Microchem Regulatory Compliance Snapshot: ISO 17025, GMP & GLP

Microchem Laboratory’s regulatory compliance is built on an ISO 17025 accredited quality system including GMP and/or GLP compliance depending on the client’s regulatory needs.

ISO 17025’s requirements cover a lab’s technical capabilities in addition to the basics found in the ISO 9001 quality standard.

Microchem’s quality policy manual outlines the basic requirements of the internationally recognized standard:

• Impartiality & confidentiality
• Personnel education & training
• Equipment qualification
• Selection, verification, and validation of methods
• Ensuring validity of results
• Reporting of results
• Complaints
• Internal audits and continuous improvement

With accreditation to the ISO 17025 standard, you can be confident that the laboratory testing performed at Microchem Laboratory meets the highest technical and quality principles in the industry.

Good Manufacturing Practices (GMP) regulations apply to final products, with a focus on proving that a manufactured product meets predetermined specifications. Clients choose Microchem’s GMP testing when looking to ensure each batch of their product adheres to requirements for lot release. With the foundations of an accredited ISO 17025 laboratory, the GMPs introduce an independent quality control unit which has the authority to approve or reject procedures, materials, and results.

Under the GMP framework for pharmaceuticals, dietary supplements, and medical devices set in 21 CFR 211 and 21 CFR 820, procedures are standardized to ensure consistency of the product. In this capacity, Microchem acts in a quality control capacity, ensuring test results are consistent and accurate. Out of specification findings are investigated by the quality control unit.

Good Laboratory Practices (GLP) regulations apply to pre-clinical product development and other non-clinical testing, with a focus on proving safety and/or efficacy. GLP testing is typically conducted to support FDA pre-market approval or EPA pesticide registration and associated marketing claims. Clients choose GLP testing when looking to enhance the regulatory acceptability of open-ended studies. With the foundations of an accredited ISO 17025 laboratory, the GLPs include an independent quality assurance unit which performs audits of active testing and review of the final report to ensure authenticity of the data submitted to the regulatory agency. Microchem’s GLP quality assurance unit includes RQAP-GLP certified auditors.

Under the GLP framework outlined in 21 CFR 58 and 40 CFR 160, procedures are approved by Testing Facility Management (TFM). A study is assigned to a Study Director by the designated TFM. The Study Director takes responsibility for all aspects of the study and interpretation of the data. A signed protocol serves as a contract between the client (sponsor) and Microchem outlining desired testing parameters. Changes from this protocol, impact to testing, and corrective actions taken are outlined in the final report.

Contact Microchem Laboratory to discuss your testing needs today: [email protected].