condom manufacturer inspection checklist
Welcome the FDA or MOH from abroad coming and inspecting our factory. The good quality management system and strictly condom quality control get the high praise from clients. We’re a middle enterprise condom factory-shandong ming yuan latex co.,ltd. Focus on custom condoms with private logo, welcome clients work their own brand condom together with us. The instant service and competitive price and quality focus is our promise. Your brand condom deserves a qualified condom factory.
During UNFPA’s inspection, Use the following checklist to score the suitability of the manufacturer for a remote inspection of male latex condom manufacturers.
1 Is the manufacturer’s overall status with respect to change control, risk
management, process and product compliance to client and regulatory
requirements acceptable (yes = 20, no = 0)
2 Is the manufacturing site already prequalified (yes = 20, no = 0)
3 Assessment of submitted documentation (poor = 0, excellent = 10)
4 Are the manufacturer’s information technology (IT) facilities judged to be
acceptable for a remote inspection (poor = 0, excellent = 10)
5 Assessment of the quality record of the manufacture (poor = 0, excellent = 10)
6 Assessment of the manufacturer’s complaints record (poor = 0, excellent = 10)
7 Have all past CAPAs been resolved (yes = 10, no = 0)
8 Assessment of the quality of submitted QC data (poor = 0, excellent = 10)
9 Assessment of independent pre-shipment test reports (poor = 0, excellent = 10)
10 Have there been any in-country lot rejections (yes = 0, no = 10)
11 Have there been any major changes in processes or equipment since last inspection
(yes = 0, no = 10)
12 Have there been any major changes in senior management since last inspection
(yes = 0, no = 10)
13 Assessment of the internal audit reports (poor = 0, excellent = 10)
14 Assessment of minutes and reports of the Management Review Meetings
(poor = 0, excellent = 10)
Welcome contact us if you plant build own brand condom, we can help you in the plant’s registration: [email protected]
