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GMP LOGFILE: Lead Article
LOGFILE Feature 42/2019 – In 8 steps to self-learning FMEA
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
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
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"?
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?
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
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
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
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
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
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
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
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
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
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
LOGFILE Feature 26/2019 – GMP and GDP Activities in Storage Areas
GMP and GDP Activities in Storage Areas
An excerpt from the new e-book Storage of Medicinal Products
4 minutes reading time
by Christian Gausepohl (PhD) and Jürgen Ortlepp
LOGFILE Feature 25/2019 – Management of GMP Projects and New Factory Buildings
Management of GMP Projects and New Factory Buildings
A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018
8 minutes reading time
by Sabine Paris, PhD
LOGFILE Feature 23/2019 – GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)
GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)
The screenshots are excerpts from the Online Course GMP:READY – Specialist Knowledge GDP Compact
5 minutes reading time
LOGFILE Feature 22/2019 – Outsourcing: How to Assign a Contract Laboratory
Outsourcing: How to Assign a Contract Laboratory
An excerpt from the GMP Compliance Adviser, Chapter 17.B.4
5 minutes reading time
by Frank Boettcher, PhD