The guideline on setting health based exposure limits for use in risk identification for the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), which is supported by the Questions and Answers (EMA/CHMP/CVMP/SWP/246844/2018) and the Overview of Comments (EMA/CHMP/SWP/364535/2015) documents was implemented:
1st December 2015
For medicinal products introduced for the first time into shared manufacturing facilities.
1st June 2016
For manufacturers of products for human use already produced in shared manufacturing facilities (unless existing arrangements scientifically justified) including those who manufacture human and veterinary medicines using shared manufacturing facilities.
1st June 2017
For manufacturers solely producing products for veterinary use (unless existing arrangements scientifically justified).
To meet guidelines on shared facilities requirements within the deadlines imposed, we offer customized PDE monographs for all concerned products.
We have already developed a database containing more than 1,500 PDE monographs.
You can check Tox by Design methodology for PDE Monograph, which are duly validated and signed by an European Registered Toxicologist expert.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that Tox by Design is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using the Quotation Request below to receive a quotation for PDE Monograph for your Active Pharmaceutical Ingredient, New Chemical or Biological Entity or any Chemicals substances deployed in your GMP manufacturing lines.