Health based exposure limits have to be determined for all APIs of human and veterinary medicinal products produced in multi-purpose facilities.
The PDE reports must comply with the respective EMA guideline:
„Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA /CHMP /CVMP/ SWP/ 169430/2012) link to guideline
Currently, GMP-Verlag can supply PDE reports for more than 1,900 already available APIs and new APIs upon request.
OEL values can be derived for these APIs as well (see information about OEL categorisations).
1. Issuing of the PDE report
2. Brief explanation/training of the report (10-15 min) in English by a toxicologist after delivery of the report (via Skype)
Contractor in accordance with EU GMP Guide Chapter 7: Azierta Contract Scientific Support Consulting S.L., Vía de las Dos Castillas 33, Edificio 7-h,
28224 Pozuelo de Alarcón (Madrid), Spain
Our partner Azierta is the market leader in Spain for the preparation of toxicological assessments and employs approximately 15 toxicologists for the preparation of PDE reports, OEL categorisations or elemental impurities risk assessments. These are also successfully used by the industry in other European countries (e.g. Germany, Switzerland, Italy, Belgium) and have been accepted by the authorities.
Our customers say:
"... many thanks for the professional support in this matter"
"... we appreciate the constructive collaboration with the colleagues from Azierta very much"
"... summarised very nicely"
"... we will be happy to come back to you in comparable situations"
"... worked out perfectly"
We can also prepare permitted daily exposure reports for APIs not included in the list of available APIs.
We will be pleased to prepare a specific offer for you.
Please contact us:
Phone: +49 7622 6668670