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GMP LOGFILE: Lead Article

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 2

30.04.2024

7 min. reading time | by Birte Scharf, PhD

Regulatory framework for ATMPs in the European Union

To address the specific requirements for manufacturing ATMPs, separate GMP regulations were published as Part IV of the EU GMP Guidelines in late 2017.

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 1

16.04.2024

7 min. reading time | by Birte Scharf, PhD

What are advanced therapy medicinal products (ATMPs)?

Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.

30 Years of GMP - A Personal View on Good Manufacturing Practices

09.04.2024

10 min. reading time | by Thomas Peither

When I worked on the first GMP projects as a consultant in 1994, the internet was still in its infancy. Getting an official copy of 21 CFR 210/211 was more than a hassle. You had to send a written request to the USA and after weeks, a barely legible copy would arrive by post.

Sources of Contamination: Rooms and Facilities

19.03.2024

6 min. reading time |  by Thomas Peither

Ensuring a clean production environment – sounds simple enough.However, in the pharmaceutical context, cleanliness and contamination are clearly defined, delineated and, of course, regulated, particularly in the manufacture of active ingredients and medicinal products.

Tests in the New Ph. Eur. Monograph on Cannabis Flower

05.03.2024

5 min. reading time | by Sabine Paris

The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024. All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph.

Can GMP Data be in the Cloud?

23.01.2024

7 min. reading time | by Thomas Peither

What is cloud computing?

Cloud computing is not a new technology, but a new way of providing resources for data processing.

How can the Life Cycle Approach be Applied to Cleaning Validation?

12.12.2023

5 min. reading time | by Thomas Peither

The life cycle approach to cleaning validation simply means that control of cleaning effectiveness must be maintained on an ongoing basis.

GMP Question of the Week: Top 15 in 2023

28.11.2023

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

14.11.2023

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?

31.10.2023

‘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

18.10.2023

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

04.10.2023

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

26.09.2023

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

12.09.2023

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

29.08.2023

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...

01.08.2023

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

25.07.2023

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

11.07.2023

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

04.07.2023

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

27.06.2023

8 min. reading time | by Thomas Peither

 

Standards and Data Types

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

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