Complaints and Recalls. 5.01 Have written procedures in place to document, investigate, and respond to all quality related complaints. π π πΉ 5.02 Assist in investigations as reasonably requested by Client for complaints associated with Product. π π πΉ 5.03 Retain complaint investigation records and evaluate trends and severity. Implement corrective and preventive actions as necessary. π π πΉ 5.04 Suppliers will have procedures in place to facilitate the recall of an API as necessary. Suppliers will provide assistance to the client for the recall of drug product incorporating the supplierβs API. π πΉ πΉ
Appears in 1 contract
Sources: Quality Agreement
Complaints and Recalls. 5.01 Have written procedures in place to document, investigate, and respond to all quality related complaints. π πο― ο― οΎ πΉ
5.02 Assist in investigations as reasonably requested by Client for complaints associated with Product. πο― ο― οΎ π πΉ
5.03 Retain complaint investigation records and evaluate trends and severity. Implement corrective and preventive actions as necessary.ο― ο― οΎ π π πΉ
5.04 Suppliers will have procedures in place to facilitate the recall of an API as necessary. Suppliers will provide assistance to the client for the recall of drug product incorporating the supplierβs Aο― οΎ οΎPI. π πΉ πΉ
Appears in 1 contract
Sources: Quality Agreement