GMP LOGFILE: Lead Article

Batch Designation: Handwritten or Electronic?

Ask our Experts

5 minutes reading time

by Doris Borchert

Acceptance testing or qualification?

Shortened excerpt from the GMP Compliance Adviser, "Chapter 3.J Qualification of premises and air handling technology"

7 minutes reading time

by Harald Flechl

The QP should decide or "lessons learned"

A GMP dialogue of the GMP conference, the GMP BERATER Tage, in October 2019 was entitled "The QP should decide or lessons learned". The participants brought along concrete questions, the experts gave clear answers. A lively exchange developed, during which the participants also reported in detail on their experiences. We have summarised the most important results for you in this protocol.

7 minutes reading time

GMP training courses in the online offline tension field

7 minutes reading time

by Sabine Paris, PhD

The power of the comma  Or: What do print data have to do with drug safety?

5 minutes reading time

by Doris Borchert, PhD

Questions about manufacturing technology

7 minutes reading time

by Doris Borchert, PhD

Trust is good, calibration is better!

Shortened excerpt from the GMP Compliance Adviser, Chapter 4.F Calibration

11 minutes reading time

by Hansjörg Gutmann, Markus Kopf, Markus Salemink, Dr. Christian Sander

The GMP Regulations Report 2019

At a glance and always at hand – the most relevant regulatory developments of 2019.

15 minutes reading time

by Sabine Rabus

7 Basic GMP Questions and Answers

A GMP dialogue of the GMP conference, the GMP BERATER Tage, in October 2019 was entitled "Basic GMP questions and answers". Here, the questions could be asked to which the participants always wanted to have an answer. The two experts provided answers in the course of a lively discussion.

Experts: GMP Inspector Petra Rempe, PhD, Josef Künzle, PhD, Head of Global Quality Management at Basilea

Protocol: Sabine Paris, PhD

MHRA: Feedback from GMP inspections

15 minutes reading time

by Tim Sandle

Packaging material testing

An excerpt from the new e-book GMP Series Packaging Materials for Pharmaceutical Products

5 minutes reading time
by André Deister, Sabine Mendel

TOP 15 Countdown: “Question of the Week”

Microbiological monitoring in non-sterile areas

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2019

7 minutes reading time

by Doris Borchert, PhD

Selection and procurement of cleanroom construction components

An excerpt from the new e-book A Pharma Guide to Planning and Constructing Cleanrooms

5 minutes reading time

by André Deister, Sabine Mendel

GDP inspections: How to avoid defects

Interview with Lea Joos, GMP inspector and author of the new GMP Compliance Adviser Chapter 16.S.2 "GDP inspections: frequent deficiencies in the qualification of logistics service providers and how to avoid them"

7 minutes reading time

by Lea Joos and Doris Borchert

Your question – our answer

Question about environmental monitoring

7 minutes reading time

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

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

PDA/FDA Joint Regulatory Conference 2019

6 minutes reading time

by Thomas Peither

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