PTM & S-IN: un servizio completo per la gestione del rischio Nitrosammine
PTM Consulting and TOXIT provide the complete service for identifying and preventing unacceptable levels of nitrosamine impurities in drugs.
From September 2019 onwards, date of first issue of the “Information on nitrosamines for MAHs” by EMA, PTM consulting has supported Marketing Authorization Holders (MAHs) as well as DP and API manufacturers in “Step 1 Risk Evaluation” activities to define priority (Prioritization step) and to assess the potential risk of N-Nitrosamine presence and/or formation in finished products according to ICH Q9 and ICH M7 principles and Health Authorities (HAs) directives on N-Nitrosamine (Risk Evaluation step).
Moreover, PTM support for “Step 2 confirmatory testing” is addressed to assist MAHs
- in the search and management of external laboratory acting as facilitator between MAH and laboratory during screening testing and method validation activities (e.g. analytical protocol and report review)
- in choice of representative batches to be analyzed and in the definition of the number according to what recommended by HAs
- in preparing supportive documentation for the response to HAs.
With the experience gained in QRM through the years and in N-Nitrosamine topic, PTM consulting can actively manage Step 1 and Step2 activities.
Fore more information visit our web site or contact Giorgio Kyriacatis
To support the identification of your compound-specific Acceptable Intakes for N-nitrosamines in compliance with the regulatory requirements, TOXIT handles the following activities, based on in silico methodologies:
- Database search and assessment of existing carcinogenicity data
- Use of in silico approaches to perform expert SAR analysis and identification of similar structures with available carcinogenicity data
- Derivation of a scientifically justified Acceptable Intake.