Quality of Pharmaceuticals and Outsourcing

Rubrik: Fachthemen

(Treffer aus pharmind, Nr. 05, Seite 572 (2022))

Basu P | Friedli T | Calnan N

Quality of Pharmaceuticals and Outsourcing / Understanding the Inherent Risks to the Patient – Part 2*Part 1 of this article was published in Pharm. Ind. 84, no. 4, 449–460 (2022). · Basu P¹, Friedli T², Calnan N³ · Institut for Technology Management, University St. Gallen, ¹Mount Prospect (USA) und BioPharm Excel, St.Gallen (Switzerland) und Dublin (Ireland)
Some examples/reasons why there is risk of lack of control when manufacturing is outsourced are as follows: Pharmaceutical companies are supposed to conduct on-site audit of their suppliers of drug substances. But data show that American and European pharmaceutical companies are misinformed about the identity of the manufacturing site of 39 % of the drug substances they purchase from China (Andre, 2011). Many pharmaceutical companies select excipients, ingredients, or drug substance suppliers by testing samples against the pharmacopoeia, without seeing the manufacturing conditions. Widely different levels of purity and control of raw materials. US/EU pharma companies often fail to let their ...

Quality of Pharmaceuticals and Outsourcing

Rubrik: Fachthemen

(Treffer aus pharmind, Nr. 04, Seite 449 (2022))

Basu P | Friedli T | Calnan N

Quality of Pharmaceuticals and Outsourcing / Understanding the Inherent Risks to the Patient – Part 1 · Basu P¹, Friedli T², Calnan N³ · Institut for Technology Management, University St.Gallen, Mount Prospect (USA) und BioPharm Excel, St.Gallen (Switzerland) und Dublin (Ireland)
Pharmaceutical companies have traditionally preferred conducting R&D and drug manufacturing in-house. The main reason for that was that the pharma companies felt that if manufactured in-house, there would be better control of the quality of the product. In fact, some pharma companies, in support of their internal manufacturing competency, used to tout the concept “We make what we sell”. However, over the last couple of decades, pharma companies have increasingly outsourced product development and manufacturing functions to Contract Research Organizations (CRO) and Contract Manufacturing Organizations (CMO). In today’s challenging environment, aggressive cost control has become a common theme in the ...

21c Quality Management in the Pharmaceutical Industry

(Treffer aus Büchern)

The Journey from Compliance to Excellence Wie gelingt Qualitätssicherung und Operational Excellence im täglichen Pharmabusiness? Kenner der von Prof. Friedli herausgegeben Grundlagenwerke zur Operational Excellence lesen hier ...