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GMP LOGFILE: Lead Article

LOGFILE No. 02/2016 – Intermediate bulk container systems

14.09.2015

Intermediate bulk container systems

An excerpt from the GMP Series PDF Download 
Technical Solutions for Personal Protection in Solid Drug Manufacturing

An excerpt from the GMP MANUAL

by Richard Denk

LOGFILE No. 01/2016 – 2016 - GMP in Production

14.08.2015

2016 – GMP in Production

by Thomas Peither

LOGFILE No. 48/2015 – Managing Outsourced GMP Activities Successfully

14.08.2015

Managing Outsourced GMP Activities Successfully

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher and Dr. jur. Ingo Schneider

LOGFILE No. 47/2015 – Transportation

14.08.2015

How do you transport and store medicinal products? Here is what you have to know!

by Dr. Sabine Paris

LOGFILE No. 45/2015 – Reasons for Outsourcing

10.08.2015

Reasons for Outsourcing

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher

LOGFILE No. 44/2015 – Organization of audits

07.08.2015

Organization of Audits

An excerpt of the GMP-Audit-Checklist

by Dr. Michael Hiob and Max Lazar

LOGFILE No. 43/2015 – Particle Monitoring

03.08.2015

Particle Monitoring

An excerpt from the GMP MANUAL

by Thomas von Kahlden

LOGFILE No. 42 / 2015 – How to deal with OOX Results

22.07.2015

Receiving the OOS result and starting the OOS process

An Excerpt from the GMP Series PDF Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger

LOGFILE No. 41/2015 – Checklist Performance Qualification

20.07.2015

Checklist Performance Qualification

An Excerpt from the GMP Series PDF Download The Ultimate Checklist for Premises and HVAC Qualification

by Dr. Hans H. Schicht

LOGFILE No. 40/2015 – The purpose of GMP

07.07.2015

The purpose of GMP

An excerpt of GMP Fundamentals

by Dr. Christine Oechslein

LOGFILE No. 39/2015 – Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

06.07.2015

Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Stefan Kettelhoit

LOGFILE No. 37/2015 – How to Manage Corrective and Preventive Actions

23.06.2015

How to Manage Corrective and Preventive Actions (CAPA) in GMP Environment

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Bernd Renger

What is quality management?

15.06.2015

What is quality management?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein

LOGFILE No. 35/2015 – GMP Inspection: Be Prepared when the Inspector Comes

08.06.2015

GMP Inspection: Be Prepared when the Inspector Comes

by Thomas Peither

LOGFILE No. 34/2015 – Risk Management in Transportation

29.05.2015

Risk Management in Transportation

An excerpt of the GMP MANUAL


by Dr. Nicola Spiggelkoetter

LOGFILE No. 32/2015 – Older Pharmaceutical Factories

27.05.2015

Older Pharmaceutical Factories – What does the FDA have to say?

by Thomas Peither

 

LOGFILE No. 30/2015 – Quality Metrics - Bane or Boon?

04.05.2015

Quality Metrics - Bane or Boon?

by Thomas Peither

LOGFILE No. 28/2015 - Risk Evaluation - more than just data and facts

28.04.2015

Risk Evaluation - more than just data and facts

An excerpt from the PDA/DHI publication Risk Assessment and Risk Management in the Pharmaceutical Industry - Clear and Simple

by James L. Vesper

LOGFILE No. 26/2015 - General principles of hygienic design

21.04.2015

General principles of hygienic design

An excerpt of the GMP MANUAL


by Richard Denk

LOGFILE No. 24/2015 - Cleaning Engineering: Flow and Coverage in Process Piping

13.04.2015

Cleaning Engineering: Flow and Coverage in Process Piping

An excerpt from the PDA/DHI publication Cleaning and Cleaning Validation

by George Verghese and Paul Lopolito

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