Modern Qualification

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 12, Seite 1620 (2019))

Moelgaard G | Gengenbach R

Modern Qualification / Are you ready for this opportunity together with your suppliers? · Moelgaard G, Gengenbach R · ¹Moelgaard Consulting, Lyngby, Denmark und gempex GmbH, Mannheim, Germany
In einer Zeit, in der die pharmazeutische Herstellung und insbesondere die Qualifizierung und Validierung pharmazeutischer Einrichtungen und Verfahren zunehmend unter Druck geraten, ausgelöst durch neue internationale Vorschriften, neue innovative Produkte und einem verstärkten Wettbewerb z. B. im Bereich der Biosimilars, ist es notwendig geworden, den traditionellen Qualifizierungs- und Validierungsansatz neu zu überdenken. Viele deutsche und europäische Unternehmen folgen noch immer veralteten Verfahren und Projektabläufen, was sich in Anlagen äußert, die Monate früher hätten in Betrieb gehen können, hätte man bereits die moderneren, zeit- und kosteneffizienten Vorgehensmodelle berücksichtigt. Ein kürzlich veröffentlichter Leitfaden zu moderner Qualifizierung zeigt Möglichkeiten auf, wie eine gute Zusammenarbeit ...

2025: Pharmaceutical Technology and Manufacturing Solutions for Facilities of the Future

Rubrik: Leitartikel

(Treffer aus pharmind, Nr. 12, Seite 1610 (2017))

Moelgaard G

2025: Pharmaceutical Technology and Manufacturing Solutions for Facilities of the Future / Moelgaard • Pharmaceutical Technology · Moelgaard G · Moelgaard Consulting, Lyngby, Denmark
Disruption in the pharmaceutical industry? It may be hard to imagine but many industries have been undergoing disruption of their businesses in the past and even more will in the future. Think typewriters, film cameras, diskettes or paper-based maps as well as many examples of technology-based disruption but can this happen in pharma? Dosage forms have not changed much since the first industrial tablets and the first injectable drugs in the early 1990s. Yet we could be approaching a new revolution in pharmaceutical products that may disrupt the current product portfolio as well as the current manufacturing technologies. We still ...

The Need for Agile Facilities in the Future Pharma Reality

Rubrik: Biotechnologie

(Treffer aus TechnoPharm, Nr. 05, Seite 250 (2015))

Munk M | Moelgaard G

The Need for Agile Facilities in the Future Pharma Reality / Munk and Moelgaard • Need for Agile Facilities · Munk M, Moelgaard G · NNE Pharmaplan GmbH, Bad Homburg
single-use technology continuous manufacturing biopharmaceutical facilities flexible facilities biotech manufacturing The pharmaceutical industry is going through interesting but also challenging years. Global competition and regulatory requirements are increasing and both recent patent expirations and pressure to reduce the cost of healthcare have become parts of the new pharma reality. Worldwide operations have considerably increased the complexity of supply chains. Meanwhile, next generation therapeutic approaches such as cell and gene therapy entail a complete change in the pharmaceutical industry’s traditional manufacturing paradigm. In order to stay competitive, companies are looking for ways to improve operations without compromising the high standards of ...