Quality Assurance Program

Galbraith maintains a comprehensive Quality Assurance Program, supported by a full-time manager and staff. The Quality Assurance Department monitors all analyses to ensure that methods, practices, records, and controls are in conformance with client-designated regulatory requirements, as well as Galbraith’s own internal standards. Our Quality Assurance Program complies with applicable laboratory requirements defined in 21CFR58, 40CFR160, 40CFR792, and 21CFR211.

Galbraith routinely provides analyses in accordance with GLP (Good Laboratory Practices), cGMP (Current Good Manufacturing Practices), FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act), and other regulations. Galbraith is registered with the Food and Drug Administration as a drug establishment. Beyond basic regulations, Galbraith’s work is supported by a system of controls, validation, inspections, and audits: in-house and for our vendor/supplier program. In addition, Galbraith undergoes routine auditing by clients as a support facility for EPA, FDA, and NRC regulated studies.

Whenever possible, our analytical services are performed according to methods approved by the U.S. Environmental Protection Agency (EPA), the Association of Official Analytical Chemists (AOAC), the American Society of Testing and Materials (ASTM), and other recognized organizations. Galbraith has specific experience in performing analyses according to any Compendial method suitable for the analyses performed by the Laboratory.

Overview

GLI routinely performs laboratory analyses in accordance with such standards as Good Laboratory Practices (FIFRA, TSCA, non-clinical studies), Current Good Manufacturing Practices (pharmaceuticals, medical devices), and EPA. Because of the great variety and broad applicability of our methodologies, we do require prior written notification of regulated sample submissions and recommend a thorough discussion of the project with our technical staff.

There are three levels of Quality Assurance to support Galbraith’s analytical services, as noted below.

QA Basic

This service level covers general testing, low-risk analysis, and non-regulatory analyses with a low impact failure outcome for industry or academia. General testing, screening tests, research and industrial use are appropriate for this level. QA Basic does not include focused or redundant inspections or performance audits. Peer and technical management data review supports final report accuracy. A written SOP or protocol is not required.

The cost for this service is included in basic sample overhead and charges.

QA Regulatory

This service level is recommended for pervasively regulated industries with conformance to FDA, EPA GLPs, cGMPs, or Nuclear Quality Systems where the failure outcome is individual fatality, widespread serious injury, or large financial risk. Other clients who support the preceding industries could also use this service. QA Regulatory includes all the features of QA Intermediate; fulfillment of regulatory requirements; 100% inspection of final reports against raw data for conformance to regulatory guidelines; random in-process performance audits to supplement systems audit; and sampling inspection of logs from QA Regulatory submission pool within two weeks of the report. A GLP or cGMP Compliance Statement is included, but the transfer of QA audit and inspection reports, and QA Statements are not included.

All samples submitted under QA Regulatory will have a 60% surcharge.

QA Custom

This service level is recommended for clients with corporate systems of their own design who wish to have that specific system followed in aspects appropriate to laboratory work; overlap of multiple quality system requirements; QA Regulatory clients desiring in-process audits on a specific sample or sample series; QA Regulatory clients requiring a validated, non-Compendial method not currently in use on their matrix; areas of highest financial risk; failure outcomes of widespread fatality or serious injury.

QA Custom features incorporation of specifically stated aspects of the Galbraith Quality System; review of client corporate quality system for appropriate additional steps to the Galbraith Quality System; modification to procedures in use to meet client specifications; allowance for client observation of analysis in progress; narrative report of changes incorporated and observations on conformance to the modified quality system; and documented prior incoming materials test on reagents used. A GLP QA Statement and copies of QA inspection and in-process audit reports are included. All samples submitted at this level will be subject to custom charges starting at a baseline of 60% surcharge for a QA Statement and copies of inspection reports. Additional services add to the base cost and are determined on a custom charge per service. Costs are based on laboratory resources involved in carrying out the service.