Permitted Daily Exposure (PDE) reports for APIs

 

As of June 1st 2016, 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, Maas & Peither can supply PDE reports for more than 1500 APIs.
Further reports will be available shortly. OEL values can be derived for these 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)

 

 Request your quote now!

 

Information to print:   PDE report - request for quote    List of available APIs


Our service includes:

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


Pricing:

  • PDE reports for available APIs:
    500.00 EUR net per API
  • PDE reports for APIs not yet available:
    price available upon request
     

List of available APIs

If you order a PDE report and an OEL categorisation together, you will receive both reports at the following prices:

  • Combination of PDE report and OEL categorisation for available APIs:
    800.00 EUR net per API
  • Combination of PDE report and OEL categorisation for APIs not yet available:
    price available upon request

Why can we offer PDE reports for such a competitive price?

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"


Do you need reports for other APIs?

We can also prepare PDE 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:

Cynthia Schulz

Phone: +49 7622 6668670
E-Mail: cynthia.schulz@gmp-verlag.de

 

 Request your quote now!