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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

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 "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.


>>> More Downloads

News about GMP/cGMP

2018-01-30

The European Medicines Agency (EMA) has launched a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

 
2018-01-23

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to release in 2018. A total of 98 planned guidance documents have been set out which are categorised in 18 different themes.

 
2018-01-19

This week the US FDA (Food and Drug Administration) has already released five warning letters, all dealing with significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and APIs. Following is a short summary of the various findings:

 
2018-01-15

Swissmedic has announced that as of now, the foreign comparator product with a biosimilar for the main studies can also originate from the USA, while that for supplementary studies can now also originate from Canada.

 
2018-01-09

The Economic Times of India has published an article saying that the Indian government has issued showcause notices to eight Chinese pharmaceutical companies. Those companies were inspected by a special Indian inspection team and were found to supply poor quality APIs to drug manufacturers in India.

 
2017-12-21

On 20 December 2017 the European Commission has published the long awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products”. The public consultation period is open from 20 December until 20 March 2018.

 
2017-12-20

Three years after the publication of a concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”, the ICH has now published the Step 2 draft document including an Annex with illustrative examples. The document was endorsed on 16 November 2017.

 
2017-12-12

The EMA (European Medicines Agency) and the European Commission have published an updated version of the Q&A document which is intended to help the pharmaceutical industry to organise the UK’s withdrawal from the EU for their company.

 
2017-12-01

On 24 November 2017, the European Medicines Agency has published a practical guidance document on post-Brexit Changes. The Practical Guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure comes in the form of nine questions and answers and outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisation.

 
2017-11-29

On 24 November 2017, the European Commission has published the final version of the Guidelines on GMP specific to Advanced Therapy Medicinal Products. The term “Advanced Therapy Medicinal Products” (ATMPs)  is used to designate gene therapies, somatic cell therapies and tissue engineered products.

 
2017-11-29

According to the Swiss Federal Office of Public Health FOPH, Switzerland is revising its medical devices legislation, closely modelled on the various new EU requirements aiming at an improvement on the safety and quality of medical devices.

 
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.

 
 
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