Compliance Audit - GMP & cGMP
Good Manufacturing Practices (GMP)
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 standards. 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.