• 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 "Safe 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. 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>.


>>> More Downloads

News about GMP/cGMP

2017-09-08

CDRH Releases Eight Warning Letters for Device Manufacturers From Around The World

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.

 

US Warning Letters were sent to:

  • SyncThink, who was warned for marketing an eye impairment device without being able to show any corresponding clearance or approval
  • Steiner Biotechnology, who received a warning letter for disturbing federal regulations in the process of clinical studies
  • Entellus Medical diverged from clinical trial protocols in a study.

Various countries:

Source:

CDRH: Warning Letters

Comments
No comment has yet been written about this news.
 
 
Literature recommendation
GMP Compliance Adviser
Single User Licence (yearly subscription)