• 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

2018-05-02

MHRA five-year Corporate Plan 2018-2023

On Tuesday, 27/4/2018, MHRA (Medicines and Healthcare products Regulatory Agency) published is five-year Corporate Plan for 2018 - 2023.

 

“There are big changes ahead, not least the impact of the UK’s exit from the EU, but I am confident that the Agency, with its globally unique concentration of expertise in data, standards and regulation will continue to offer our customers a full range of services an d products which is not replicated anywhere else in the world”, Sir Michael Rawlins GBE Chairman of MHRA, said.

The three centres – the Clinical Practice Research Datalink, the MHRA regulator, and the National Institute for Biological Standards and Control – bring together expertise and evidence so that:

  • clinical practice is informed by and contributes to regulatory evidence;
  • global standards are underpinned by and enhance regulation; and
  • real world data additionally underpins regulation.

The combination of these should bring real benefit to patients across the UK, enabling the Agency to protect public health and to improve lives.

The MHRA’s opportunity through this new 5-year Corporate Plan, particularly in the context of the UK’s exit from the EU, will be to:

  • build further on the unique offer to the UK and international customers;
  • set out the ambitions on the added value which the Agency brings to improving public health; and
  • highlight the Agency’s contribution to delivering the Government’s Life Sciences agenda, notably in clinical trials, accelerated product licensing and emerging areas like genomics and advanced therapies.

This plan, then, sets direction on what the Agency will do over the next five years, to address proactively the uncertainties they face. It positions the MHRA to be agile to meet the changes that lie ahead and to continue to deliver innovative science and first-class research.

Source:

MHRA Corporate Plan

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