Reserve Samples Requirements in 3 Simple Steps

The Problem

Reserve sample requirements are specific and strictly enforced. FDA regulations dictate exact retention times and storage conditions for active ingredients and finished products. Getting this wrong can lead to observations and inability to investigate future complaints.

Example: You have an active ingredient lot expiring soon. Do you know exactly how long you must retain the reserve sample after the expiration date of the last product batch made from it?

Here's how KeyPedia helps you manage sample retention: just ask KeyPedia to cite the specific reserve sample requirements for your material type.

Why? Because KeyPedia's input is fed from guidance documents, FDA regulations, good practices, FDA-483s, and Warning Letters.

1. Ask

Ask KeyPedia: "What products and materials require the preservation of reserve samples and for how long?"

2. Review

KeyPedia breaks down 21 CFR 211.170, detailing requirements for active ingredients (1 year after product expiration) and drug products.

3. Implement

Update your sample retention schedules to ensure full compliance with regulatory timelines.

From retention confusion to regulatory certainty, see how KeyPedia helps you manage your sample inventory:

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