Potent Compound Corner

OEL / PDE Monographs: Criteria for Toxicology Partner Selection

When purchasing occupational exposure limits (OEL) and permitted daily exposure (PDE) monographs for active pharmaceutical ingredients, it’s important to select a toxicology partner with a quality-focused process. In this article we will explore the top criteria to consider when evaluating a toxicology service partner.

Criteria 1: experienced team of toxicologists, including DABTs and/or ERTs

Selecting a partner with certified toxicologists gives you the confidence you’re receiving quality occupational exposure limits (OEL) and permitted daily exposure (PDE) monographs. At Affygility Solutions, our quality-driven process begins with an experienced team. Each monograph is prepared by certified toxicologists, including DABTs and ERTs, with decades of pharmaceutical industry experience.

Criteria 2: quality assurance process when preparing OEL / PDE monographs

You want the certainty that you’re receiving thorough and complete OEL / PDE monographs. Affygility Solutions’ experienced team of toxicologists follows a quality-driven process to ensure they prepare and deliver comprehensive monographs. Affygility Solutions also has a 34-step quality assurance process to validate accuracy of all monographs.

Criteria 3: CPhI award-winning web-based ordering system

Accessibility and customer service are important aspects when selecting a toxicology partner. Affygility offers a CPhI award-winning web-based ordering platform, OEL Fastrac, for purchasing OEL / PDE monographs. The OEL Fastrac self-service ordering system is simple: browse the catalog of nearly 2000 existing monographs, click to order, provide payment information, and instantly download the OEL / ADE monograph in a convenient PDF format. With 24/7 availability and instant download capabilities, OEL Fastrac saves you time and money.

Criteria 4: compliance with international pharmaceutical regulations

There are an increasing number of complex regulations in the pharmaceutical industry. Your toxicology service partner needs to understand and maintain compliance standards. The Affygility team routinely reviews environmental, health and safety publications to determine regulatory impacts. Our OEL / PDE monographs comply with international regulations and are widely accepted by European Medicines Agency (EMA), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and Brazilian Health Regulatory Agency (ANVISA) authorities.

Criteria 5: free periodic updates on OEL / PDE monographs

It is important to consider the total cost of obtaining and maintaining compliant monographs. To comply with EMA requirements and PIC/S health-based exposure limit requirements, Affygility Solutions provides periodic updates on monographs at no additional cost. Customers are notified when a previously purchased OEL / PDE monograph is updated. Affygility Solutions also uses proprietary software tools to be alerted when new safety information becomes available that might impact the OEL or ADE calculations.

Criteria 6: ongoing and accessible support from toxicology team

Ongoing and free technical support from an experienced team of toxicologists are important components to ensure you comply with regulatory requirements. Affygility Solutions is available to answer your potent compound safety questions to demonstrate your compliance to auditors and regulatory agencies.

Criteria 7: proven track record of global toxicology experience

With growing complexities in the toxicology industry, it is important your toxicology partner has a long history of providing and supporting toxicology services. Affygility Solutions has been committed to providing service globally since 2002. This proven track record gives you peace of mind that you're receiving quality OEL / PDE monographs backed with exceptional support.

About Affygility Solutions

Since 2002, Affygility Solutions has been providing potent compound safety, occupational toxicology and industrial hygiene services to biotechnology, pharmaceutical and medical device companies throughout the world. With Affygility’s longevity in the toxicology industry, you can have confidence you are receiving OEL / PDE monographs you can trust in order to implement risk-management controls. Contact Affygility to discuss how we can become your trusted toxicology service provider.

Published February 7, 2021

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