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GLP & cGMP Testing

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 9001:2008 certification systems. In order to ensure 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 back up of all electronic administrative and laboratory data. All instruments are formally qualified to ensure they are operating as expected. Instruments are also regularly calibrated with certified standards, and periodically re-qualified to ensure on-going 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 .

 

 

Current Good Manufacturing Practices (cGMP)

 

Impact Analytical has significant experience in the performance analytical testing to support the regulatory requirements for drug 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 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 9001:2008 certification systems. In order to ensure compliance to the cGMP standards and to assure data integrity, 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 back up of all electronic administrative and laboratory data. All instruments are formally qualified to ensure they are operating as expected. Instruments are also regularly calibrated with USP or other certified standards, and periodically re-qualified to ensure on-going reliability. All compliance systems and processes, and all cGMP study data are audited by an independent Quality Assurance Unit to assure compliance to the 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.

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