Lab Space & Inventory Management

Guides

cGMP Facility Requirements: Design, Zoning, and Qualification

What a facility must have to meet FDA and international cGMP standards: the 21 CFR 211 Subpart C basis, core design elements, cleanroom classification, and the IQ/OQ/PQ qualification process.

ISBT 128: The Global Labeling Standard for Blood and Tissue Products

ISBT 128 is the global labeling standard for blood, tissue, and cellular therapy products, maintained by ICCBBA. Here’s how its barcode and identification structure works, and where it’s required.

Asset Disposal Policy for Lab Equipment: What to Include

What a lab or institutional asset disposal policy needs to cover: scope, approval authority, disposal methods, documentation, and how it must align with 2 CFR 200.313 for federally-funded equipment.

Laboratory Asset Management Software: What It Does and How to Choose It

What laboratory asset management software actually does, how it differs from LIMS/ELN/chemical inventory systems, the features worth evaluating, and why 2 CFR 200.313 makes it especially useful for federally funded labs.

Capitalization Threshold for Research Equipment: Setting Your Institution’s Policy

A capitalization threshold is the dollar line between expensing and capitalizing a purchase. This guide explains how research institutions set their own threshold, how it interacts with the 2 CFR 200.1 federal equipment floor, and how both differ from the GAAP and IRS capitalization thresholds that dominate generic search results.

DEA Researcher Registration: Form 225, Schedule I Approval, and Timeline

How to register with the DEA to conduct Schedule I-V research: which form applies, what a Schedule I protocol must include, what the field-office review checks, and how long it realistically takes.

CDC Vaccine Storage and Handling Toolkit: A Practical Implementation Guide

A practical, operational walkthrough of the CDC Vaccine Storage and Handling Toolkit: storage equipment, temperature ranges, monitoring, inventory management, SOP requirements, and transport rules for clinics, pharmacies, and research vaccine programs.

Controlled Substance Inventory: DEA Biennial Requirements for Research Labs

What DEA-registered research labs must record in an initial and biennial controlled substance inventory under 21 CFR 1304.11, including exact vs. estimated counts, log templates, retention periods, and discrepancy reporting.

Shelf-Life Extension Program (SLEP): What It Is and What Actually Applies to Your Lab

SLEP is the federal DoD/FDA program that extends shelf life on stockpiled drugs and materiel — but most labs actually need FDA-authorized, manufacturer-published lot extensions instead. Here is how each mechanism works and how to check your own lot.

Lab Freezer Inventory Systems: Tracking Biological Samples in Cold Storage

A practical guide to organizing lab freezer inventory across -20C, -80C, and liquid-nitrogen storage tiers: freezer mapping, inventory software features, barcode identifiers, and backup power/alarm planning.

Sample Chain of Custody in Research Labs: What It Is and How to Document It

What sample chain of custody means in a research lab, when it is actually required (CLIA/CAP, sponsor agreements, controlled substances, IP disputes), what a complete custody record must document, and how to build a process that avoids common gaps.

Lab Equipment Disposition When a Lab Closes: Surplus, Transfer, or Disposal

When a lab closes, every instrument needs a documented destination: surplus, transfer, or disposal. This guide covers classifying equipment by funding source, the 2 CFR 200.313 disposition thresholds for federally funded equipment, government-furnished property rules, required decontamination, and documentation.