Date: October 6, 2026
FDA’s Bioresearch Monitoring compliance program 7348.808, Good Laboratory Practice (Nonclinical Laboratories), now carries an implementation date of October 6, 2026. The change history describes the update as a partial revision of Part III, Section 2 only, to align with OECD reporting requirements. An earlier partial revision, dated May 20, 2025, was made to include in vivo and in vitro practices. The program directs FDA investigators conducting GLP inspections and data audits under 21 CFR Part 58.
Revised Section 2, Areas of Expertise and Product Types for OECD Reporting, explains that FDA, as a member of the OECD Working Party on Good Laboratory Practice, regularly submits lists of inspections that include information from establishment inspection reports (EIRs). It asks FDA investigators to record the facility’s study types, such as “Analytical and clinical chemistry testing,” and the product types it tests, including those outside FDA jurisdiction, in the History of Business section of the EIR.
The May 20, 2025 revision also updated OII reorganization information and made minor administrative corrections. Part III, Section 4.D (Final Report vs. Raw Data) gives separate examples of data to check for in vivo studies and for in vitro studies. The change history does not say which passages the May 2025 revision changed.
What it means for calibration
The October revision did not change the provisions on equipment, computer systems or data audits described here. The equipment review (Part III, Section 3.D, covering 21 CFR 58.61 to 58.63) has FDA investigators check, for representative pieces of equipment, the “Standardization/calibration procedure, schedule, and log.” That follows 21 CFR 58.63, under which equipment used to generate, measure or assess data “shall be adequately tested, calibrated and/or standardized,” with SOPs that set out methods, materials and schedules, and written records of each calibrating and standardizing operation. In the data audit (Part III, 4.B.ii), FDA investigators determine whether the equipment used was standardized and calibrated before, during and after use in the study, so in practice each study’s analytical runs should trace to the equipment calibration records that cover them. For in vitro studies, the Section 4.D examples include “Maintenance, calibration, and validation records for incubators and pipettors.”
For computer systems (Part III, 3.D.ii.f), FDA investigators assess whether procedures exist for validation, for control of changes and for evaluation of test data “to assure that data are accurately transmitted and handled properly when analytical equipment is directly interfaced to the computer.” They also determine whether SOPs ensure data quality and integrity, including “an audit trail covering all data changes” (3.E.ii.f). For calibration data, the practical implication is validated transfer from the instrument to the processing software and a reviewable record of every change to a curve.
Also see: fda.gov, Bioresearch Monitoring Program (BIMO) compliance programs; govinfo.gov, 21 CFR 58.63, Maintenance and calibration of equipment (2025 edition)
Part of the WLTR ICH M10 guide for pharmaceutical and bioanalytical labs. This is a plain-language summary, not regulatory advice. Confirm requirements with the issuing agency and your quality unit. Questions or a different read on this change? Leave a comment below.