Quality Surveillance in the Supply Chain of API

Rubrik: Fachthemen

(Treffer aus pharmind, Nr. 06, Seite 815 (2015))

Vogels P

Quality Surveillance in the Supply Chain of API / Risks and Challenges for the ‘Qualified Person' · Vogels P · Meda Manufacturing GmbH, Köln
In 2008, unexpected reactions were reported during the application of a heparin sodium injection. Hundreds of people died in the United States. During the investigation it was detected that heparin was contaminated with oversulphated chondroitin sulphate (OSCS) causing the adverse drug reaction. The Active Pharmaceutical Ingredient (API) was manufactured by the Scientific Protein Laboratories-Changzhou, China. This is a shattering example of how contaminated API could pose a big harm on the health of patients and, ultimately, could lead to death. Beside that, the business impact of the marketing companies was huge. This might also occur when a contaminated product is ...

Preventive Maintenance in GMP

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 03, Seite 358 (2015))

Vogels P

Preventive Maintenance in GMP / A current status quo orientation · Vogels P · MEDA Manufacturing GmbH, Cologne, Germany
“Maintenance engineers are the unsung heroes of the pharmaceutical production process.” (Martin Brown, Jim McCabe) This more or less provocative statement of Martin Brown and Jim McCabe refers to two aspects: After having completed the project, it is the task of the maintenance engineers to mitigate the risks along with ongoing manufacturing operations facing a limited budget and being under strict cost control and maintenance engineers are working effectively in the background without attracting awareness during the operation and/or inspections. BUT: Is this true? Does maintenance have this importance in pharmaceutical operations and is maintenance out-of the inspectors' focus? ...