• 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

2018-06-08

ICH Q3D: Public Consultation on Cadmium Inhalation PDE Level

The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period. The revision is focused on an error correction in the calculation of the Cadmium inhalation Permitted Daily Exposure (PDE) level.

 

The Expert Working Group re-evaluated the data supporting the Cadmium inhalation PDE and concluded that a modifying factors approach, similar to that used for calculating the oral and parenteral PDEs, was appropriate for the inhalation PDE. The corrected value resulted in 3.4 μg/day.

Cadmium (Cd)

 

Oral

Parenteral

Inhalation

PDE (μg/day)

5.0

1.7

3.4

 

Comments on the ICH Q3D(R1) draft revision document can be entered by e-mail to the ICH Secretariat. More details can be found under the Public Consultation page.

Source:

ICH: Newsroom

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