GLP & cGMP
Good Laboratory Practices (GLP)
Impact Analytical has significant experience in the performance analytical testing to support product registrations for the US FDA, US EPA and OECD regulatory agencies. Specifically, we can perform studies which fully comply with the following Good Laboratory Practice standards: 21 CFR Part 58 (“FDA GLPs”), 40 CFR Part 160 (“EPA GLPs”) and ENV/MC/CHEM(98) 17 (“OECD GLPs”).
Impact Analytical has performed numerous studies including method validation studies, test and reference material characterizations, dosing concentration confirmations, stability studies and physical property testing under these standards.
Impact Analytical developed a fully compliant quality system which enhances our ISO 9001:2015 certification systems. In order to guarantee compliance to the GLP standards, we added a number of additional practices and processes. These include a validated document management system which maintains a historical archive of all SOPs, formalized compliance training and records, and secure data archives as well as backup of all electronic administrative and laboratory data. All instruments are formally qualified to establish that they are operating as expected. Instruments are also regularly calibrated with certified standards, and periodically re-qualified to ensure ongoing reliability. All compliance systems and processes, and all GLP study data are audited by an independent Quality Assurance Unit to assure compliance to the applicable GLP standards.
Impact Analytical has been successfully audited against the GLP standards by numerous customers and by the EPA and FDA.
Current Good Manufacturing Practice (cGMP)
Impact Analytical has significant experience in the performance analytical testing to support the regulatory requirements for drug and device products, packaging and production processes as required by the US FDA Current Good Manufacturing Practices (21 CFR Parts 210 and 211).
Impact Analytical has performed numerous studies, including method development and validation studies; drug and device testing using validated or USP/NF or EP methods; dissolution testing, stability testing, and leachables and extractables testing. We have also conducted troubleshooting and failure analyses to provide production support for our customers.
Impact Analytical developed a fully compliant quality system built upon on our ISO 9001:2015 certification systems. We added a number of additional practices and processes to ensure compliance with cGMP standards and data integrity. Among these are a validated document management system that keeps a historical archive of all SOPs, formalized compliance training and records, secure data archives, and backup of all electronic administrative and laboratory data. All instruments are formally qualified to ensure they function properly. Instruments are also calibrated on a regular basis using USP or other certified standards, and they are re-qualified on a regular basis to ensure ongoing reliability. An independent Quality Assurance Unit audits all compliance systems and processes, as well as all cGMP study data, to ensure compliance with cGMP standards.
Impact Analytical has been successfully audited against the cGMP standards by numerous customers and by the FDA. Please contact us if you would like to schedule an audit.
Whitepaper: Adding Value by Integrating cGMP with an ISO 9000 Quality Management System
By: John MacLauchlan, Quality Systems, Impact Analytical
Case Study Industry: Pharmaceutical
Problem: Stabiliy Sample Testing Support under cGMP
Solution: Validated Method – read full case study
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