PDE Report | Sample Document

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Review with rating of 5 out of 5 stars

Great information

Mohammed Abdalla Zayed

4 Jul 2022

Review with rating of 5 out of 5 stars

risk assessment

Wei Shao

28 Oct 2020

Product type

E-book

Are you not quite sure what a PDE report looks like and would like to take a look inside?

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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.

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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)

Do You Have Questions?

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

Cynthia Schulz

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

Customer Reviews

2 reviews

Average rating of 5 out of 5 stars

Leave a review!

Share your experiences with other customers.

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Display reviews in current language only.

Review with rating of 5 out of 5 stars

Great information

Mohammed Abdalla Zayed

4 Jul 2022

Review with rating of 5 out of 5 stars

risk assessment

Wei Shao

28 Oct 2020

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Why do you need OEL categorisations? For every API, an upper limit on the acceptable concentration in workplace air has to be determined (OEL). For this determination, toxicological and pharmacological properties of the API are analysed and related to preventive measures.Our service includes extensive bibliographic researchOEL determination according to internationally accepted guidelines Categorisation with regard to the specific working conditions according to national requirements or SafeBridge® banding scheme This is what we need from you to prepare a quote Company name and address Name of the API

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Elemental Impurities Risk Assessment | Sample Document

Why do you need an elemental impurities risk assessment? As of June 2016, all new medicinal products have to be evaluated based on the ICH guideline Q3D on elemental impurities. As of December 2017, this guideline came into effect for already authorised medicinal products as well. Therefore, every authorised medicinal product has to be evaluated. How to obtain an elemental impurities risk assessment? The proven and successful collaboration between Azierta and GMP-Verlag Peither AG provides you with an economically priced alternative to conventional elemental impurities risk assessments. Following verification of the critical key data, we will be pleased to send you a binding, fixed price quote. Our service includes Issuing of the elemental impurities risk assessment According to ICH Q3D guideline in English Issued for the specific medicinal product according to ICH Q3D guideline Issued by European toxicological experts This is what we need from you to prepare a binding, fixed price quote Company name and address Name of the medicinal product

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