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GMP LOGFILE: Lead Article

Remote, Distance, Offsite or Virtual Audits?


12 min. reading time | by Thomas Peither

Planning, Construction and Commissioning of an Isolator


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.

Practical implementation of the PQS


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.

GMP Inspections: Organisation of the Front and Back Office


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.

Qualification Master Plan: Regulatory Requirements


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.

Alternative Approach to Risk Assessment of Computerised Systems


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.

Frequent Deficiencies in GMP Inspections – Here: Insufficient Maintenance of Rooms


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:

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)


7 min. reading time | by Stephanie Blum


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

Requirements for Balances Used in Pharmaceutical Production


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.

Design Qualification for Premises and Air Handling Units


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.

Contract Manufacturing: Technology Transfer Phases


10 min. reading time | by Chistian Gausepohl


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

Survey of qualified persons on remote certification


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:

Importance of Supplier Qualification Status


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.

Innovations in Pharmaceutical Manufacturing


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?

European Safety Referral: Short and Crisp


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 GMP:Blog is online!


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.

Specifications for packaging materials


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.

Agency Expectations on PDE Reports


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.

GMP Risk Analysis in Qualification


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.

Data Integrity in the Quality Control Laboratory


5 min. reading time | by Markus Veit



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

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