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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).
7 min. reading time | by Alexandra Fürst
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.
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.
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.
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).
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:
8 min. reading time | by Simone Ferrante
When materials or products are delivered, their quality is assessed. Therefore, this work step should be carried out by experienced and particularly reliable employees.
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.
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?
8 min. reading time | GMP-Verlag
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.
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.
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.
8 min. reading time | by Thomas Trantow, PhD
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.
6 min. reading time | by Harald Flechl
Beginning from the definition of the User Requirements Specification (URS) the planning phase is subdivided into four stages:
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.
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.
6 min. reading time | by Sabine Paris, PhD
The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.