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GMP LOGFILE: Lead Article

GMP:READY: GMP for Engineers


5 minutes reading time

FMD alerts in 2020 – where we are a year into legislation


9 minutes reading time | by Grant Courtney

Purpose and content of a management review


5 minutes reading time | by Stephanie Blum

Challenges lurking in manufacturing


A GMP-DIALOGUE of our GMP conference, the GMP-BERATER-Days, in October 2019 revolved around the topic "Challenges lurking in manufacturing". Questions on the topic were asked by participants and answered by the experts in a lively discussion.



7 minutes reading time | by Brian Matye, Jeanne Moldenhauer, Susan Schniepp


Nothing ventured, nothing gained


by Petra Rempe (PhD) and Martin Mayer

An excerpt from the GMP Compliance Adviser, Chapters 19.A Agency expectations of quality risk management and 19.B Application and benefits of QRM in the pharmaceutical industry

Disruptive technologies in the production of pharmaceuticals


8 minutes reading time 


A GMP-DIALOGUE of the GMP Conference, the GMP-BERATER Tage, in October 2019 revolved around the topic "Disruptive technologies in the production of pharmaceuticals". The participants asked questions about the topic, which the two experts answered in an exciting discussion.

Batch Designation: Handwritten or Electronic?


5 minutes reading time | by Doris Borchert


In our company, every step of the production process is documented on the batch processing record, which is printed out on paper beforehand. Prior to this, all batches used were entered in the record by hand. This often resulted in an unclear spelling.

Acceptance testing or qualification?


7 minutes reading time | by Harald Flechl


Buildings for pharmaceutical production and the therein integrated infrastructure systems have in common that they have to be planned, realised and operated individually and according to the specific case. This individual character results in an increased risk of faults, which must be recognised and rectified in a timely manner so that they do not endanger the quality of the produced medicinal products.

The QP should decide or "lessons learned"


7 minutes reading time


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.

GMP training courses in the online offline tension field


7 minutes reading time | by Sabine Paris, PhD


Are you already training online or still offline? What do the employees, the management, the works council and other stakeholders want? How can this be controlled and GMP-compliant? How can blended learning be implemented?

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


5 minutes reading time | by Doris Borchert, PhD


Would you have known? Around 90% of all product recalls by pharmaceutical companies are due to errors in printed packaging materials. It is not the quality of the drug per se that calls patient safety into question, but incorrect or faulty information on the packaging.

Questions about manufacturing technology


7 minutes reading time | by Doris Borchert, PhD


At our GMP conference, the GMP-BERATER Tage in October 2019 the GMP-DIALOGUE on the topic "Technology for the manufacture of medicinal products" took place. Questions on the topic were asked by participants and answered by GMP inspector Rainer Gnibl, PhD and technology-expert Ruven Brandes in a lively discussion.

Trust is good, calibration is better!


11 minutes reading time | by Hansjörg Gutmann, Markus Kopf, Markus Salemink, Dr. Christian Sander


Numbers play a key role in the manufacture of medicinal products. From the receipt of the raw materials to the final release of the finished product, results (actual values) are repeatedly compared with specifications (target values) to decide whether the quality meets the requirements. This applies equally to measured values in the manufacturing process and to analytical results in the laboratory.

The GMP Regulations Report 2019


15 minutes reading time | by Sabine Rabus

7 Basic GMP Questions and Answers


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

Protocol: Sabine Paris, PhD

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.


MHRA: Feedback from GMP inspections


15 minutes reading time | by Tim Sandle


To assist pharmaceutical manufacturers and distributors to understand the areas where good manufacturing practice (GMP) inspectors have found compliance problems during GMP inspections in the UK and overseas, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) GMP  Inspectorate has issued data, during October 2019, relating to common deficiencies from previous GMP inspections conducted during 2018 [1]. While the anonymised raw data provided by the GMP Inspectorate is of general interest, additional analysis is required to draw meaningful inferences. In this article, the data has been reviewed and presented, in order to obtain an overview of key trends.

Packaging material testing


5 minutes reading time | by André Deister, Sabine Mendel


Pharmaceutical packaging materials have a variety of functions. The main purpose of primary packaging materials, for example, is to protect the medicinal product against the physical effects of light, air and moisture. Secondary packaging materials provide information on the amount, dosage type and application of the packaged medicinal product. However, secondary packaging, in particular, is increasingly being used to fulfil other functions such as the prevention of counterfeiting. It is also used for marketing purposes, to ensure child safety and for braille text. The wide range of packaging material functions is reflected in the complex testing of packaging material components.

TOP 15 Countdown: “Question of the Week”


As a LOGFILE subscriber you are already familiar with our "Question of the week". 

Every week we publish GMP related questions which you might have asked yourself before. Get short and precise answers, links and working material to the corresponding chapters in the GMP Compliance Adviser.

Do you have any questions?

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