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GMP LOGFILE: Lead Article

Microbiological monitoring in non-sterile areas

28.01.2020

7 minutes reading time | ​by Doris Borchert, PhD

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

22.01.2020

5 minutes reading time | ​by André Deister, Sabine Mendel

GDP inspections: How to avoid defects

14.01.2020

7 minutes 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

07.01.2020

7 minutes 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.

Failure Management in a GMP Regulated Environment

10.12.2019

5 minutes reading time | by Martin Mayer

 

An excerpt from the GMP Series e-book Failure Management in a GMP Regulated Environment

Ventilation units, or the invisible energy in the clean room

03.12.2019

9 minutes reading time | by Doris Borchert, PhD

 

Ventilation units are the heart of cleanrooms. They enable the air to circulate in the same way as the heart enables the blood to do so in the human body.

PDA/FDA Joint Regulatory Conference 2019

26.11.2019

6 minutes reading time | by Thomas Peither

 

The PDA/FDA Joint Regulatory Conference in September in Washington, DC, was once again an important meeting place for the pharmaceutical industry this year. Topics ranged from regulatory updates, quality aspects, compliance challenges, new technologies for manufacturing, laboratory and quality assurance to control strategies, facility life cycles, inspection strategies and audit effectiveness. The conference covered a broad range of various quality aspects relevant to the pharmaceutical manufacturers.

Transfer of analytical procedures to the contract laboratory

19.11.2019

4 minutes reading time | by Frank Böttcher, PhD

 

An excerpt from the e-book Managing Contract Manufacturers and Testing Labs and the online knowledge portal GMP Compliance Adviser

In 8 steps to self-learning FMEA

12.11.2019

6 minutes reading time | by Felix Tobias Kern, PhD

 

The legislation's demand on the pharmaceutical industry for an integrated risk approach (e.g. according to ICH Q9) implies major challenges in terms of effort and costs.

New Toxicological Assessment Services of GMP Publishing

05.11.2019

10 minutes reading time | by Sabine Paris, PhD

Batch release process steps

29.10.2019

6 minutes reading time | by Rainer Gnibl, PhD

 

An excerpt from the e-book EU-Compliant Batch Release of Medicinal Products

Sliding doors in clean rooms – "no go" or "best practice"?

22.10.2019

7 minutes reading time | by Harald Flechl / Dr Doris Borchert (editorial editing)

 

A shortened and edited excerpt from the GMP Compliance Adviser, Chapter 3.E

Is there a legal requirement for the document language of GMP-relevant documents?

15.10.2019

4 minutes reading time | by Sabine Rabus

 

In our company it is planned to write all documents in English. However, many employees do not speak English. Is there a rule that says that the documents must be "readable and understandable" for employees?

EDQM inspections and trends of deficiencies relating to API facilities

08.10.2019

10 minutes reading time | by Tim Sandle

 

In recent years, there has been an increase in international drug inspections to assure that good manufacturing practice (GMP) is being appropriately applied no matter where a bulk pharmaceutical chemical or active pharmaceutical ingredient (API) is made. With the regulation and inspection of API manufacturers falling under agencies operating in the European Economic Area, there has been little (until now) trend data relating to facility inspections.

Data integrity in the quality control laboratory

01.10.2019

5 minutes reading time | by Markus Veit, PhD

 

An excerpt from the GMP Compliance Adviser, Chapter 14.L.1 and the GMP Focus e-book Data Integrity in the EU

Your E-Learning Trial Version

24.09.2019

An excerpt from the GMP:READY – GMP for Engineers

2 minutes reading time

Passive transport packaging

17.09.2019

5 minutes reading time | by Christoph Frick, PhD, and Nicola Spiggelkötter, PhD

 

An excerpt from the GMP Compliance Adviser, Chapter 24.J.3

Administration and control of substances

10.09.2019

3 minutes reading time | by Markus Limberger, PhD

 

An excerpt from the new e-book Core Processes in the Pharmaceutical Laboratory

GDP - DIN SPEC 91323: Uniform testing standards for vehicles used for the transport of pharmaceuticals

03.09.2019

12 minutes reading time | by Sabine Rabus

 

The transport of pharmaceuticals is subject to strict requirements. This reality has long since arrived in logistics. Transparency, reliability and compliance with rules are therefore part of the daily business of a pharmaceutical logistics company.

Zone concept and clean room classes

27.08.2019

An excerpt from the step-by-step guide GMP Fundamentals

6 minutes reading time | by Christine Oechslein, PhD

 

If somebody kept their shoes in a china cupboard or prepared a cream cake in the bathroom (directly beside the hairbrush and razor), most people would find it unhygienic. We are used to our living room and other rooms being used for particular activities.

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