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GMP LOGFILE: Lead Article

GMP Question of the Week: Top 15 in 2023


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.

Nothing lasts Forever: Stability Tests are Indispensable


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.

Personnel Hygiene is not a Delicate Matter! – What are Hygiene Programmes for?


‘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.

Organisation of Quality Assurance


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.

The New ICH Q9 Guideline: The Next Generation of Quality Management


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.

Insight at Second Glance - The Human Error and its Root Causes


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.

Monitoring of Parameters and Water Quality


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.

Contamination Control – Cleanliness Zone Concepts


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.

When travelling...


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.

Basis of Cleaning Validation: Setting of PDE Limits


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.

GMP/GDP Requirements for Different Storage Areas


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.

Regulatory Requirements for Computerised Systems


5 min. reading time | by Dennis Sandkühler, PhD


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

Air Handling Systems: GMP Compliant Monitoring and Energy-Saving Operation


8 min. reading time | by Thomas Peither


Standards and Data Types

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

New in Annex 1: the Contamination Control Strategy (CCS)


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).

Reference Standards in the Pharmaceutical Laboratory: Procurement and Characterisation


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.

Biotechnological Medicinal Products: Global Trends and Perspectives


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.

GMP Compliant Plant Qualification: Software Quality Plan


10 min. reading time | by Petra Berlemann


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

greenGMP Supports the Sustainability Goals in the Company


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?

Change Control at the Wholesaler or Logistics Provider: Assessment of GxP Relevance


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.

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