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GMP LOGFILE: Lead Article

LOGFILE No. 27/2018 – Pharmaceutical Industry Highlights - Past, Present, Future

02.07.2018

Pharmaceutical Industry Highlights - Past, Present, Future

A report on the PDA European Annual Meeting 2018 – Part 1

6 minutes reading time

by Thomas Peither

LOGFILE No. 26/2018 – Principles of Cleaning Process Requirements

22.06.2018

Principles of Cleaning Process Requirements

An excerpt from the GMP Series PDF Download A Pharma Guide to Cleaning Validation

6 minutes reading time

by Michael Hiob, PhD

LOGFILE No. 25/2018 – The clock is ticking on the new EU Medical Devices and In Vitro Diagnostic Devices Regulations

15.06.2018

The clock is ticking on the new EU Medical Devices and In Vitro Diagnostic Devices Regulations

10 minutes reading time

by Andrew Love

LOGFILE No. 24/2018 – GDP Questionnaire - Transportation

11.06.2018

GDP Questionnaire - Transportation

An excerpt from the GDP Questionnaire

5 minutes reading time

by Simone Ferrante

 

LOGFILE No. 23/2018 – PQ: The Link between Qualification and Validation

17.05.2018

PQ: The Link between Qualification and Validation

An excerpt from the GMP Compliance Adviser, Chapter 6.G  Performance Qualification

6 minutes reading time

by Thomas Peither, Ulrike Reuter, Rainer Röcker

LOGFILE No. 22/2018 – Data Integrity and the Problem of Getting It Done

16.05.2018

Data Integrity and the Problem of Getting It Done

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peithe

LOGFILE No. 21/2018 – Effectively Dealing with OOX Results

07.05.2018

Test results outside defined criteria (OOX)

An excerpt of the GMP Series Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger

LOGFILE No. 17/2018 – Layout of a Cleanroom Air Handling Unit

02.05.2018

Layout of a Cleanroom Air Handling Unit

 

An excerpt from the GMP Compliance Adviser, Chapter 3.I Air Handling Technology

 

6 minutes reading time

by Harald Flechl

LOGFILE No. 20/2018 – Practical Issues on Supply Chain and Good Distribution Practice

27.04.2018

Practical Issues on Supply Chain and Good Distribution Practice

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

6 minutes reading time

by Susanne Sailer

LOGFILE No. 19/2018 – 2017 - The GMP Regulations Report

19.04.2018

2017 – The GMP Regulations Report

by Sabine Rabus

LOGFILE No. 18/2018 – The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing

16.04.2018

The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither

LOGFILE No. 16/2018 – Industry 4.0 - Inspiration for the Pharmaceutical Industry?

09.04.2018

Industry 4.0 - Inspiration for the Pharmaceutical Industry?

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither

LOGFILE No. 15/2018 – Principles of Qualification

03.04.2018

Principles of Qualification

An excerpt from the GMP Series PDF Download Qualification and Validation: Agency Expectations

6 minutes reading time

by Michael Hiob, PhD

LOGFILE No. 14/2018 – Inspections & Audits: Pitfalls and Criteria for Success – Part 2

26.03.2018

Inspections & Audits: Pitfalls and Criteria for Success – Part 2

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

6 minutes reading time

by Sabine Rabus and Christine Gräßlin

LOGFILE No. 10/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 1

13.03.2018

What a Qualified Person must know about the recent cleaning validation updates – Part 1

6 minutes reading time

by Walid El Azab

LOGFILE No. 13/2018 – Inspections & Audits: Pitfalls and Criteria for Success – Part 1

12.03.2018

Inspections & Audits: Pitfalls and Criteria for Success – Part 1

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

4 minutes reading time

by Sabine Rabus and Christine Gräßli

LOGFILE No. 09/2018 – General principles of hygienic design

06.03.2018

General principles of hygienic design

An excerpt from the GMP Series PDF Download Applying the Principles of Hygienic Design to Solid Dosage Forms

8 minutes reading time

by Richard Denk

LOGFILE No. 12/2018 – Sampling Frequencies

05.03.2018

Sampling Frequencies

An excerpt from the GMP Series PDF Download Microbiological Monitoring in Pharmaceutical Manufacturing

6 minutes reading time

by Hanfried Seyfarth, PhD

LOGFILE No. 08/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2

27.02.2018

What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2

6 minutes reading time

A commentary by Ruven Brandes and Fritz Röder

LOGFILE No. 11/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 2

22.02.2018

What a Qualified Person must know about the recent cleaning validation updates – Part 2

6 minutes reading time

by Walid El Azab

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