KJREDY BIOSCIENCES Private Limited
Computational Toxicology, cross Contamination and Risk Assessments
Computational Toxicology – KJ REDY BIOSCIENCES
In addition to degrading the quality of the product, contaminants, small process impurites & nitrosamine drug substances-related impurites (NDSRIs) in cosmetic, agrochemical, pharmaceutical ingredients (API), or pharmaceutical products, including extractables and leachables, pose significant hazards to the patient community. In order to regulate and/or limit its consumption at harmful levels, toxicological risk assessment of impurities is crucial, particularly when dealing with probable genotoxic and carcinogenic impurities. Concerning the above stated contaminants, toxicological risk assessments are systematic scientific procedures that include risk assessment and hazard identification. Toxicological risk assessment services cover such evaluations using verified and approved ICH M7 guidelines. Under this service,our team provides global customer service by addressing issues with toxicological contaminants, risk & safety evaluations pertaining to pharmaceuticals, agrochemicals, medical devices, cosmetics, residual solvents, elemental and process impurities.
Cross-Contamination and Risk Assessments
A great deal of significance has been put on the pharmaceutical manufacturing facility, also known as the contract manufacturing organisation (CMO), occupational safety, or worker safety, and product safety, or patient safety. Manufacturers face a problem in ensuring the safety of their products and determining while their practices comply with defined Good Manufacturing Practices (GMP) promulgated by the Health Authorities (HA). KJREDY BIOSCIENCES helps organisations to meet the safety principles needed by manufacturing facilities for from start to finish compliance through the execution of cross-contamination assessments, such as calculating the limits of permitted daily exposure (PDE) and accepted daily exposure (ADE), active pharmaceutical ingredients (APIs), and performing health-based risk assessments, such as occupational exposure limits (OELs), cleaning validations for equipment, and occupational exposure bands (OEBs)
Computational Toxicology
• Toxicological risk assessment with end points viz., (carcinogenicity, mutagenicity, genotoxicity, skin sensitization, teratogenicity, irritation, respiratory sensitization, reproductive toxicity) and derivation of acceptable daily intake (ADI).
• QSAR evaluation by using well-validated and regulatory-accepted software tools by ICH M7.
• In silico prediction on toxicological concern and risk of formation of nitrosamine contaminants.
• Expert reports generated by ICH M7 with complete supporting data/information.
• Support for impurity qualification for solvents (ICH, Q3C) and elemental impurities (ICH, Q3D).
Cross-Contamination and Risk Assessments
• Calculation of health-based exposure limits as per EMA and GMP guidelines.
• Derivation of no-observed-adverse-effect level (NOAEL), no observed effect level (NOEL) and lowest-observed-adverse-effect-level (LOAEL).
• Access to toxicological literature and calculation of permitted daily exposure (PDE) for APIs.
• Derivation of PDE for other routes of drug product administration.
• Streamlined data collection to be incorporated into PDE reporting requirements.
• Derivation of accepted daily exposure (ADE), threshold of toxicological concern (TTC), the median lethal dose (LD50), residual solvents & impurities (ppm
• Monitoring levels of the cleaning validation for pharmaceutical products.
• Technical and protocol support for cleaning validation.
• Calculating occupational exposure limit (OEL) value and establishing occupational exposure bands (OEBs).
