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.

Request a quote

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).

List of available APIs

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
Issued by European toxicological experts

Our customers are saying:

... many thanks for the professional support in this matter"

"... summarised very nicely"

"... we will be happy to come back to you in comparable situations"

"... worked out perfectly"

"... we appreciate the constructive collaboration with the colleagues from Azierta very much "

Request for Offer: Toxicological Assessments

Request a non-binding offer for one or more of our toxicological reports now.

Please inform yourself about the processing of your personal data in our Data Privacy Statement before sending the contact form.

Type of assessment *

PDE Report

OEL Report

Elemental Impurities Risk Assessment

Organic Impurities

Mutagenic Impurities

Environmental Risk Assessment (ERA)

API / Product / Contamination *

Dosage form *

Application way *

Comments, questions, suggestions

Prefix

First Name *

Last Name *

Company *

Street *

Postcode, City *

Country *

E-Mail *

Phone *

Fields marked with asterisks (*) are required.

Privacy*

By selecting continue you confirm that you have read and agree to our data protection information.

Do you have any Questions?

Talk to our customer advisors

Do you have any questions about our products? We are here to help.

Cynthia Schulz

cynthia.schulz@gmp-verlag.de +49 (0)7622 66686-70

PDE Report | Sample Document

Why do you need a PDE report? As of June 1st, 2016, health-based exposure limits must be determined for all APIs of human and veterinary medicinal products produced in multi-purpose facilities. >>> More information 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 Brief explanation/training of the report 10–15 minutes in English Conducted by a toxicologist via Skype after delivery This is what we need from you to prepare a quote: Company name and address Name of the API Dosage form Route of application of the API or of the potential next product produced in the same facility (for cleaning validation)

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€0.00 net excl. VAT

Details