Over the last 6 years IASON consulting has created more than 700 PDE documents for potential cross contaminants or proposed levels of an elemental impurity (exceeding PDE, ICH Q3D Guideline). Therefore, we possess both the experience and the capacity to quickly and efficiently evaluate vast amounts of substances.
Your company has special needs towards PDE creation or requires a very specific template to be used? At IASON consulting, we work on any template you provide. Alternatively, you may choose to use ours — for free, of course.
Our well networked consultants are always up-to-date with the latest regulatory requirements for PDE creation.
The PDE is the most common form of HBEL that inspectors encounter. When conducting an HBEL assessment, available data are interpreted and necessary uncertainty factors are applied via analysis by our experts. At IASON, our consultants with expertise in toxicology / pharmacology will summarise decisions, justification, and final HBEL value based on a comprehensive literature search. HBEL assessments are required for all active pharmaceutical ingredients and to ensure organisational and technical control measures for producing medicinal products in shared facilities. If control measures cannot adequately assure potential contamination, a dedicated facility may be needed. HBEL can also be used to justify carry over limits used in cleaning validation.
EMA/CHMP/CVMP/SWP/169430/2012 “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”
EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, Chapter 3 and 5
Note for Guidance on Impurities: Residual Solvents (CPMP/ICH/283/95 in conjunction with CPMP/ICH/1507/02, CPMP/ICH/1940/00 corr, CPMP/QWP/450/03, EMEA/CVMP/511/03 and CPMP/QWP/8567/99)
VICH GL18(R): Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/99-Rev.1)
Guideline on the Limits of Genotoxic Impurities (EMEA/CHMP/QWP/251344/2006 and CPMP/SWP/5199/02)
You may choose our IASON PDE or HBEL template style which has been specifically designed to meet international guidelines while maintaining a contemporary, clean, and pleasant look.
Any questions? Call us under: