Risk Assessment.

The published and proprietary toxicological data for the drug of interest and surrogate molecules are being thoroughly evaluated in order to undertake hazard analysis, assist product regulatory compliance, and perform product safety risk assessment

Health Based Exposure limits (PDE/ADE/OEL/OEB/ADI)

Occupational exposure limits (OELs) for contaminants (detergents, intermediates, etc.) and active pharmaceutical ingredients (APIs) in multipurpose pharmaceutical and chemical plant manufacturing operations
Health-based exposure limits (HBELs) and carrying out scientifically supported risk assessment to establish Permitted Daily Exposure (PDE)/Acceptable Daily Exposure (ADE).
Assigning of APIs/Chemicals to Occupational Exposure Bands (OEBs) as per OSHA/NIOSH standards
Applicable regulations: Annex 15 of the EU GMP Guide and EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA/CHMP/ CVMP/ SWP/169430/2012)

Impurities Risk Assessment

Drug substances (ICH Q3A R2) and Drug Products (ICH Q3B R2)
Residual solvents (ICH Q3C R8), and Elemental impurities (ICH Q3D R1)
DNA reactive (mutagenic) impurities (ICH M7 R1)
oncology products (ICH S9)

Toxicology Risk Assessment

Extractables & Leachables (E&L): Polymers (such plastic or elastomers), metal, or glass are frequently utilized as raw materials to create medical equipment, processing apparatus, and container closure systems (CCS). (guideline - US FDA, EMA, PQRI, PDA)