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GMP LOGFILE: Lead Article

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?

How to Maintain the Qualification Status of Your Equipment


8 min. reading time |


The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned. This is ensured by regular calibration, maintenance, effective change management and periodic review.

Original Data and True Copies


6 min. reading time | by Christine Oechslein, PhD and Cornelia Wawretschek


For almost all purposes in the GMP sector, it is mandatory to use original data and documents or only true copies thereof. This requirement also forms part of the ALCOA principle. Since it is only possible in a few cases in operational practice to work with the sole original document, the question arises as to what requirements are to be placed on the requisite true copies (see definition in Figure 15.B-6). Figure 15.B-7 compares different types of copies with the concept of original data.

Supplier Qualification: Pre-Selection Process


7 min. reading time | by Stephanie Blum, PhD


If a new service or material is required, the competent department first checks whether this service or material can be obtained from an already qualified supplier. If this is the case, the department initiates a follow-up qualification. Otherwise, the identification and pre-selection of potential new suppliers is carried out by the department itself.

Process Models for the Validation of Excel Applications


8 min. reading time | by Thomas Trantow, PhD


Definition of the types of Excel applications

Responsible Person according to GDP at the Logistics Service Provider


8 min. reading time | by Simone Ferrante


In Europe, companies with a wholesale distribution authorisation, the management must appoint a responsible person who is responsible for the introduction and implementation of a quality management system and compliance with the GDP rules.

Cleanrooms: The Path from Concept to Qualified System


6 min. reading time | by Harald Flechl


Good Engineering Practice (GEP) for procurement

Beginning from the definition of the User Requirements Specification (URS) the planning phase is subdivided into four stages:

Smart Deviation Management – Vision or Reality?


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


The GMP-compliant and timely management of deviations is very often addressed in audits. One reason for this is that deviations reveal gaps in the defined quality systems or indicate that they have not been set up correctly.

Typical GMP Deficiencies at Manufacturers of Chemical APIs - An Overview


7 min. reading time | by Norbert Waldöfner, PhD


Figure 20.F-24 provides an overview of the GMP deficiencies that, in the author's experience, are frequently encountered during audits of active substance manufacturers.

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