• 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!


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:

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.




Award for the
GMP Compliance Adviser

GMP knowledge that convinces.


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


FDA: Final Guidance on CGMP for Combination Products

The US Food and Drug Administration released a 59-page final guidance on the CGMP requirements for combination products. The guidance describes and explains specific provisions from 21 CFR Part 4 (final rule on CGMP for combination products) that was released in 2013. A draft version of this document was issued in January 2015.


21 CFR Part 4 did not establish any new requirements but clarified which CGMP requirements apply when drugs, devices and biological products are combined to create combination products.

This final guidance to 21 CFR Part 4

  • applies to all combination products
  • provides a definition of “combination product” according to FDA
  • gives an overview of 21 CFR Part 4
  • describes the role of the lead center and other Agency centers (e.g. CDER, CBER, CDRH)
  • addresses certain general considerations for CGMP compliance for combination products
  • presents the purpose and content of specific CGMP requirements addressed in 21 CFR Part 4
  • analyzes hypothetical scenarios that illustrate how to comply with certain requirements for specific types of combination products (for a prefilled syringe, drug-eluting stent and drug-coated mesh)
  • refers to a “CGMP operating system” meaning the operating system within an establishment designed and implemented to address and meet the CGMP requirements for manufacturing a combination product
  • clarifies how to deal with constituent parts of cross-labeled combination products
  • explains the two ways to demonstrate compliance
    - a streamlined approach
    - a CGMP/QS approach
  • addresses the documentation needed for a CGMP approach.

For more details please refer to the original guideline.


FDA: CGMP Requirements for Combination Products

No comment has yet been written about this news.