Quality Assurance Overview
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 21CFR 210, 211 and 820.
Galbraith provides analyses in accordance with GLP (Good Laboratory Practices), cGMP (current Good Manufacturing Practices), FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act), NRC (Nuclear Regulatory Commission) and other regulations. Because of the 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.
Galbraith is registered with the Food and Drug Administration and is routinely inspected as part of that registration. Galbraith also hosts client audits as a support facility for EPA, FDA, and NRC regulated studies. Please contact our Quality Assurance team to schedule an audit.
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. Extensive method development and method validation services are available to assist with compliance to regulatory requirements. Galbraith has specific experience in performing analyses according to any Compendial method suitable for the analyses performed by the Laboratory.
The Quality Assurance Manager is responsible for maintaining a quality system that is compliant with the regulations listed above. This system includes programs for internal audits, CAPAs, Customer Complaints, QA Inspection, Archival of raw data, training, equipment validation, method validation and other areas to ensure compliance with the regulations. There are two levels of Quality Assurance to support Galbraith’s analytical services, QA Basic and QA Regulatory.
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 development 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. Routine quality control and system suitability requirements are incorporated into this program.
There is no additional expense for this level of oversight.
This service level is recommended for regulated industries that require 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 provide product to these industries may also use this service. In summary, QA Regulatory inspections include 100% inspection of final reports against raw data for conformance to regulatory guidelines, random in-process performance audits to supplement systems audit, and inspection of all raw data generated in support of a GMP, GLP or NRC reports. Additionally, all regulatory samples require project manager oversight by a qualified technical manager. A GLP or cGMP Compliance Statement is included in the final report.
All samples submitted under QA Regulatory will carry a 65% surcharge.