• 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

2018-01-23

CDER List for Planned Guidance Documents in 2018

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.

 

Two documents are listed under the category „Pharmaceutical Quality/Manufacturing Standards (CGMP)“:

  • CGMP  Final  Interim  Guidance  for Human Drug Compounding  Outsourcing  Facilities Under Section  503B of the FD&C Act; Revised Draft
  • Field  Alert Report Submission

The category of “Pharmaceutical Quality/Microbiology” lists the

  • Microbiological  Considerations  for  Non-Sterile   Drug  Products

The related category „Pharmaceutical Quality/CMC” lists 13 additional guidances. If you are interested to take a look at these documents and the full list of guidances, please click here.

Source:

CDER: What's new related to drugs

Comments
No comment has yet been written about this news.