• 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 "Save Drugs through Better GMP Understanding".


GMP Compliance Adviser (formerly GMP MANUAL)

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

 

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

 

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

 

4. The New USP <1231>: Water for Pharmaceutical Purposes
A detailed overview

 

5. GMP Compliance Basics of Packaging Materials and Processes
Are you on top of the best practices you need to design and create your packaging correctly — every time?

 

>>> More Downloads

News about GMP/cGMP

2017-07-11

Swissmedic: Implementing of the Therapeutic Products Act Packet IV

As a result of the revised Swiss Therapeutic Products Act of March 2016, the relevant ordinances also need to be comprehensively adjusted. This affects ordinances issued both by the Federal Council and the Agency Council of Swissmedic and will last until October 2017.

 

Individual provisions (national recommendations on off-label dosages of paediatric medicinal products, or definitive arrangements for medicinal products approved by cantons) and the corresponding ordinance terms will enter into force ahead of schedule at the beginning of 2018. The Federal Council is conducting a consultation procedure for most of the implementing provisions (Therapeutic Products Ordinance Package IV), which are scheduled to apply from 2019.

The Ordinary Revision of the Therapeutic Products Act (Stage 2) is part of the Confederation's master plan for strengthening biomedical research and technology and aims at

  • Facilitating the access to medicines through simplyfing the authorisation of certain medicinal product categories
  • Improving drug safety by adapting to international developments
  • Promoting medicines for children by introducing a incentive system for the pharmaceutical industry. This could help to promote the development of paediatric medicines.
  • Increasing of transparency, e.g. through the publication of additional information on medicinal products submitted for assessment or their marketing authorisation holders.
Source:

Swissmedic: News

Comments
No comment has yet been written about this news.