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GMP LOGFILE: Lead Article
LOGFILE No. 19/2012 - Site Master File (SMF)
Site Master File – Guidelines for structure, contents and extent
Author: Cornelia Wawretschek, GxP Services
LOGFILE No. 18/2012 - GMP and Personalized Medicine
GMP and Personalized Medicine
Author: Thomas Peither, Maas & Peither AG
LOGFILE No. 17/2012 - Transfer of qualification activities to suppliers
Outsourcing qualification activities to suppliers
Authors: Ulrike Reuter, Germany; Max Lazar, USA
LOGFILE No. 15/2012 - GMP Risk Analysis RA 2x5
Risk Analysis RA2x5
Author: Thomas Peither
LOGFILE No. 14/2012 - EMA Draft for Process Validation
EMA Draft for Process Validation
Author: Thomas Peither
LOGFILE No. 13/2012 - Commenting on USP Standards
The Importance of Commenting on Public Standards
Authors: Sue Schniepp, OSO Biopharmaceutical and Janeen Skutnik-Wilkinson, Pfizer
LOGFILE No. 12/2012 - Qualification of Personnel
Aseptic Processing: Qualification of personnel
Author: Dipl.-Ing. (FH) Ruven Brandes, WDT eG, Germany
LOGFILE No. 11/2012 - GDPs for Excipients
USP and IPEC-Europe Weigh in on GDPs for Excipients
An article by IPQ Publications
LOGFILE No. 09/2012 - Quality by Design (QdB)
The New Quality Paradigm
Author: Dr. Siegfried Schmitt
LOGFILE No. 07/2012 - GMP Inspection of suppliers
Inspection of suppliers
Authors: Dr. Michael Hiob, Max Lazar
LOGFILE No. 06/2012 - Monitoring of HVAC systems
Monitoring of HVAC Systems
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Objectives of process monitoring
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Data management stipulations
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Air cleanliness and other room air data
Author: Dr. Hans Schicht
LOGFILE No. 04/2012 - GMP Guidelines 2012
GMP-Guidelines: What can we expect in 2012?
Author: Anita Maas, Maas & Peither AG
LOGFILE No. 03/2012 - Process Validation
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. 1/2012 - January 2012
Contract Manufacture: Duties of the Contract Giver
from Max S. Lazar
LOGFILE No. 15/2011 - November 2011
Which Risk Assessment fits best?
Authors: S. Roenninger, M. Hertlein
LOGFILE No. 14/2011 - November 2011
Temperature Profiles
Author: Nicola Spiggelkötter Ph. D.
LOGFILE No. 09/2013 - An Introduction to PQR and APR
Product Quality Review and Annual Product Review
By Dr. Christian Gausepohl
LOGFILE No. 2/2013 - Improve Quality Systems
Simplification Can Improve Quality Systems, Experts Say Part I
Rebecca Stauffer, PDA