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

 

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

 

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

 

4. The New USP <1231>: Water for Pharmaceutical Purposes
A detailed overview

 

5. GMP Compliance Basics of Packaging Materials and Processes
Are you on top of the best practices you need to design and create your packaging correctly — every time?

 

>>> More Downloads

News about GMP/cGMP

2017-06-28

FDA: Draft Q&A to Electronic Records and Signatures in Clinical Investigations – 21 CFR 11

 

The document includes 28 questions and answers which discuss, inter alia, the following:

  • Procedures, that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and that the records and signatures are considered  trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper
  • The use of risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations.
The Q&A document aims at encouraging and facilitating the use of electronic records and systems to improve the quality and efficiency of clinical investigations. It is intended for sponsors, clinical investigators, institutional review boards and contract research organisations (CROs).

Quelle:
FDA: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Q&A
Comments
No comment has yet been written about this news.
 
 
Literature recommendation
GMP Compliance Adviser
Single User Licence (yearly subscription)