Recently, Many domestic responsible persons for imported cosmetics in Shanghai have received on-site inspection notices and received the “Risk assessment on Quality Management and On-site Evaluation Guidelines for Domestic Responsible Persons of Imported General Cosmetics in Shanghai”.
The Guidelines evaluate the responsible person of General cosmetics from aspects like the basic information of responsible person, personnel and training, adverse reactions, procurement and acceptance, recall management, sample management, sales records and electronic case records.
Recently, CosmeticsBridge assists our clients to complete the on-site evaluation and summarize the main points of on-site inspection as follows:
(1) Warehouse: need to provide the warehouse property certificate, or a valid lease contract or agreement; warehouse management documents; temperature and humidity record sheet; pest record sheet.
(2) Enterprise: Take pictures of the working environment; quality and safety agreements, purchase contracts, and orders signed with overseas recorders; sales contracts with distributors need to specify the work content of adverse reactions and recalls; list of registered products.
(3) Personnel: check personnel control procedures and personnel health management system; company organization chart and statistics of the number of people in each department; job description; check training system, training plan, training content; quality manager resume (or entry form); warehouse and Health certificate of quality personnel (physical examination report).
(4) Adverse reactions: check the adverse reaction system; ask how the company’s adverse reaction monitoring works, how to communicate with and deal with the overseas filing person; set up positions for adverse reaction monitoring and be familiar with the adverse reaction monitoring system.
(5) Procurement and Inspection: check the cosmetics inspection system and report; the responsibilities and obligations of both parties must be specified in the contract signed with the warehouse.
(6) Recall: Check the product recall system, recall records or simulated recall records; the person in charge of quality is familiar with the recall procedure.
(7) Samples Retention : check the retention sample system, retention sample records; spot-check different batches of retention samples, each batch of products needs to retain 1 sample.
(8) Sales records: check the sales system, sales records, sales products, customs declaration forms; foreign sales certificates (photos of counters, sales records, etc.); inquire about the implementation of the warehouse inventory.
(9) Electronic records: Check the related systems of electronic records, ask about the backup frequency of ERP system data, and the measures to ensure data security.
