GMP LOGFILE: Lead Article

10 minutes reading time | by Thomas Peither

8 minutes reading time | by Christine Oechslein, PhD

In Part I, Paragraph 2.11 of the EU GMP Guidelines, it is required that "approved training programmes should be available" in GMP-liable establishments.

10 minutes reading time | by Thomas Peither

What an exceptional conference! From June 25th-26th, 2019, the PDA Europe Annual Meeting in Amsterdam was again a meeting that demonstrated the current view on important topics in the pharmaceutical business. The first part of the conference summary covers the plenary session in the morning of the first conference day.

An excerpt from the GMP Compliance Adviser, Chapter 14.K.2

4 minutes reading time | by Markus Veit, PhD

Pharmacopoeias play an important role in quality control. They define important standards and framework conditions for tests; they contain requirements for reagents and reference materials as well as specifications for active substances (APIs), excipients, packaging materials and medicinal products. In addition, pharmacopoeias also contain descriptions of all relevant test methods.

An excerpt from the new e-book Storage of Medicinal Products

4 minutes reading time | by Christian Gausepohl (PhD) and Jürgen Ortlepp

8 minutes reading time | by Sabine Paris, PhD

At the GMP BERATER Days in October 2018, the GMP Dialogue on "Management of GMP Projects and New Factory Buildings" took place. Questions about the topic were asked by the participants and answered by the experts Dr Helmut Bender, Boehringer Ingelheim, and GMP inspector Dr Daniel Müller and in a lively discussion.

The screenshots are excerpts from the Online Course GMP:READY – Specialist Knowledge GDP Compact

5 minutes reading time

With this e-learning course you can get familiar with the topic of Good Distribution Practice (GDP)! The aim is to explain the GDP-Regulation principles in a quick and sufficient way.

An excerpt from the GMP Compliance Adviser, Chapter 17.B.4

5 minutes reading time | by Frank Boettcher, PhD

Apart from the statutory requirements that must be observed, commercial aspects and corporate policy also have a role to play when selecting a contract laboratory.

An excerpt from the new e-book The Road to a Pharmaceutical Quality System

4 minutes reading time | by Stephanie Blum, PhD

6 minutes reading time | by Sabine Paris, PhD

The European Annual Conference of the International Society of Pharmaceutical Engineering (ISPE) attracted over 700 participants to Dublin from 1st to 3rd April 2019. The main topic was “Drive and Leverage Innovation for Pharma”.

5 minutes reading time | by Sabine Paris, PhD

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?

6 minutes reading time | by Doris Borchert, PhD

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 itself that calls into question patient safety, but incorrect or erroneous information on the packaging. A comma on our bank statements can bring tears to our eyes or a smile on our lips. The incorrect positioning of a comma in the indication of a dosage quantity, however, represents a serious patient risk. The figure 4.0mg on the paper "only" differs by a comma of 40mg - de facto, however, there is a factor of 10 behind it, which under certain circumstances can decide between life and death.

7 minutes reading time | by Sabine Paris, PhD

The European Annual Conference of the International Society of Pharmaceutical Engineering (ISPE) attracted over 700 participants to Dublin from 1st to 3rd April 2019. The main topic was “Drive and Leverage Innovation for Pharma”. The Executive Forum focused on the industrial digitisation as a key enabler to drive innovation. Driving continuous improvement in a digital age needs a number of pre-requisites and face new challenges and opportunities.

9 minutes reading time | by Paulino Alonso

The ICH Q3D Guideline for Elemental Impurities came into effect on January 2018 for all the products for human use. To date, most of the companies have finished the implementation (maybe not at 100%, but ongoing) and now, the challenge is to keep the reports updated.

An excerpt from the GMP Focus PDF Download Principles of Equipment Qualification

5 minutes reading time | by Ulrike Reuter

Introduction

Despite much discussion about the subject over the past three years in particular, data integrity issues remain a common feature on 483 letters issued by the U.S. Food and Drug Administration and data handling matters are also a focus of enforcement actions (as well as inspection findings from other regulatory agencies). It is perhaps for this reason that the FDA has issued a new guidance document titled “Data Integrity and Compliance with Drug cGMP: Questions and Answers” (1). According to the FDA, the reason for issuing the new document is: “to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.” The document joins others from MHRA (2, 3), OCED (4), WHO (5), and PIC/S (6, 7) on the general subject.

An excerpt from the new GMP Series Download Qualification and Calibration of Laboratory Instruments in Pharmaproduction

5 minutes reading time | by Josef Künzle, PhD

8 minutes reading time | by Doris Borchert, PhD

There are no regulatory requirements for the definition of air quality and its monitoring in non-sterile production areas. The topic was discussed by our team of experts and in some cases very different answers were received. The different points of view made us curious - how is this question solved in pharmaceutical practice?

An excerpt from the GMP Series PDF Download Qualification of Pharma Water Supply Systems

5 minutes reading time | by Fritz Röder

As in the case of all qualifications, the risk analysis is carried out to consolidate the knowledge of all the parties involved and define the necessary test and action points required for the qualification. This is an extremely time-consuming process.

4 minutes reading time | by Christine Oechslein, PhD

E-learning can be seen as didactically meaningful support in the learning process. More and more people prefer to use their PCs and the internet instead of attending seminars or reading documents. The younger generation in particular, who grew up with computers, can absorb a lot of learning content better and faster through e-learning, or can already work out familiar contents in addition.