The aim is to gain insight into the various aspects of the regulations of good manufacturing practice based on Dutch and European rules (Volume 4) and the impact these regulations have on the actual production of drugs. The current philosophy of quality management and quality systems as laid down in the ICH documents Q8, Q9 and Q10 will be discussed. On the basis of Annex 13 (Manufacture of investigational medicinal products) important aspects such as documentation, the determination of specifications, procedures and change control will be discussed. The various parts of validation will come up with Annex 15. Conditions as to production and sterilization will be discussed on the basis of Annex 1. The participants will develop a production process and validate it under GMP to prepare this process for inspection.
Study load
1 ECTS credit points
Calendar
Once every two years
Next course in 2012; to be announced
Registration
Ms. M.H. (Maaike) Bansema (m.h.bansema@med.umcg.nl)
Phone: +31 50 363 8409
Coordinators
H. (Hans) van Doorne, PhD
prof. H.W. (Erik) Frijlink
Additional information
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