Permitted Daily Exposure (PDE) reports for excipients and APIs
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).
This is what we need from you to prepare a PDE report:
- Name and address of the company
- Name of the API
- Dosage form
- Route of application of the API or of the potential next product that is produced in the same facility (cleaning validation)
Our service includes:
Issuing of the PDE report
- According to EMA guideline in English
- Issued on your company name according to EMA guideline requirements
- Issued by European toxicological experts
Any questions?
Please contact:
Cynthia Schulz, cynthia.schulz@gmp-publishing.com
+49 (0)7622 66686-70
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