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OEL Categorisation | Sample Document

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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.

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  • extensive bibliographic research
  • OEL determination according to internationally accepted guidelines
  • Categorisation with regard to the specific working conditions according to national requirements or SafeBridge® banding scheme

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  • Company name and address
  • Name of the API

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Cynthia Schulz, Vertrieb und Key Account für Toxkologische Gutachten beim GMP-Verlag

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Cynthia Schulz

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

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Elemental Impurities Risk Assessment | Sample Document

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 Dalia 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. Request a 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 Request a quote

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PDE Report | Sample Document

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.Our service includes Issuing of the PDE reportAccording to EMA guideline in EnglishIssued on your company name according to EMA guideline requirementsIssued by European toxicological expertsThis 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) Request a quote

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GMP Compliance Adviser | Free Demo Access

GMP Compliance Adviser | Free Demo Access

You will receive your login credentials via email. Throughout the week, you will receive further information about GMP Compliance Adviser directly in your inbox. Customer support is available to assist you at any time. You can also direct questions about the content to the editorial team and receive personalized responses. You do not need to cancel your demo access. The free access will end automatically. Advantages at a glanceSpecial Offer as Part of Your Free Demo Access:Select one of the 21 chapters from the GMP in Practice section of the GMP Compliance Adviser—we’ll grant you full access to it until the end of your trial period. This allows you to delve deeply into the topic that’s most relevant to your daily practice. Take this opportunity to experience the in-depth technical content, practical explanations, and comprehensive expert knowledge the GMP Compliance Adviser has to offer—and see the tangible added value it brings to your work.

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