Overview

As global regulators turn towards health-based risk assessment strategies, the importance of toxicological risk assessment has increased in the pharmaceutical industry like never before. To achieve the safety of workers and patients, different health-based threshold limits should mandatorily be set. Thus, in the typical pharmaceutical manufacturing facility or contract manufacturing organization (CMO), Occupational safety (i.e. worker’s safety) and Product safety (i.e. patient safety) are given ardent importance. The challenge is for manufacturers to ensure that safety is protected and to validate whether it is aligned with individual Health Authority (HA) Good Manufacturing Practices (GMP).

By performing cross-contamination assessments (VICH GL 18, ICH Q3C), viz. Permitted Daily Exposure (PDE) limit calculation and Accepted Daily Exposure (ADE) calculation, for Active Pharmaceutical Ingredients (APIs), residual solvents calculation in ppm, the median lethal dose - LD50-calculation, and conducting health based risk assessments such as, occupational exposure limits (OELs), cleaning validations for equipment and occupational exposure bands (OEBs), Freyr assists organizations to meet the necessary safety values required of manufacturing facilities for end-to-end compliance.

 

 

Freyr Expertise

Product Safety

  • Clear-cut understanding of the European Medicines Agency (EMA) Good Manufacturing Practice (GMP) guidelines to calculate health-based exposure limits
  • Comprehensive knowledge on calculation/derivation of no-observed-adverse-effect level (NOAEL), no observed effect level (NOEL) and lowest-observed-adverse-effect-level (LOAEL)
  • Calculating Permitted Daily Exposure (PDE) for APIs
  • Calculation/derivation of:
    • Accepted Daily Exposure (ADE)
    • Threshold of Toxicological Concern (TTC)
    • the median lethal dose (LD50)
    • residual solvents and impurities in PPM
  • Monitoring levels of the cleaning validation for a huge set of medicinal products from various shared facilities
  • Access to toxicological literature
  • Establishing permitted daily exposure (PDE) for solvents and impurities
  • Support for impurity qualification for solvents (ICH, Q3C) and elemental impurities (ICH, Q3D)
  • Derivation of PDE for other routes of drug product administration and further qualification of impurities
  • Streamlined data collection to be incorporated into PDE reporting requirements
  • Technical and protocol support for cleaning validation

Occupational Safety

  • Calculating occupational exposure limit (OEL) value (not mandatory for Pharma manufacturing unit, but occupational exposure values (OEVs) are still established by the manufacturing units for pharmaceuticals, in-order to assure safety of workers at work place)
  • Establishing occupational exposure bands (OEBs)
 

Freyr Advantages

  • Qualified, trained and experienced toxicologists and data scientists who come from diversified fields of toxicological research and have through understanding of risk assessment
  • Freyr has staff with a first-hand experience in working in Good Laboratory Practice (GLP) environment as study director and also have a fair understanding of manufacturing process and Good Manufacturing Practice (GMP) requirements
  • Robust quality control system associated with Regulatory writing experts which assures delivery of documents which are scientifically correct and audit/submission-ready
  • Freyr has expert team which can deliver documents almost half of the time which is required in the industry for the same task