• gmp-verlag.de
  • GMP Compliance Adviser 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

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

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".


TOP 5 GMP Downloads

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


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


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


4. A Pharma Guide to Cleaning Validation
How to meet Agency Expectations and Establish Accepted Limits.


5. Data Integrity in the EU
Requirements for Quality Management Systems.


>>> More Downloads

News about GMP/cGMP

2016-10-21

FDA: Warning Letters for European Drug Manufacturers

Not only China and India are in the focus of the US FDA when it comes to GMP non-compliance. Recently the FDA has released warning letters for cGMP violations identified in Scotland, the Netherlands and Switzerland.

 

At the manufacturing site of Laboratoire Sintyl SA in Geneva, FDA uncoverd six serious cGMP-violations according to 21 CFR 211, including

  • the failure to test “finished batches for the identity and strength of active ingredients“,
  • the failure to clean and maintain the equipment and
  • the lack of an established written procedure for "production and process controls, including validation protocols and reports, designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess“.

In another Warning Letter that went to the Dutch company Delarange Cosmetics & Healthcare BV , FDA criticized the failure to “establish and follow written procedures for cleaning and maintenance of equipment”. Additionally FDA uncovered, that no quality control unit for drug release was established.

To Scotland-based Wallace Cameron  International the Agency wrote: “Our records indicate that you have not registered your establishment for 2016, but have continued to manufacture, prepare, propagate, compound, or process drugs that were not listed but being imported or offered for import into the United States during this time.” In this context they did not mention which drug has been imported to the US.

 

Source:

FDA: Warning Letters

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