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GMP LOGFILE: Lead Article

Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?


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.

Basis of Cleaning Validation: Setting of PDE Limits


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

Process Development as the Basis for Process Validation


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.

Test interval for integrity testing of HEPA filters in a laminar flow above an injection moulding machine


12 min. reading time | by Harald Flechl



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.

IT Service Providers: Service Level Agreement


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.


Stability Studies During the Authorisation Phase of Medicinal Products


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.

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?

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