GMP LOGFILE: Lead Article

12 min. reading time | by Thomas Peither

8 min. reading time | by Richard Denk

Isolator applications and design

Isolators are used in the handling of toxic and highly potent substances and in the production of sterile products.

9 min. reading time | by Stephanie Blum

In addition to the preceding general statements on the PQS, Chapter 1 of the EU GMP Guidelines contains specific information on GMP for medicinal products and quality control.

9 min. reading time | by Thomas Peither

The inspection is carried out in the front office and prepared in the back office. The preparation room is used to train and instruct staff.

11 min. reading time | by Thomas Peither

A definition of the term “qualification master plan (QMP)“ is not to be found in the GMP guidelines, only the term “validation master plan (VMP)”, which serves as a parent document.

9 min. reading time | by Dennis Sandkühler

On the basis of the process-related requirements set out in the specifications, ISPE GAMP® 5 provides for a process risk analysis to identify risks relating to patient safety, product quality, data integrity and compliance requirements.

9 min. reading time | by Lea Joos

The deficiency

During a tour of the production area, it was discovered at several points that the rooms were not sufficiently maintained:

7 min. reading time | by Stephanie Blum

With this e-learning course you can get familiar with the topic of Good Distribution Practice (GDP)!

10 min. reading time | by Christian Gausepohl

When selecting balances, technical aspects such as resolution, precision and weighing range must be taken into account, as must special design features.

7 min. reading time | by Harald Flechl

The design qualification process may vary depending on the project and the client's requirements and may be carried out in two or three design phases.

10 min. reading time | by Chistian Gausepohl

The transfer of a product to a contract manufacturer can be divided into different phases.

15 min. reading time | by Ulrich Kissel and David Cockburn

Social distancing posed an interesting question for the Qualified Person (QP) in the early days of the COVID-19 pandemic:

7 min. reading time | by Christian Gausepohl

Most companies have established different categories (qualification status) for the suppliers of starting materials and packaging materials they use.

8 min. reading time | by Thomas Peither

Were you able to follow the PDA Annual Meeting of the Parenteral Drug Association this year? Or were you like many others who spent the whole day with web meetings and have no time or mood for more online conferences?

4 min. reading time | by Michael Hiob and Sabine Paris,PhD

A referral is a procedure used to resolve concerns over the safety, efficacy or quality of a medicinal product (or a class of medicines). In a referral, the EMA is requested to conduct a scientific assessment of the products in question on behalf of the European Union (EU).

The time has come, the curtain goes up! Now your brand-new online journal is launched.
Let the newly designed GMP:Blog support you in the work with GMP.

5 min. reading time | by Roland Kleissendorf

A correctly formulated packaging material specification provides a comprehensive description of the packaging material and serves as a guideline for the respective packaging materials supplier.

8 min. reading time | by Sabine Paris

In 2015, with the revision of Chapters 3 and 5 and Annex 15 of the EU GMP Guide and with the publication of the EMA PDE Guideline a paradigm shift took place in establishing limit values for the validation of cleaning processes.

18 min. reading time

Today’s feature focuses on GMP risk analysis. It is an excerpt from the E-Learning GMP:READY – GMP for Engineers. GMP:READY provides knowledge for the planning, qualification and maintenance of the pharmaceutical equipment and facilities.

5 min. reading time | by Markus Veit

Introduction

This chapter deals with the practical aspects of implementing the European requirements for data integrity.