Toxi Plan ensures the safety of your patients
When active pharmaceutical ingredients, APIs (Active Pharmaceutical Ingredients), drugs and veterinary products are manufactured on production lines, there is a risk of cross-contamination between active ingredients. This is known as the " risk of cross-contamination ". ⚠️
The risk for the patient is that residues of another drug's active ingredient may find their way into their own medicine, and that they may consume non-prescribed active ingredients.
SEARCH TOXICOLOGICAL DATABASES FOR YOUR ACTIVE INGREDIENTS
CALCULATING AN "MP" IN ACCORDANCE WITH ICH Q3C AND VICH GL 18
ENSURE THAT THE RISK OF CONTAMINATION IS ACCEPTABLE
HELPING TO ESTABLISH YOUR "MACO" (Maximum Allowable Carry Over).
"Our mission: to carry out pharmaceutical product evaluations on your behalf and help you ensure the safety of your patients."
Our team is made up of experts in biology, chemistry, ecology, ecotoxicology, pharmacology, REGULATORY AFFAIRS (ISO standards, etc.), safety assessment and TOXICOLOGY, whose qualifications are recognized in France and the rest ofEurope.
When inspecting pharmaceutical products, the toxicological assessments performed by our experts are as follows:
1. We search the various toxicological databases to ensure that we have all the information specific to your products.
2. We calculate a PDE. This is the specific dose of a substance that is unlikely to cause an adverse effect, if an individual is exposed to an equal or lower dose every day throughout life, in accordance with ICH Q3C and VICH GL 18.
3. We ensure that the risk of contamination is acceptable in relation to the residues found after the cleaning process in accordance with EU GMP guidelines (EMA).
4. Toxi Plan® helps you establish your MACO (Maximum Allowable Carry Over).
PDE carried out
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