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Investigating Combination Product Failures: Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates

Source :
Pharmaceutical Technology Europe. December, 2019, Vol. 31 Issue 12, p38, 1 p.
Publication Year :
2019

Abstract

Q:We have recently contracted with a client to manufacture a pre-filled syringe. Can you tell me what changes I should make to my investigation procedure when investigating deviations and complaints [...]

Details

Language :
English
ISSN :
17537967
Volume :
31
Issue :
12
Database :
Gale General OneFile
Journal :
Pharmaceutical Technology Europe
Publication Type :
Periodical
Accession number :
edsgcl.677405342