LOGFILE No. 18/2012 - GMP and Personalized Medicine
15.10.2013
GMP and Personalized Medicine
Author: Thomas Peither, Maas & Peither AG
LOGFILE No. 17/2012 - Transfer of qualification activities to suppliers
08.10.2013
Outsourcing qualification activities to suppliers
Authors: Ulrike Reuter, Germany; Max Lazar, USA
LOGFILE No. 13/2012 - Commenting on USP Standards
29.08.2013
The Importance of Commenting on Public Standards
Authors: Sue Schniepp, OSO Biopharmaceutical and Janeen Skutnik-Wilkinson, Pfizer
LOGFILE No. 12/2012 - Qualification of Personnel
27.08.2013
Aseptic Processing: Qualification of personnel
Author: Dipl.-Ing. (FH) Ruven Brandes, WDT eG, Germany
LOGFILE No. 11/2012 - GDPs for Excipients
07.08.2013
USP and IPEC-Europe Weigh in on GDPs for Excipients
An article by IPQ Publications
LOGFILE No. 09/2012 - Quality by Design (QdB)
24.07.2013
The New Quality Paradigm
Author: Dr. Siegfried Schmitt
LOGFILE No. 07/2012 - GMP Inspection of suppliers
17.07.2013
Inspection of suppliers
Authors: Dr. Michael Hiob, Max Lazar
LOGFILE No. 04/2012 - GMP Guidelines 2012
26.06.2013
GMP-Guidelines: What can we expect in 2012?
Author: Anita Maas, Maas & Peither AG
LOGFILE No. 03/2012 - Process Validation
11.06.2013
Process validation from the viewpoint of the FDA
Authors: Dr. Christine Oechslein, GMP Instructor, Germany and Max S. Lazar, FDA Regulatory Compliance Consulting, USA
LOGFILE No. 15/2011 - November 2011
06.05.2013
Which Risk Assessment fits best?
Authors: S. Roenninger, M. Hertlein
LOGFILE No. 14/2011 - November 2011
29.04.2013
Temperature Profiles
Author: Nicola Spiggelkötter Ph. D.
LOGFILE No. 09/2013 - An Introduction to PQR and APR
27.03.2013
Product Quality Review and Annual Product Review
By Dr. Christian Gausepohl