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About this article

Title

A PRACTICAL RISK-BASED APPROACH TO ASSESS VIAL’S DIMENSIONS DEVIATIONS EFFECT ON THE ASEPTIC FILLING PROCESSING, ACCORDING TO ICH Q9 GUIDELINE

Keywords

Quality Risk Assessment, Vial Dimension, Aseptic Filling Processing, ICH Q9, ISO 8362-1.

Date

01-10-2014

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 6, Issue 9, 2014 Page: 613-616

Online ISSN

0975-1491

Statistics

293 Views | Downloads

Authors & Affiliations

Hanieh Mahdiani
Quality Assurance Department, Production and research Complex, Pasteur Institute of Iran
Iran, Islamic Republic of

Delaram Doroud
Quality Assurance Department, Production and research Complex, Pasteur Institute of Iran
Iran, Islamic Republic of

Maryam Shahali
Quality Control Department, Production and research Complex, Pasteur Institute of Iran
Iran, Islamic Republic of

Niloufar Pouyan
Quality Assurance Department, Production and research Complex, Pasteur Institute of Iran
Iran, Islamic Republic of

Fahshideh Brufar
Quality Assurance Department, Production and research Complex, Pasteur Institute of Iran
Iran, Islamic Republic of

Alireza Rahimi
Recombinant Products’ Formulation Filling and Packaging Department, Production and research Complex, Pasteur Institute of Iran
Iran, Islamic Republic of

Javad Vaez
Commercial Department, Production and research Complex, Pasteur Institute of Iran.
Iran, Islamic Republic of


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