CANNY accepts domestic and foreign customers to conduct GMP audits on Chinese API/drug suppliers and evaluate suppliers' GMP compliance, or conduct GMP simulation audits of pharmaceutical factories before foreign official GMP on-site inspections, or accompany foreign official GMP on-site inspections.
1.Commercial audit and certification
The service is commissioned by the US/EU/WHO purchaser to conduct a GMP audit of Chinese APIs or drug suppliers and to evaluate the supplier's GMP compliance, providing more protection and success for buyers in China's procurement success.
The service program is as follows:
(1) Prepare the GMP audit check outline, that is, according to the requirements of the entrusted client, develop audit guidelines and rules for the actual situation of the supplier according to ICH Q7 or other applicable GMP guidelines;
(2) Conduct on-site inspection and audit, that is, conduct a two-day on-site inspection, audit and interview with the supplier, covering all aspects of the GMP six major systems involved in the FDA;
(3) Prepare a detailed audit report, which is to prepare a professional detailed audit report for the entrusted client, classify and interpret the GMP defects observed at the site, and provide GMP basis for the decision of the entrusted client;
(4) Sending a GMP defect letter to the supplier, sending a GMP defect letter to the supplier and discussing with the supplier how to take corrective actions against the relevant GMP defects and prevent recurrence measures;
(5) Monitor the supplier defect improvement and improvement exhibition, that is, monitor the status and progress of the supplier's rectification of GMP defects, and conduct on-site visits to suppliers to confirm the implementation of the rectification of defects;
(6) If necessary, carry out on-site GMP special training, that is, provide targeted GMP on-site training to suppliers according to GMP defects, and improve supplier's understanding and implementation level of GMP.
The service is commissioned by domestic and foreign customers to conduct GMP simulation audits of pharmaceutical companies prior to on-site inspections in the US/EU/WHO official GMP, to identify GMP defects for customers and to provide a US/EU/WHO GMP-compliant and practical rectification plan. Promote customers to rectify GMP defects and eliminate GMP hazards in the short term, and effectively improve the success rate of customers passing the US/EU/WHO official GMP on-site inspection.
Kanglihua provides domestic customers with simulated audit services to improve their US/EU/WHO GMP implementation level. After the audit, they will provide Chinese and English audit reports and defect analysis for pharmaceutical companies. The GMP status report after defect rectification can be used as an important reference. The information is provided to foreign buyers or contractors, providing GMP evaluation opinions and guarantees for pharmaceutical companies in the manufacture of pharmaceutical contracts and the export of preparations.
The service procedures are as follows: prepare simulation audit inspection guide according to customer requirements; conduct on-site audit (including on-site observation, dialogue, discussion, discussion, risk analysis and negotiation solution for defects); prepare audit report, issue GMP defect letter, monitor defect rectification Progress; Prepare an overall evaluation report on the implementation level of Chinese and English GMP.
Many US and European pharmaceutical companies invite independent consulting firms to conduct simulation audits (internal audits) each year. The purpose of this is to find out the problems that buyers can't find in commercial audits, and provide risk analysis and feasible rectification solutions for these problems.
3. Official escort inspection
The service is commissioned by domestic and foreign customers to accompany the US/EU/WHO inspectors to conduct an official GMP on-site inspection of the pharmaceutical factory to improve the success rate of customers passing the US/EU/WHO official GMP on-site inspection.
The service procedures are as follows: accompany the official inspection according to the customer's request, serve as the on-site professional translation work; help the pharmaceutical company to reply to the official inspection defect letter (if necessary).