GMP LOGFILE: Lead Article

7 min. reading time | by Felix Tobias Kern, PhD, and Fritz Röder

Defect evaluation lists and defect pattern libraries are popular GMP documents that have been used for more than 45 years. They serve as a rationale for the quality assessment of individual batches and set quality standards for the manufacture and testing of pharmaceutical products.

11 min. reading time | by Cornelia Wawretschek, Jens Hrach, PhD

7 min. reading time |

A GMP compliant and successful process validation is only possible when a 'robust' ¹ pharmaceutical development of the medicinal product has been performed, regardless of which development methods are applied.

12 min. reading time | by Harald Flechl

Question:

We operate a laminar flow above an injection moulding machine in a cleanroom, GMP Grade C (ISO 8 in operation, ISO 7/at rest). The laminar flow achieves ISO class 5 within the cleanroom area.

8 min. reading time | by Markus Roemer, Siegfried Schmitt, PhD

The written contract on the outsourced activities can take the form of an internal service agreement or an external service agreement. In both cases, it is used to describe.

7 min. reading time | by Heike Meichsner, Olaf Mundszinger, PhD, Susanne Schweizer

The registration batches correspond as nearly as possible to the later commercial batches in the marketing phase with regard to the equipment, starting materials and manufacturing processes used.

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?