Potent Compound Corner

Seven tips to help prevent regulatory audit findings related to HBEL documentation

Every manufacturer of medicinal or veterinary products needs to obtain and keep current health-based exposure limits (HBELs), also known as acceptable daily exposure (ADE) limits or permitted daily exposure (PDE) limits, for all their products. With increased globalization of pharmaceutical manufacturing and the rising number of regulatory audits, facilities need the right toxicology partner to ensure compliance with complex international pharmaceutical standards and guidance. Let’s explore preventative actions to consider.

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Top 7 preventative actions for a regulatory audit

1. Select a toxicology partner who understands and complies with complex pharmaceutical regulations

There are an increasing number of complex regulations and guidance regarding health-based exposure limit (HBEL) values in the pharmaceutical industry. Your toxicology service partner needs to understand and maintain regulatory compliance standards with a quality-driven process. Partnering with a knowledgeable partner will help you navigate regulatory audits and minimize your risk. The Affygility Solutions’ team routinely reviews regulatory publications to determine regulatory impacts. In addition, Affygility’s personnel are frequent attendees and speakers at related industry conferences. You can trust that Affygility is always at the forefront of knowledge regarding HBEL requirements and practices. Affygility’s occupational exposure limit (OEL) and ADE/PDE reports comply with international regulations and are widely accepted by European Medicines Agency (EMA), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Brazilian Health Regulatory Agency (ANVISA), and the World Health Organization (WHO) authorities.

2. Increase your understanding of high potent (HPAPI) compounds and the impact in your facility

Based on 2021 data, the percentage of drug compounds that are considered highly potent is approximately 41%. This percentage is based on a review of over 1,900 OEL Fastrac monographs in Affygility’s online catalog that have OELs less than 10 µg/m3. This represents over a 15% increase in the previously reported number that was based on outdated 2013 data. The impact that increasingly more highly potent compounds have on the pharmaceutical industry is significant and can include additional engineering controls, more elaborate cleaning procedures, and sensitive analytical equipment to detect very low cleaning limits.

3. Be aware of the total cost of obtaining and maintaining compliant OEL/ADE/PDE reports

To comply with EMA requirements and PIC/S health-based exposure limit requirements, Affygility provides periodic updates on OEL/ADE/PDE monographs at no additional cost. Customers are notified when a previously purchased OEL/ADE/PDE report is updated. Be aware that low-cost providers do not supply free updates which could lead to non-compliance and increased cost.

4. Have ongoing and free technical support at your fingertips

Affygility is available to answer potent compound safety questions to demonstrate your compliance to auditors and regulatory agencies. Affygility provides online support from an experienced team of toxicologists to help you during a regulatory audit. This support is an important component to ensure you comply with regulatory requirements.

5. During a regulatory audit, you may need instant access to OEL/ADE/PDE reports

Affygility offers a CPhI and HPAPI award-winning web-based ordering platform, OEL Fastrac, for purchasing OEL/ADE/PDE monographs. The OEL Fastrac self-service ordering system is simple: browse the catalog of nearly 2,000 existing monographs, click to order, provide payment information, and instantly download the OEL/ADE/PDE monograph in a convenient PDF format. With 24/7 availability and instant download capabilities, OEL Fastrac saves you time and money.

6. Make sure your toxicology partner has the right team in place.

At Affygility, each monograph is prepared by certified toxicologists, including DABTs and ERTs, with decades of pharmaceutical industry experience. This experience helps ensure you’re compliant during a regulatory audit. Low-cost providers don’t always have certified toxicologists, or they have allowed their certifications to lapse, putting you at risk. When selecting a toxicology partner, ask to receive scanned copies of all DABT and/or ERT certificates, and ensure they are current. If there are any questions concerning the validity of a certificate, you can always reach out to the American Board of Toxicology or the Federation of European Toxicologists & European Societies of Toxicology for verification.

7. Understand potential hazards with natural health products

The natural health product (NHP) market is growing and there are often misconceptions about hazards with these products. Natural does not always equal safe. Based on guidance from EMA and PIC/S, HBELs should be established for all medicinal products, including NHPs. Furthermore, the toxicological data, on which the HBEL calculation relies, requires periodic reassessment throughout a product’s lifecycle. As a response to the growing nutraceutical and herbal medicinal market, Affygility added NHP HBEL monographs to its web-based ordering platform, OEL Fastrac.

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/ADE/PDE monographs you can trust to implement risk-management controls. Contact Affygility to discuss how we can become your trusted toxicology service provider.

Published August 23, 2021

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Get in touch with the Corner crew at pcc@affygility.com.