GLP - Good Laboratory Practice
Good Laboratory Practice (GLP) describes how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported, and archived as set forth by the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA), as well as the Organization for Economic Co-operation and Development (OECD) international guidelines. Adherence to the GLP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. GLP certification includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories
Significance of GLP certification
*The importance of GLPs, the FDA designs GLP regulations to “assure quality is built into the design and manufacturing process at every step.” The consumer has to trust that federally regulated products are safe
Benefits of GLP certification
*Operating costs is very low and avoid penalties. *Maintain a Green Process to deliver Product or Service provision, *Provide a Green System towards a Sustainable Business.
Certification process
- Complete a profiling form to customize a quote for your organization detailing the cost, planning and time required.
- Conduct a pre-audit to determine if your organization already fulfills the requirements for GLP and identify areas for improvement.
- Stage 1 site visit by our auditors to verify the profile submitted during your application and determine your readiness for Stage 2.
- Stage 2 on-site audit by MOODY auditors.
- Propose and implement corrective actions, if any. *Receive your audit report and certificate from committee.
Why choose MOODY?
MOODY is a global leader in management systems solutions, having issued various management systems certifications to date. Our dedicated and experienced auditors across the globe can speak your language and help you explore the possibility of integrating your GLP certification initiative with other management systems. We can also act as a one-stop provider for all your quality certification needs by offering bundled product testing and certification services. With the MOODY certification mark, you demonstrate your commitment to delivering quality products and services.