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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.

Our service includes

  • 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

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

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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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. >>> 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)

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GMP Compliance Adviser | Free Demo Access

GMP Compliance Adviser | Free Demo Access

The world's largest GMP knowledge portal! The trial period is absolutely non-binding. It ends automatically after 7 days. How the GMP Compliance Adviser supports you GMP in Practice  The GMP Compliance Adviser covers a wide range of topics: in 21 chapters, you will find more than 5,000 pages of in-depth knowledge for your everyday GMP work.Here you will find expert knowledge from practical experience and requirements from the authorities' perspective: Quality Management, Quality Risk Management & Quality ControlPremises, Facilities & MediaQualification, Process Validation & Cleaning ValidationHygiene, Microbiology & MonitoringProduction, Sterile Production & PackagingStorage & TransportAudits and Supplier Qualification & Inspections and Drug SafetyDocumentationComputerised Systems & Data IntegrityActive Pharmaceutical Ingredients & Biotechnology GMP Regulations  All relevant national, European and international GMP regulations are available in the GMP Compliance Adviser. Our editorial team keeps track of changes and updates for you, so that you always have access to the latest versions: EU GMP Guide & EU directives Regulations for Germany, Switzerland and Austria Regulations governing medical devices FDA regulations and guidelines Guidelines from ICH, PIC/S and WHO Sample Documents In addition, the GMP Compliance Adviser contains many sample documents and practical examples that you can use: Sample SOPs Sample protocols Sample forms Case studiesBy the way – you can always ask our experts. Ask your specific questions directly. Receive personal answers.

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