Toxicology knowledge Team Sweden AB

Drug manufacturing support

Introduction:

Drug manufacturing are subjected to rules and regulations to ensure high quality of the drug product and to help keep both patients and workers safe. Regulatory exposure limits, e.g. acceptable levels of impurities, permitted daily exposure values (PDE) and occupational exposure limits (OEL), and the methodology to obtain these are communicated in guidelines issued by authorities. 

The limits are based on scientific data obtained in experimental studies (proprietary data, or from the open literature) and/or data from in silico predictions, and are established by an expert in toxicology and risk assessment.

“In the support to clients, experience and scientific excellence makes all the difference.”

TKT provides risk assessment and determination of qualification limits of impurities and degradation products present in the drug substance (Active Pharmaceutical Ingredient) and drug product according to ICH Q3 guidance’s.

TKT also performs evaluation of the mutagenic potential of impurities, so called “Potential Genotoxic Impurity (PGI) assessment” in accordance to ICH M7 guidance.

TKT welcome any type of enquires within chemical risk assessment and provides expert opinion and recommendations on a case-by-case approach. TKT has extensive experience in risk assessment, including determination of OEL and PDE and risk assessment of food contaminants and extractables and leachables in material in contact with a drug product or from medical devices.

In some circumstances it is possible to utilize computer-based analysis in the chemical risk assessment. TKT offers predictions using the in silico tools Derek Nexus and Leadscope. Our clients have appreciated this type of analysis as they sometimes can be regarded as a plausible substitute for experimental data, saving both time and resources.

“In worst case, we would have faced a production delay, but the expert report from TKT was the key to success.”

Common queries to TKT

Q&A | E&L

We have received results from an E&L study. Can TKT  risk assess the leachables that have been found above the set limits for the device?

We have extensive experience in risk assessing extractables and leachables and can report results of the assessment(s) in formal reports, or, if wished, as a short memo. Our formal, signed, reports are ready to use in any regulatory submission/file, as they fully comply with the ISO 10993 standards. If needed, TKT will also provide regulatory accepted in silico/QSAR analyses. Welcome to contact TKT for further discussions on what assistance TKT can provide.