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GMP LOGFILE: Lead Article
LOGFILE Feature 46/2019 – Failure Management in a GMP Regulated Environment
10.12.2019
Failure Management in a GMP Regulated Environment
An excerpt from the GMP Series e-book Failure Management in a GMP Regulated Environment
5 minutes reading time
by Martin Mayer
LOGFILE Feature 45/2019 – Ventilation units, or the invisible energy in the clean room
03.12.2019
Ventilation units, or the invisible energy in the clean room
GMP-Talk with Harald Flechl at the LOUNGES 2018 in Karlsruhe
9 minutes reading time
by Doris Borchert, PhD
LOGFILE Feature 44/2019 – PDA/FDA Joint Regulatory Conference 2019
26.11.2019
PDA/FDA Joint Regulatory Conference 2019
6 minutes reading time
by Thomas Peither
LOGFILE Feature 43/2019 – Transfer of analytical procedures to the contract laboratory
19.11.2019
Transfer of analytical procedures to the contract laboratory
An excerpt from the e-book Managing Contract Manufacturers and Testing Labs and the online knowledge portal GMP Compliance Adviser
4 minutes reading time
by Frank Böttcher, PhD
LOGFILE Feature 42/2019 – In 8 steps to self-learning FMEA
12.11.2019
In 8 steps to self-learning FMEA
The alternative to the classic FMEA: FMEA according to Spengler and Juhnke
6 minutes reading time
by Felix Tobias Kern, PhD
LOGFILE Feature 41/2019 – New Toxicological Assessment Services of GMP Publishing
05.11.2019
New Toxicological Assessment Services of GMP Publishing:
Organic and Mutagenic Impurities / Environmental Risk Assessments (ERAs)
10 minutes reading time
by Sabine Paris, PhD
LOGFILE Feature 40/2019 – Batch release process steps
29.10.2019
Batch release process steps
An excerpt from the e-book EU-Compliant Batch Release of Medicinal Products
6 minutes reading time
by Rainer Gnibl, PhD
LOGFILE Feature 39/2019 – Sliding doors in clean rooms – "no go" or "best practice"?
22.10.2019
Sliding doors in clean rooms – "no go" or "best practice"?
A shortened and edited excerpt from the GMP Compliance Adviser, Chapter 3.E
7 minutes reading time
by Harald Flechl / Dr Doris Borchert (editorial editing)
LOGFILE Feature 38/2019 – Is there a legal requirement for the document language of GMP-relevant documents?
15.10.2019
Is there a legal requirement for the document language of GMP-relevant documents? In our company it is planned to write all documents in English. However, many employees do not speak English. Is there a rule that says that the documents must be "readable and understandable" for employees?
Your question - Our answer
4 minutes reading time
by Sabine Rabus
LOGFILE Feature 37/2019 – EDQM inspections and trends of deficiencies relating to API facilities
08.10.2019
EDQM inspections and trends of deficiencies relating to API facilities
10 minutes reading time
by Tim Sandle
LOGFILE Feature 36/2019 – Data integrity in the quality control laboratory
01.10.2019
Data integrity in the quality control laboratory
An excerpt from the GMP Compliance Adviser, Chapter 14.L.1 and the GMP Focus e-book Data Integrity in the EU
5 minutes reading time
by Markus Veit, PhD
LOGFILE Feature 35/2019 – Your E-Learning Trial Version
24.09.2019
Your E-Learning Trial Version
An excerpt from the GMP:READY – GMP for Engineers
2 minutes reading time
LOGFILE Feature 34/2019 – Passive transport packaging
17.09.2019
Passive transport packaging
An excerpt from the GMP Compliance Adviser, Chapter 24.J.3
5 minutes reading time
by Christoph Frick, PhD, and Nicola Spiggelkötter, PhD
LOGFILE Feature 33/2019 – Administration and control of substances
10.09.2019
Administration and control of substances
An excerpt from the new e-book Core Processes in the Pharmaceutical Laboratory
3 minutes reading time
by Markus Limberger, PhD
LOGFILE Feature 32/2019 – GDP - DIN SPEC 91323: Uniform testing standards for vehicles used for the transport of pharmaceuticals
03.09.2019
GDP - DIN SPEC 91323: Uniform testing standards for vehicles used for the transport of pharmaceuticals
A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018
12 minutes reading time
by Sabine Rabus
LOGFILE Feature 31/2019 – Zone concept and clean room classes
27.08.2019
Zone concept and clean room classes
An excerpt from the step-by-step guide GMP Fundamentals
6 minutes reading time
by Christine Oechslein, PhD
LOGFILE Feature 29/2019 – Optimum GMP training concept: modular and inclusive e-learning
30.07.2019
Optimum GMP training concept: modular and inclusive e-learning
8 minutes reading time
by Christine Oechslein, PhD
LOGFILE Feature 27/2019 – Pharmacopoeias in the context of quality control
16.07.2019
Pharmacopoeias in the context of quality control
An excerpt from the GMP Compliance Adviser, Chapter 14.K.2
4 minutes reading time
by Markus Veit, PhD