• 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

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

2018-01-09

India reports quality shortcomings of Chinese pharma companies

The Economic Times of India has published an article saying that the Indian government has issued showcause notices to eight Chinese pharmaceutical companies. Those companies were inspected by a special Indian inspection team and were found to supply poor quality APIs to drug manufacturers in India.

 

The eight Chinese companies who could be blacklisted by the Drug Controller General of India (DCGI) are

  • M/S Qilu Tianhe Pharmaceuticals,
  • M/S Hinan Xinxiang Pharmaceuticals,
  • M/S Guangzhao Baiyunshan Pharmaceuticals,
  • M/S Shouguang Fukang Pharmaceuticals,
  • M/S Qilu Antibiotics (Linyi) Pharmaceuticals,
  • M/S Qindao Brightmoon Seawoods and
  • M/S Shanghaoi Xiandia Hasen (Shangqiu) Pharmaceuticals.

As these companies are supplying a big part of the overall raw material imported to India, imposing restrictions against them could result in a shortage of medicines in India. 70 % of the overall raw material comes from China, mostly due to the fact that it is four times cheaper than those produced in India. The Indian government has meanwhile also decided to inspect APIs imported from other countries such as the United States, Italy and other European nations.

Source:

Economic Times of India

Comments
No comment has yet been written about this news.