RISK ASSESSMENT Services
What is Risk Assessment ?
Setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities is regulatory requirement for the pharmaceutical industry.
Permitted Daily Exposure (PDE) / Acceptable Daily Exposure (ADE) Calculations, through scientific toxicological risk assessment will be used while evaluating the risks of possible carryover contamination of residual active substances through medicinal product. Thus, derivation and establishment of Permitted Daily Exposure (PDE) for pharmaceutical manufacturing facilities, has become an integral part of cleaning validation to comply with various regulatory requirements.
OEL values as per sponsor requirement. PRADO is providing this service to many national and international pharmaceutical industries since last 5 years. PRADO has also supported many pharma companies establishing Acceptable Intake (AI) for the genotoxic impurities found in their medical products. PRADO’S Risk Assessment Services also include review of reports submitted to regulatory authority, preparation of investigational broacher. Thus, PRADO understands the importance of establishing Health-based Exposure Limits (HBEL) and supports the pharmaceutical industry.
PDE/ADE, OEL, AI Assessments
- PDE Evaluations
- OEL Values Determinations.
- Acceptable Intake Assessments
PDE/ADE, OEL, AI Assessments
● PDE, PD50 evaluations
● Acceptable Intake assessments
● OEL,NOEL,LOAEL values determinations.
Toxicity Evaluations for Formulations
● Inherent Toxicity.
● Acute Toxicity.
● Skin, Eye Irritation Potential.
● Skin Sensitisation.
● Reproductive, Genotoxic, Carcinogenic Aspects.
● Synergistic and Unpredictable Adverse Effects for Combinations.
Toxicological Assessment for Cosmetics
Exposure Consideration Evaluations
● Physical, Size, Volume
● Accessibility
● Intended Use