Drug Product Development

Pharmaforum APV � � Drug Product Development � FS 22

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Allgemein Infos/Allgemein Alte Pr�fungen - BSc Pharmazeutische Wissenschaften 1. Jahr Allgemeine Chemie Organische Chemie I Organische Chemie II Einf�hrung in die Pharmazeutischen Wissenschaften I/II Grundlagen der Biologie I Grundlagen der Biologie II Mathematik I/II Physik I/II Physik II Statistik I Alte Pr�fungen - BSc Pharmazeutische Wissenschaften 2. Jahr Grundlagen der Informatik Statistik II Grundlagen der Biologie III Systematische Biologie: Pflanzen Anatomie und Physiologie I Anatomie und Physiologie II Histologie Pharmazeutische Analytik I Pharmazeutische Analytik II Physikalische Chemie Alte Pr�fungen - BSc Pharmazeutische Wissenschaften 3. Jahr Biopharmazie Galenik Gentechnologie Immunologie Medizinische Chemie Pathobiologie Pharmazeutische Biologie Pharmakologie und Toxikologie Qualit�tsmanagement Radiopharmazie Klinische Chemie I Drug, Safety & Public Health Medizinische Mikrobiologie Praktikum Mikrobiologie Computer Assisted Drug Design - CADD Therapeutic Proteins Galenics Pharmacoepidemiology & Drug Safety Pharmacology & Toxicology III Quality Management & Production I Quality Management & Production II Drug Product Development Therapeutic Skills Clinical Chemistry II

#1 | FS 22 datum

26.04.2022 10:14

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#2 | RE: FS 22 datum

26.04.2022 16:14

*First easy small talk, Schmidt and Schneider were very easy going...
*Exam duration: 12 min.

Lyophilization/freeze drying

- What is it for
- Pros. and Cons.
- Describe the process
- Name main components of the lyophilizator
- How is the lyophilizator cleaned (CIP, SIP)
- How do you validate the cleaning process (color bomb)
- Imagine you are a project leader, why would you decide going for a lyophilized product instead of a liquid formulation?

Good luck!

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#3 | RE: FS 22 datum

26.04.2022 16:42

Single-Use Technology (SUT)

What is SUT?
What 4 main challenges do we face with SUT? -> Single-use (environment, waste, recycling), leachables, absorption/adsorption, supply chain
-> explain a little bit about these 4 issues and how you might solve them (QC for leachables, supply chain resilience, etc.)

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FS 23 � � FS 24