Federal Regulatory Support:
Compliance Audit - GMP & GLP

Good Manufacturing Practices (GMP) &
Current Good Manufacturing Practices (cGMP)

GMP compliance is required by OECD countries and cGMP is required by the U.S. FDA to ensure that proper guidelines are followed in the manufacturing of active pharmaceutical ingredients (APIs), finished drug formulations,

animal drugs

, dietary supplements,

food and food additives

 and

medical devices

.
 
TSG assists in the following aspects of GMP/cGMP compliance:

Manufacture Audit

– Based on the needs of the client, TSG will visit a manufacturer’s facility and meet with the company’s technical representatives to review existing GMP or cGMP documentation and the manufacturer’s current compliance with these requirements. TSG will then provide a written auditing report to the clients.

Assisting Manufacturers to Establish GMP/cGMP Compliance

– Based on the needs of the client, TSG will conduct a facility evaluation (materials and process documentation, quality control, stability testing, product and label control) and review existing Standard Operating Procedures (SOPs) for compliance with international Inspection of manufacturing facility for Good Manufacturing Practice, GMP, compliancestandards. TSG will then identify additional SOPs subject to compliance, assist in writing additional SOPs and conduct onsite GMP/cGMP orientation and

training

for the facility. TSG will follow up with detailed documentation on the facility, proceed to establish quality control mechanisms and oversee the completion of documents and GMP/cGMP program requirements.

After this process is completed, TSG will conduct a facility audit to ensure GMP/cGMP compliance. This includes a production line and facility inspection, laboratory inspection, raw data audit and QA documentation audit. TSG will finalize the audit by preparing a report and discussing the findings with the company’s technical representatives and management.

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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