EPA or FDA-regulated products and processes require regulated testing to prove they are safe, reliable, and efficacious.
The regulations that cover lab testing are generally either Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), or Good Manufacturing Practices (GMPs).
Quality regulations in general are often referred to as the GxPs, where the “x” denotes the applicable “Good Practice” standard. Quality assurance systems make GxP compliance possible.
Good Manufacturing Practices (GMP) ensure drugs and medical devices are safe for public use. Good Clinical Practices (GCP) regulate trials of drugs and medical devices on human subjects. Good Laboratory Practices (GLP) apply to non-clinical tests of drugs, devices, and antimicrobial pesticides (disinfectants) that are intended to support applications for research or marketing permits from the EPA or FDA.
EPA and FDA ensure compliance with GxPs by auditing labs to ensure the integrity of data, products, and the safety of clinical study subjects. Cosmetic products are not federally required to be tested in accordance with GLP, GCP, or GMP standards. However, most cosmetic companies incorporate critical elements of these standards into testing and production for consumer safety and marketing purposes.
Microchem Laboratory is a GLP-compliant test facility, conducting open-ended efficacy studies across a wide array of antimicrobial products. For an active GLP study, our Quality Assurance Team’s primary responsibility is to assure test facility management that studies conform to the Good Laboratory Practice regulations found at either 40 CFR 160 (EPA GLPs) and 21 CFR 58 (FDA GLPs), depending on the product type under study. This includes verifying that the agreed-upon test protocol was followed and the data was recorded and reported accurately, and that it reflects the observed results.
Microchem’s quality assurance unit is independent from the conduct of any GLP study and reports to management separately from the scientific staff. This preserves its independence and objectivity. In addition, Microchem’s quality team audits the facility on a rolling basis across dozens of areas ranging from equipment calibrations to the labeling and storage of test substances.
For more information on GLP and Quality Assurance or product regulations, contact our lab at [email protected].