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GMP LOGFILE: Lead Article

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 min. reading time | by Sabine Rabus


EMA: Update of Q&A on EU/US MRA, December 2019

7 Basic GMP Questions and Answers


7 min. reading time | by Dr. Sabine Paris


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 min. 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].

Packaging material testing


5 min. 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.

TOP 15 Countdown: “Question of the Week”


10 min. reading time


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

Microbiological monitoring in non-sterile areas


7 min. reading time | ​by Doris Borchert


At our GMP Conference, the “GMP-BERATER Tage“, in October 2019 we presented a GMP dialogue on "Microbiological Monitoring in non-sterile areas". Questions on the topic were asked by participants and answered by GMP inspector Franz Schönfeld, PhD and microbiologist Frank Mertens, PhD in a lively discussion.

Selection and procurement of cleanroom construction components


5 min. reading time | ​by André Deister, Sabine Mendel


Selection and procurement

GDP inspections: How to avoid defects


7 min. reading time | by Lea Joos and Doris Borchert


Mrs. Joos, you put in your new chapter "GDP inspections: Frequent deficiencies and how to avoid them" the 10 most common deficiencies in the qualification of logistics service providers. In your opinion, where are the biggest deficits?

Your question – our answer: Environmental Monitoring


7 min. reading time


"We have an active pharmaceutical ingredient (ICH Q7) in our GMP warehouse which may be stored up to max. 40°C according to the stability data available. This is the suspension of a UV filter. Now the existing monitoring system is to be replaced.

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