Federal Regulatory Support:
Compliance Audit - GLP

Good Laboratory Practices (GLP)

GLP compliance is required for studies submitted in support of product approvals with

pesticides

,

new chemicals

and petitions to establish

maximum residue levels (MRLs)

for EPA, PMRA and the EU, as well as pharmaceuticals,

animal drugs

and medical devices for FDA and the EU.

TSG assists in the following aspects of GLP compliance:

Laboratory Audit

– Based on the needs of the client, TSG will visit a laboratory facility and meet with the technical, management and quality assurance personnel to review existing GLP documentation and the current compliance with the GLP requirements. TSG will then provide a written auditing report to the client.

Assisting Laboratories to Establish GLP Compliance

–  Based on the needs of the client, TSG will conduct a laboratory evaluation (personnel training and records, materials and experimental or analytical documentation, quality assurance and more) and review existing SOPs for compliance with international standards. TSG will then identify additional SOPs subject to compliance, assist in writing additional SOPs and conduct onsite GLP orientation and training for the facility. TSG will follow Inspection of laboratory for Good Laboratory Practices, GLP, complianceup with detailed documentation on the facility, proceed to establish Quality Assurance (QA) mechanisms and oversee the completion of documents and GLP program requirements.

After this process is completed, TSG will conduct a laboratory facility audit to ensure GLP compliance. This includes inspection of all relevant laboratories and facilities, inspection of sample collection, preparation and storage procedures, inspection of analytical procedure and raw data audit, as well as a QA documentation audit. TSG will finalize the audit by preparing a report to discuss the findings with laboratory technical representatives, management staff and QA unit.
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