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GMP LOGFILE: Lead Article

GMP is not ISO 9001 – Where are the Similarities and Differences?


7 min. reading time | by Thomas Peither


Standards such as those in the DIN EN ISO series are not laws, so ISO standards differ quite fundamentally from legally binding regulations. Good Manufacturing Practice (GMP), on the other hand, is laid down in laws, regulations and guidelines.

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.

Basis of Cleaning Validation: Setting of PDE Limits


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


Cleaning Validation

4 Questions on the Import of Medicinal Products and APIs


6 min. reading time | by Simone Ferrante


GMP or GDP – Which applies for importation?

Although the import of medicinal products is an act related to dis-tribution and logistics, this activity is considered GMP relevant in the EU and is therefore subject to GMP requirements.

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems


8 min. reading time | by Richard Denk

The first draft of version 9 of Annex 1 of the EU GMP Guide on 20 December 2017 attracted a lot of interest globally – firstly because it was the first publication on the topic in almost a decade, and secondly because PIC/S and WHO co-authored the document.

Why is it Necessary to “Manage“ Quality?


6 min. reading time | by Christine Oechslein, PhD

The quality of a medicinal product cannot be left to chance, but must be the result of carefully planned actions. The sequence "planning, acting, evaluating, improving" is referred to as "management".

Reaching the next GMP Level with Inspection Readiness Projects


9 min. reading time | by Frank Studt and Thomas Peither

Definition of Hygiene Zones


7 min. reading time | by Christine Oechslein, PhD

How is process validation differentiated from other elements of quality management?


8 min. reading time | by Thomas Peither


The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.

Import of Medicinal Products – Clarifications in Annex 21


10 min. reading time | by Sabine Paris, PhD


The new Annex 21: Importation of medicinal products to the EU GMP Guide has been published on February 21, 2022 and will enter into force on August 21, 2022. The 6-page annex summarises the GMP requirements for Manufacturer/Importer Authorisation (MIA) holders to import medicinal products (human, investigational and veterinary) from outside the EU/EEA (we reported).

Initial Classification of a Commercial Return (CR) by the CR Coordinator


7 min. reading time | by Alexandra Fürst


CAPA Systems: Autonomous or Integrated?


8 min. reading time | by Thomas Peither


A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.

Risk Analysis in the Equipment Life Cycle


5 min. reading time |


From the start of the project to the release of the technical design: Risk analysis is a constant companion.
Risk analyses can or must be carried out at different points in time within the process of procurement and qualification. Here is a brief outline of the phases of risk analyses in project implementation.

13 GMP Requirements for Excipient Manufacturers


7 min. reading time | by Stephanie Blum, PhD


Based on the risk assessment documented in the excipient dossier and the risk profile of the excipient, the risk team defines the necessary GMP requirements in the next step.

Deviation Causes as KPIs – Collection vs. Assessment


7 min. reading time | by Felix Kern, PhD and Liwa Schneider


Deviation management plays an increasingly important role in the collection and review of KPIs (Key Performance Indicators) for pharmaceutical production and quality processes. Tracking the cause of deviations in particular provides information on how stable the respective processes are, where there are gaps and where countermeasures need to be taken with corrective and preventive actions (CAPAs).

Comparison of cleaning processes


7 min. reading time | by Torsten Knöpke

Nitrosamines: Authorities‘ Expectations and Typical Mistakes


8 min. reading time | by Sabine Paris, PhD


"Contaminants in medicinal products – focus on nitrosamines" was the title of an online training course organised by the German FORUM Institute on 12 November 2021. Four renowned experts from the authorities, industry and consulting shed light on all aspects of nitrosamines that play a role in the life cycle of a medicinal product:

9 Check Points for the Incoming Goods Protocol at the Logistician's or Wholesaler's Premises


8 min. reading time | by Simone Ferrante


Receipt of medicinal products

When materials or products are delivered, their quality is assessed. Therefore, this work step should be carried out by experienced and particularly reliable employees.

Update on Annex 1 of the EU GMP Guide


7 min. reading time | by Doris Borchert, PhD


The 27th PTS GMP Conference took place face-to-face and in parallel digitally from 30.11. to 01.12.2021 in Mainz, Germany. The hybrid event was broadcast live from the Atrium Hotel in Mainz, where most of the speakers were present in person.

The presentation by Rico Schulze, Saxon State Ministry for Social Affairs and Social Cohesion, on the revision status and publication of Annex 1 to the EU GMP Guideline was particularly eagerly awaited.

The GMP Regulations Report 2021


13 min. reading time | shortened version


From a regulatory perspective, the year 2021 had plenty in store. Parallel to the omnipresent COVID-19 pandemic, the authorities around the world managed to finalize draft documents that became “sideshows” while the pandemic took centre stage. What topics kept the GMP professionals on their toes?

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