GLP for analytical labs

Analytical labs feel GLP at the bench: every pipette calibration, every chromatography audit trail, every sample login. This is the lab-level implementation guide.

Start with the SOP system

GLP lives or dies on SOPs that match actual bench practice. Inventory every routine operation, write or rewrite SOPs to describe what really happens, get them approved, and train to them. Stale SOPs that nobody follows are the single most common inspection finding category.

Equipment qualification is non-negotiable

Every instrument generating regulated data needs qualification, calibration, and maintenance records — current, complete, and retrievable. Backfill the history where you can; where you can't, document the gap and the fix going forward.

Data integrity and Part 11

Computerized systems need audit trails, controlled access (no shared logins), and validated spreadsheets or — better — validated chromatography data systems. If your lab still runs critical calculations in uncontrolled Excel, fix that before anything else: data integrity is where inspections live or die.

Samples, archives, QA

Chain of custody from receipt to disposition; a secure archive for raw data and reports; and a QA function with real independence — even if it's one person part-time, or a contracted QA professional. Small labs commonly use consultants for the QA role while building internal capability.

What it costs and how long

A lab-level GLP build typically runs 6–12 months from a reasonable baseline. Budget using the estimator (audit days × published day-rate benchmarks + training), remember internal staff time dominates (52% in a documented case), and get scoped quotes from lab-focused firms.