Manufacturing Made Simple Podcast
Aug 5, 2026 · 25 min · 8 segments
The regulatory arc generates the highest question volume of any topic in the series. Andrew answers listener questions on MoCRA timelines, EU registration, the sunscreen monograph situation, OTC…
Andrew CheungHost
We're a small personal care manufacturer, about 12 employees, three production lines.
What should we actually be doing right now? Well, first, the panic is understandable, but it's not also fully warranted.
MOCRA has phased compliance timelines, and honestly, small businesses, you know, defined by the regulation by specific annual revenue thresholds, have modified requirements and extended timelines for some provisions.
So the first thing that I'd do is verify which tier of the regulation applies to your operation based on your revenue.
Now that said, here are the three things I prioritize regardless of the size of your company.
If you haven't registered your facility with the FDA, that's the most time-sensitive obligation.
Who receives the adverse event reports when they come in through customer service or social media, how they get escalated, what documents need to be created, and who is responsible for the 15 business day FDA reporting decision? Write that procedure, train your customer-facing people on it, and document that you did.
We don't have a final rule yet, but we know it's coming and we know the direction it's heading.
Do an honest gap assessment against pharmaceutical grade GMP principles, written procedures for critical manufacturing steps, batch records, out of spec investigation processes, that sort of thing, and start closing the gaps that you find.
Every month that you spend building towards that standard before it's required is a month that you're not scrambling after this.
Small manufacturer, 12 employees, three production lines, that's actually a very manageable compliance footprint.
We're a small personal care manufacturer, about 12 employees, three production lines.
What should we actually be doing right now? Well, first, the panic is understandable, but it's not also fully warranted.
MOCRA has phased compliance timelines, and honestly, small businesses, you know, defined by the regulation by specific annual revenue thresholds, have modified requirements and extended timelines for some provisions.
So the first thing that I'd do is verify which tier of the regulation applies to your operation based on your revenue.
Now that said, here are the three things I prioritize regardless of the size of your company.
If you haven't registered your facility with the FDA, that's the most time-sensitive obligation.
Who receives the adverse event reports when they come in through customer service or social media, how they get escalated, what documents need to be created, and who is responsible for the 15 business day FDA reporting decision? Write that procedure, train your customer-facing people on it, and document that you did.
We don't have a final rule yet, but we know it's coming and we know the direction it's heading.
Do an honest gap assessment against pharmaceutical grade GMP principles, written procedures for critical manufacturing steps, batch records, out of spec investigation processes, that sort of thing, and start closing the gaps that you find.
Every month that you spend building towards that standard before it's required is a month that you're not scrambling after this.
Small manufacturer, 12 employees, three production lines, that's actually a very manageable compliance footprint.
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