Peer-Reviewed Journal Details
Mandatory Fields
Pembroke, JT
2008
Biochemistry And Molecular Biology Education
Introducing principles of validation into biochemistry and biotechnology courses - Practical concepts and a framework for active learning
Published
()
Optional Fields
validation regulatory issues methodology PHARMACEUTICAL INGREDIENTS MANUFACTURING PLANTS
36
1
70
75
Although undergraduate biochemistry and biotechnology courses teach the concept of accuracy and precision during practical laboratory sessions, the formal teaching of validation methodologies receives little attention. An increasing number of biochemistry and biotechnology graduates are finding work in industry in the area of industrial validation associated with biopharmaceutical, diagnostics, biomedical device, and pharmaceutical validation. We have introduced a structured introduction to validation into our undergraduate industrial biochemistry programme to illustrate the importance of validation within a framework of good manufacturing practice (GMP) and to show how validation is essential for regulatory compliance.
1470-8175
10.1002/bmb.130
Grant Details