• 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

2017 - The GMP Regulations Report

Have you considered all last years new regulations?

Make sure you did not miss out on one or the other with our overview of 24 important GMP documents published in 2017.


>>> Read now:
2017-Regulations-Report.pdf

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

2016-12-13

FDA: Warning Letter for Spanish API Manufacturer

The US FDA (Food and Drug Administration) released a warning letter sent to Interquim S.A., Barcelona, Spain. The drug manufacturing facility was inspected in May 2016. It summarizes significant deviations from current GMP for active pharmaceutical ingredients (APIs).

 

The warning letter lists the three following observed specific deviations:

  • Failure to have adequate cleaning procedures that define and justify acceptance criteria for residues.
  • Failure to construct equipment so that surfaces that contact raw materials, intermediates, or API do not alter the quality of API beyond established specifications.
  • Failure of the quality unit to ensure that there is stability data to support retest or expiry dates and storage conditions on API and/or intermediates.
FDA doesn’t consider this to be an “all-inclusive list”. Interquim is now responsible for investigating these deviations for determining the causes, for preventing their recurrence, and for preventing other deviations.

Source:
FDA: Warning Letter
Comments
No comment has yet been written about this news.
 
 
Literature recommendation
Managing Process Validation
Questionnaire for preparing GMP-inspections
GMP Compliance Adviser
Single User Licence (yearly subscription)