Collation, Compilation and Comparison of GLP Compliance Requirements to Support Regulatory Approvals for Select Category of Pharmaceutical Products in Selected Countries

The present study activity to shed light on to the role of the GLP inspections which is helps to overcoming non-compliance activity. The objective of the present study is to identify the GLP inspection and understanding the underlying concepts for GLP compliance for licenses pertaining to Pre-Clinic...

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Veröffentlicht in:International Journal of Pharmaceutical Quality Assurance 2019-05, Vol.10 (1)
Hauptverfasser: V., Balamuralidhara M., Devaraju, Kaushik, S., Karthik, Venkatesh, M. P.
Format: Artikel
Sprache:eng
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Zusammenfassung:The present study activity to shed light on to the role of the GLP inspections which is helps to overcoming non-compliance activity. The objective of the present study is to identify the GLP inspection and understanding the underlying concepts for GLP compliance for licenses pertaining to Pre-Clinical study. The study compared and contrasted the GLP requirements and their inspection procedure of the regulatory authorities in India, EU and Singapore.
ISSN:0975-9506
0975-9506
DOI:10.25258/ijpqa.10.1.32