• 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

2018-10-05

CDRH publishes proposed Medical Device Guidance Development 2019

On 3 October 2018, the US FDA’s Center for Devices and Radiological Health (CDRH) has published three lists of guidance documents that may be published in 2019:

  • Prioritized medical device guidance documents that the Agency intends to publish in FY 2019 ("A-list")
  • Device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit, in FY 2019 ("B-list")
  • Previously-issued final guidances for which CDRH is interested in receiving feedback whether these final guidances should be revised or withdrawn (retrospective review list).
    This list includes documents which were  issued in 1989, in 1999 and in 2009.
 

CDRH calls for comments on any or all of the guidance documents on the three lists, specifically, on the relative priority of guidance documents. Comments should also include suggestions on the draft language on the proposed A-list and B-list topics and suggestions for new or different guidance documents. Those comments should include a statement of reasons. For the retrospective review list CDRH is seeking suggestions regarding which final guidances should be revised or withdrawn.

Source:

CDRH: Fiscal Year 2019 (FY 2019) Proposed Guidance Development

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