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 2,500 already available APIs and new APIs upon request.
OEL values can be derived for APIs as well (see information about OEL categorisations).
Issuing of the PDE report
Contractor in accordance with EU GMP Guide Chapter 7: Azierta Life Sciences & Health Consulting Firm S.L., Vía de las Dos Castillas 33, Edificio 7,
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"
Please contact us:
Phone: +49 7622 6668670
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