Environmental Risk Assessment. ERA reports

In accordance with Article 8(3) of Directive 2001/83/EC, an application for a marketing authorisation for a medicinal product for human use must be accompanied by an Environmental Risk Assessment (ERA). This assessment should be performed according to the European Medicines Agency, following the procedure described in Guideline on the Environmental Risk Assessment of Medicinal Products…

Phases in the evaluation of the occupational exposure to chemical substance/API. Phase 3: Quantitative evaluation of the risk of inhalation.

After the banding control has been established along with the strategies to be followed, it is necessary to carry out a control of the exposure and establish corrective measures (depending on the “Risk Factors” and their priority). A quantitative evaluation of the exposure must be done to check the corrective measures. To this end, we…

Phases in the evaluation of the occupational exposure to a chemical substance/API. Phase 2: Occupational exposure band-technical measures

After calculating the OEL and categorising the substance, the Occupational Exposure Band (OEB) must be obtained that will define the technical and organisational measures to be taken into account. Control banding is defined by the NIOSH as a process in which a single technological control measure (such as general ventilation or containment) is applied to…

Phases in the evaluation of the occupational exposure to a chemical substance/API. PHASE 1: Risk detection and initial assesment.

The aim of the hazard assessment is to determine the classification and labelling of the substance and to establish the concentration in the air of that substance at which it is considered that approximately almost all workers can be repeatedly exposed (day after day, in a job done throughout their life) without adverse effects; the…

Key factors for the implementation of directive ICH Q3D on elemental impurities

ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines. There are 4 issues to be taken into account before starting the risk analysis:   The strategies that we follow will largely depend on the suppliers’ baseline information. The number of products requiring risk analysis, which will also…

PDE calculation in shared facilities for veterinary medicaments

1. Introduction On June 2016 will be coming into effect for veterinary medicaments EMA’s guideline (EMA/CHMP/CVMP/SWP/169430/2012) already implemented for human medicaments. This document follows the review of chapter 3 and 5 (currently into effect since March 2015), with the purpose of determine a new risk analysis methodology for shared facilities: It is necessary a dedicated…