Compliance First, Recording Innovation & Development

In early September, the quality, regulatory and supply chain teams of a domestic partner Marketing Authorization Holder (MAH) visited the company for a one-day on-site quality audit.

The audit covered facilities, production processes, the quality control laboratory, raw material and finished goods warehousing, transportation and the documentation system. The auditors sampled batch production records, original test data, and deviation and change handling records of the past 12 months, and interviewed relevant departments on raw material supplier audits, change management and customer complaint handling.

The audit was passed successfully. The auditing party affirmed our site management and document control, and raised two improvement suggestions, which the company has included in its corrective action plan with assigned owners and deadlines. The company will continue to improve its communication and collaboration mechanism with MAHs, faithfully fulfill quality agreements, and cooperate in supplier audits, complaints and recalls and other quality activities.