were adopted and recommended for use:

 
 
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