GMP LOGFILE: Lead Article

5 min. reading time | by GMP-Verlag Peither AG

Every week we publish interesting questions and answers about GMP in our column GMP Question of the Week. Today we have compiled the most clicked questions of this year (as of November 2023).

Browse the Top 15 and refresh your knowledge!

Detailed information on each topic can be found in the GMP Compliance Adviser, the world's largest reference work on quality management in the pharmaceutical industry.

7 min. reading time | by Thomas Peither

The stability of a medicinal product or an active substance is defined as the maintenance of certain quality characteristics (specification) over a fixed period of time under defined conditions.

‘Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.‘ This is explicitly stated in the EU GMP Directive 2017/1572.

5 min. reading time | by Thomas Peither

When we take a drug, we first and foremost want it to work – to cure an illness or at least alleviate its symptoms.

7 min. reading time | by Thomas Peither

Subjectivity in QRM should be addressed in every organisation. I had the opportunity to attend a very stimulating presentation by Alex Viehmann, Division Director at OPQ, CDER, U.S. FDA, who shared insights into the new ICH Q9 Guideline on Quality Risk Management (QRM) at the PDA/FDA Joint Regulatory Conference 2023, 18-20 September in Washington.

13 min. reading time | by Christian Gausepohl, PhD

To err is human - and is only too willingly used as the most probable cause for deviations of all kinds. It is also temptingly easy to look for the cause of error in individual (mis)behaviour. Everyone has a bad day, is distracted or unfocused, forgets or mixes things up and makes mistakes, even though they "actually" know how to do it correctly.

The monitoring of critical parameters is largely automated and is part of the plant control system. In the event of a critical system alarm (e.g. TOC outside of tolerance limits), the control system also performs the system shutdown or the transition to a safe operation mode.

4 min. reading time | by Harald Flechl

According to the new Annex 1, a Contamination Control Strategy (CCS) must be implemented for the entire cleanroom and controlled environment system of the facility.

3 min. reading time | GMP-Verlag

Gastrointestinal medicines, headache tablets and perhaps a gel to soothe insect bites? It's no big hassle to pack these and yet they give you a reassuring feeling of security.

10 min. reading time | by Cornelia Wawretschek and Jens Hrach, PhD

Cleaning Validation

One of the basic principles of a cleaning validation is the setting of limits for possible cross-contaminants in the subsequent product.

8 min. reading time | by Thomas Peither

General requirements

Adequate size and lighting of all areas where medicinal products, starting materials and packaging materials are stored is essential for the proper performance of operations.

5 min. reading time | by Dennis Sandkühler, PhD

Fundamentally, the use of computerised systems in GxP environments requires a consideration of regulatory requirements.

8 min. reading time | by Thomas Peither

Standards and Data Types

The following standards can be used as a basis for cleanroom monitoring plans:

5 min. reading time | by Christoph Brewi and Florian Sieder, PhD

What is meant by CCS?

The current Annex 1 (version of 22/08/2022) of the EU GMP Guide marks a paradigm shift in the rules and regulations of Good Manufacturing Practice (GMP).

5 min. reading time | by Stephanie Blum

Reference standards

Pharmacopoeial standards are obtained by the chemicals officer from the issuing body and do not require further characterisation before use.

5 min. reading time | by Sabine Paris

The Swiss Biotech Day 2023 took place on 24 and 25 April in Basel. The conference is one of the industry's most important meeting places for developers and manufacturers of biopharmaceuticals and is growing in popularity every year.

10 min. reading time | by Petra Berlemann

A software quality plan – what is it and how do you create such a document?

7 min. reading time | by Thomas Peither

You know the sustainability goals in your company, such as achieving CO₂ neutrality by 2030 or 2050. But what does that have to do with GMP?

9 min. reading time | by Harald Flechl

7 min. reading time | by Simone Ferrante

Assessment of GxP relevance

Every upcoming change must be checked for GxP-relevance by the responsible person for GDP.