A company recently received this 483 observation:
….. The program for evaluating and monitoring supplies of raw materials is not adequate.
a. Your firm has not conducted vendor qualification for the supplier of raw materials used in the manufacturing of … API.
b. Your firm’s Production Manager stated … was manufactured at the firm until several years ago. QC/QA Manager stated that after this date the firm purchased … from an outside vendor and shipped to different markets including the United States by relabeling under the name of their firm. QA/ Manager and Production Manager stated that the … purchased from a new vendor is not qualified and not approved by the firm. Your firm has no procedure for supplier qualification.
For more observations pertaining to API controls, see Issue 1047 available today. It also has observations pertaining to lab controls, manufacturing controls, and medical devices.