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

摘要

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.