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GMP LOGFILE: Lead Article

FMD alerts in 2020 – where we are a year into legislation

09.06.2020

9 min. reading time | by Grant Courtney

Environmental Risk Assessment: ERA Reports

02.06.2020

8 min. reading time

 

1 Introduction: environmental risk evaluation

Purpose and content of a management review

26.05.2020

5 min. reading time | by Stephanie Blum

 

A management review is carried out on a regular basis to check the suitability and effectiveness of the pharmaceutical quality system (PQS). It is one of the most effective PQS tools available.

Challenges lurking in manufacturing

19.05.2020

8 min. reading time | by Dr. Sabine Paris

 

Experts:            GMP inspector Lea Joos, Christian Gausepohl, PhD, QP and Head of Quality Unit

12 FREQUENTLY ASKED QUESTIONS on SOPs

12.05.2020

7 min. reading time | by Brian Matye, Jeanne Moldenhauer, Susan Schniepp

 

Question: How often should I review my SOPs?

Disruptive technologies in the production of pharmaceuticals

28.04.2020

8 min. reading time | by Nadja Schaubhut

 

A GMP-DIALOGUE of the GMP Conference, the GMP-BERATER Tage, in October 2019 revolved around the topic "Disruptive technologies in the production of pharmaceuticals". The participants asked questions about the topic, which the two experts answered in an exciting discussion.

Batch Designation: Handwritten or Electronic?

21.04.2020

5 min. reading time | by Doris Borchert

 

In our company, every step of the production process is documented on the batch processing record, which is printed out on paper beforehand. Prior to this, all batches used were entered in the record by hand. This often resulted in an unclear spelling.

Acceptance testing or qualification?

15.04.2020

7 min. reading time | by Harald Flechl

 

Buildings for pharmaceutical production and the therein integrated infrastructure systems have in common that they have to be planned, realised and operated individually and according to the specific case. This individual character results in an increased risk of faults, which must be recognised and rectified in a timely manner so that they do not endanger the quality of the produced medicinal products.

The QP should decide or "lessons learned"

08.04.2020

7 min. reading time | by Sabine Rabus

 

A GMP dialogue of the GMP conference, the GMP BERATER Tage, in October 2019 was entitled "The QP should decide or lessons learned". The participants brought along concrete questions, the experts gave clear answers. A lively exchange developed, during which the participants also reported in detail on their experiences. We have summarised the most important results for you in this protocol.

GMP training courses in the online offline tension field

01.04.2020

7 min. reading time | by Sabine Paris

 

Are you already training online or still offline? What do the employees, the management, the works council and other stakeholders want? How can this be controlled and GMP-compliant? How can blended learning be implemented?

The power of the comma Or: What do print data have to do with drug safety?

24.03.2020

5 min. reading time | by Doris Borchert

 

Would you have known? Around 90% of all product recalls by pharmaceutical companies are due to errors in printed packaging materials. It is not the quality of the drug per se that calls patient safety into question, but incorrect or faulty information on the packaging.

Questions about manufacturing technology

18.03.2020

7 min. reading time | by Doris Borchert

 

At our GMP conference, the GMP-BERATER Tage in October 2019 the GMP-DIALOGUE on the topic "Technology for the manufacture of medicinal products" took place. Questions on the topic were asked by participants and answered by GMP inspector Rainer Gnibl, PhD and technology-expert Ruven Brandes in a lively discussion.

Trust is good, calibration is better!

10.03.2020

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

04.03.2020

15 min. reading time | by Sabine Rabus

 

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

7 Basic GMP Questions and Answers

26.02.2020

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

18.02.2020

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

11.02.2020

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”

04.02.2020

10 min. reading time

 

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

Microbiological monitoring in non-sterile areas

28.01.2020

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.

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