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


Hanieh Mahdiani, Delaram Doroud, Maryam Shahali, Niloufar Pouyan, Fahshideh Brufar, Alireza Rahimi, Javad Vaez

Abstract


Objective: Qualitative risk assessment process is a new topic in the pharmaceutical industries. The main outcome of the risk assessment implementation is to help the manufacturers for a better decision-making, in a case that a quality problem arises. According to the ISO documents;  vials used in the pharmaceutical industry have a special dimension specification and Quality Control analytical results should prove that the vial samples are in the defined range. Nevertheless, the value of these tests is not the same as defined ISO specifications;  and this may have minor and/or significant impact on the final product quality.

Methods: The purpose of this qualitative study was to rank the results of the vial dimention tests based on quality risk assessment. Consequently, these rankings can help to decide whether the dimension deviation from quality specification of vials is acceptable and what will be the impact of accepting the risk on the final product safety and finally how to decrease the risk.

For this purpose, we consider the final product contamination could be one of the main indicators for the quality as the contamination from packaging materials in particular are more important when aseptic processing run.

Results: Dimensions that are directly associated with opening the vial containing d2, d3, d4 and h4 that they affect rubber sealing and capping. Other dimensions like h1, h2, h3 and d1 affect rubber sealing and capping indirectly. Therefore, these two groups of deviations have a very high probability of contamination.

 


Keywords


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

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References


- Guidance or industry, Q9 Quality Risk Management; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) , Center for Biologics Evaluation and Research (CBER); June 2006, ICH

- ISO 8362-1:2009, injection containers and accessories-part 1: injection vials made of glass tubing.

- L. Viornery, Ph. Le Goff,Quality risk management – implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S, version r1A0; 1.2010

- Benoît Verjans and Charles H. Reed, Assessing Filling Technologies For Contamination Risk; Dec. 2, 2011

- Applying a Risk Approach in the Simulation of Aseptic Filling of Vaccines | IVT network, Journal of GXP Compliance, May 30, 2013




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

306 Views | 125 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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