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GMP LOGFILE: Lead Article
LOGFILE No. 05/2019 – GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment
05.02.2019
GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment
Excerpt from the GMP Series Download GMP Supplier Assessment Questionnaire
4 minutes reading time
by Cornelia Wawretschek
LOGFILE No. 04/2019 – DT When and how must OOS examinations be triggered?
29.01.2019
When and how must OOS examinations be triggered?
Your question - Our answer
6 minutes reading time
by Doris Borchert, PhD
LOGFILE No. 03/2019 – Microbiological Monitoring: Actions when levels are exceeded
22.01.2019
Microbiological Monitoring: Actions when levels are exceeded
Excerpt from the GMP Compliance Adviser, Chapter 10.E
5 minutes reading time
by Hanfried Seyfarth, PhD
LOGFILE No. 02/2019 – Who may carry out the sampling?
08.01.2019
Who may carry out the sampling?
Ask our experts
5 minutes reading time
by Doris Borchert, PhD
LOGFILE No. 01/2019 – Agency Expectations: Design Qualification
04.12.2018
Qualification and Validation: Agency Expectations – Design Qualification (DQ)
Excerpt from the GMP Series Download Qualification and Validation: Agency Expectations
5 minutes reading time
by Michael Hiob, PhD
LOGFILE No. 46/2018 – Product Transfer Challenges
27.11.2018
Product Transfer Challenges
An excerpt from the GMP Series Download A Successful Concept for Technology Transfer in Drug Manufacturing
4 minutes reading time
by Christian Gausepohl, PhD
LOGFILE No. 45/2018 – GDP Questionnaire – Incoming goods
13.11.2018
GDP Questionnaire – Incoming goods
An excerpt from the GDP Questionnaire
5 minutes reading time
by Simone Ferrante
LOGFILE No. 44/2018 – What is quality management?
06.11.2018
What is quality management?
An excerpt from the GMP Fundamentals
5 minutes reading time
by Christine Oechslein, PhD
LOGFILE No. 42/2018 – The Structure of Electronic Document Management and Quality Management Systems (EDMS/EQMS)
30.10.2018
The Structure of Electronic Document Management and Quality Management Systems (EDMS/EQMS)
An excerpt from the GMP Compliance Adviser, Chapter 1.H.2
5 minutes reading time
by Thilo Gukelberger
LOGFILE No. 43/2018 – Paradigm shift in the establishment of limits for the validation of cleaning processes
30.10.2018
Paradigm shift in the establishment of limits for the validation of cleaning processes
An excerpt from the GMP Series Download A Pharma Guide to Cleaning Validation
5 minutes reading time
by Jens Hrach, PhD
LOGFILE No. 41/2018 – Inspection of Process Validation
23.10.2018
Inspection of Process Validation
An excerpt from the new GMP Series Download Inspection of Process Validation
6 minutes reading time
LOGFILE No. 40/2018 – Ventilation units, or the invisible energy in the clean room
16.10.2018
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 No. 39/2018 – Batch release process steps
09.10.2018
Batch release process steps
An excerpt from the new GMP Series PDF Download EU-Compliant Batch Release of Medicinal Products
6 minutes reading time
by Rainer Gnibl, PhD
LOGFILE No. 38/2018 – Blockchain: Will it Transform the Pharmaceutical Supply Chain?
09.10.2018
Blockchain: Will it Transform the Pharmaceutical Supply Chain?
6 minutes reading time
by Mark Crawford
LOGFILE No. 37/2018 – What is the point of "heating" medicinal products to 15–25 °C?
25.09.2018
What is the point of "heating" medicinal products to 15–25 °C?
A case study challenging conventional limits
An excerpt from the GMP Compliance Adviser, Chapter 24.F
6 minutes reading time
by Christoph Frick, PhD
LOGFILE No. 36/2018 – Calibration of Laboratory Instruments
20.09.2018
Calibration of Laboratory Instruments
An excerpt from the new GMP Series PDF Download Qualification and Calibration of Laboratory Instruments in Pharmaproduction
5 minutes reading time
by Josef Künzle, PhD
LOGFILE No. 35/2018 – Quality Oversight and Lean QA
13.09.2018
Quality Oversight and Lean QA
A Summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017
6 minutes reading time
by Susanne Saile
LOGFILE No. 34/2018 – Failure Management in a GMP Regulated Environment
04.09.2018
Failure Management in a GMP Regulated Environment
An excerpt from the new GMP Series PDF Download Failure Management in a GMP Regulated Environment
5 minutes reading time
by Martin Mayer
LOGFILE No. 33/2018 – Regulatory Update at the PDA European Annual Meeting
29.08.2018
Regulatory Update at the PDA European Annual Meeting
A report on the PDA European Annual Meeting 2018 – Part 2
6 minutes reading time
by Thomas Peither
LOGFILE No. 32/2018 – Risk Analysis of a Pharmaceutical Water System
22.08.2018
Risk Analysis of a Pharmaceutical Water System
An excerpt from the GMP Series PDF Download Qualification of Pharma Water Supply Systems
5 minutes reading time
by Fritz Röder