As a company, you want to ensure that you are following all regulations to keep your business running smoothly. For any of your regulation questions or concerns, MEIRxRS has experienced auditors who can help through a comprehensive audit, audit consulting and audit preparation.
GCP Auditors provide third-party verification that good clinical practices (GCP) are followed. GCP is an international quality standard that is provided by the International Conference on Harmonisation (ICH). It ensures that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. GCP guidelines include protection of human rights in order to protect subjects and volunteers in a clinical trial.
GLP Auditors provide third-party verification to ensure that good laboratory practices (GLP) are followed. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment. It ensures that safe, effective, and high-quality products are developed and registered in the most resource-efficient manner.
GMP Auditors differ from GCP auditors, as they provide third-party verification that good manufacturing practices (GMP) are followed. These practices ensure that products are manufactured consistently and to an expected level of quality. They’re also required in order to conform to regulatory agency-recommended guidelines. Agencies such as the FDA control authorization and licensing for the manufacture and sale of food, pharmaceutical, nutraceutical, cosmeceutical and medical devices. GMP guidelines provide minimum requirements that a manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Pharmacovigilance Auditors provide third-party verification that your systems and documentation are in place and consistently followed. This ensures drug safety, protects your patients and meets regulatory requirements. Third-party audits also provide an opportunity to uncover issues in advance of formal regulatory inspections, which can lead to warning letters and a potential halt in productivity.
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