|
Implementation of ICH Q3D guideline for elemental impurities in a Moroccan pharmaceutical industry: case of liquid drug product
|
|
| Author:
|
M. BENABBES, H. ELFROM, K. AZMANY, R. LAMRINI, M. BOUATIA
|
| Abstract:
|
The objective of the present paper is to provide a practical example of risk assessment of elemental impurities (EIs) in final drug product according to the new ICH guideline Q3D on EIs. This EIs may arises from various potential sources such as excipients, water, APIs, container systems and manufacturing processes. The assessment strategy is performed on four steps: Identification of the potential sources, analysis of EIs that may be introduced by each source, evaluation of predicted levels of EIs and comparison against the established values and definition of the control strategy. The Haloperidol 2% oral solution served as model. For this pharmaceutical form, five elements were considered: cadmium, lead, cobalt, vanadium, nickel and intentionally added elements.
The amount of EIs more than 30% of the permitted daily exposure (PDE) should be monitored. Our outcome indicates that the test results of studied EIs are maintained below 30% of PDE and are within the acceptance criteria as per ICH Q3D. As a result, no additional control over the finished product is needed. The haloperidol 2% oral solution was safe for human consumption. This approach has allowed to reduce and even more to eliminate the control of EIs in the drug product.
|
| Keyword:
|
ICH Q3D guideline, Elemental impurities, Risk assessment.
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2020.SP1.141
|
| Download:
|
Request For Article
|
|
|