How Strategic Planning for OEL/ADE reports in Pharmaceutical Manufacturing Facilities Can Save You Money in the Long Run

I'm about to tell you a story—a tale of horror that may make you clutch your emotional support blanket a little tighter. This is the story of a quality person who neglected to purchase the essential Occupational Exposure limits (OEL) and Acceptable Daily Exposure (ADE) documentation for the products in their pharmaceutical manufacturing facilities.

Maybe they thought they could skip the hassle, or perhaps they wanted to avoid the cost. Everything seemed to be going smoothly... until one day, they received dreadful news: a regulatory audit was coming.

Panic set in. Desperate to find the OEL/ADE reports they needed; the quality person scrambled to buy everything at once. This last-minute purchase spree cost them thousands of dollars—a hefty price for poor planning. Sadly, this is not just a tale; it’s a true story, and it's all too common.

Poor planning can lead to costly mistakes: unnecessarily bulk buying OEL/ADE reports, duplicating purchases, or paying rush fees to meet urgent deadlines. The reality is simple: when it comes to acquiring OEL/ADE reports, poor planning comes at a high cost.

What is an OEL

Occupational exposure limits (OELs) are defined as the time-weighted average concentration of a contaminant, measured in the employee’s breathing zone, that is considered to be safe for the majority of healthy workers, for an eight-hour work shift and a forty-hour work week, and an entire working lifetime. OELs are health-based values that are established by expert toxicologists reviewing existing published, peer-reviewed literature, and scientific databases. The establishment of occupational exposure limits are critical for protecting the health of workers in the pharmaceutical industry. OELs assist in defining the containment performance target of the engineering controls needed in a unit operation. The importance of having an OEL is not just having the number, but it is ensuring that your containment is effective at preventing occupational illness and reducing the probability of having cross-product contamination.

What is an ADE?

An acceptable daily exposure limit (ADE), is the daily dose of a substance which no adverse events are anticipated, even if exposure occurs for a lifetime. ADEs are used in maximum amount of carry-over (MACO) equations in order to prevent cross-product contamination.

Cross product contamination occurs when trace amounts of one product unintentionally mix with another during the manufacturing, packaging, or storage processes. Cross-contamination is particularly concerning in facilities that produce multiple drugs or substances. Cross-contamination undermines the safety, efficacy, and quality of the affected product. Regulatory agencies have strict requirements to prevent cross-contamination. Failing to meet these standards can result in fines, recalls, or disruptions of pharmaceutical manufacturing facilities.

What is a PDE?

The term permitted daily exposure?(PDE), was first defined in the European Medicines Agency ?Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.

Are PDE and ADE the same?

In short? Yes, they are.

While the calculation variables provided by the?European Medicines Agency (EMA)?health-based exposure limit guidance differs from those provided by the International Society of Pharmaceutical Engineers (ISPE)?Risk-MaPP document, as indicated in the EMA Guidance, the terms are effectively synonymous (meaning that the result will be the same).

Acceptable daily exposure (ADE) and permitted daily exposure (PDE) are exposure limits, by any route (including inhalation, ingestion, dermal, ocular, and injection), for preventing adverse health effects in the patient population due to cross-product contamination.

ADEs/PDEs?must NOT?be confused with occupational exposure limits (OELs) or occupational exposure bands (OEBs) that are exposure limits for preventing adverse health effects for workers.

Audits and the importance of an audit

Regulatory audits help pharmaceutical manufacturing companies achieve safety standards, minimize risks, and ensure consistent regulatory compliance. This contributes to the overall success and safety of the pharmaceutical and chemical industries.

These inspections help prevent issues such as defective products, costly recalls, or legal liabilities while reinforcing consumer trust in the company’s commitment to high standards.

Importance of OEL/ADE/PDE

The OEL/ADE/PDE is crucial for pharmaceutical manufacturing facilities because it helps ensure that the personnel working with potentially hazardous substances are not exposed to levels that could cause adverse health effects. These limits are vital for creating a safe environment within pharmaceutical manufacturing facilities by helping to manage exposure risks, safeguard health, and comply with regulatory standards.

Regulatory Agencies

Regulatory agencies such as the EMA (European Medicines Agency), PIC/S (Pharmaceutical Inspection Co-operation Scheme), ANVISA (Brazilian Health Regulatory Agency), and WHO HBEL (World Health Organization's Health-Based Exposure Limits guidelines) play a critical role in the toxicology and pharmaceutical industries. These organizations establish frameworks, guidelines, and standards to ensure the safety, efficacy, and quality of medicines and chemical products.

Information included in an OEL Monograph

The following information is included on each OEL monograph: generic name, numerical occupational exposure limit, control banding classification based on Affygility Solutions' 5-band scheme, C.A.S. number, structure, basis for classification, therapeutic indication, mechanism of action, efficacy and dose, toxicology summary, carcinogenic, reproductive and developmental hazards, OEL calculations with the uncertainty and modifying factors used, indication whether an industrial hygiene method is available, and references.

Affygility Solutions and OEL Fastrac+

Since 2002, Affygility Solutions has provided potent compound safety, occupational toxicology, and industrial hygiene services to life science companies worldwide. With decades of pharmaceutical industry experience, our team holds prestigious certifications, including DABT, ERT, and CIH.

With an OEL Fastrac+ subscription, planning which products you will bring into your pharmaceutical manufacturing facility as well as planning for a regulatory audit becomes easier. Gain access to a comprehensive library of all your downloaded reports, allowing you to track what you already have and plan for future needs. You’ll also have visibility of all OEL/ADE values in the catalog, enabling quick decisions on product handling, saving you both time and money. ?When you're ready to move forward with a project, you can download the necessary report into your library, avoiding last-minute delays.

Proactive planning with OEL Fastrac+ helps ensure workplace safety and operational efficiency. Contact Peter Burke or Joanne Low for a free demo and discover how OEL Fastrac+ can streamline your workflow.