According to the Code of Federal Regulations (21 CFR 820.80 Acceptance Activities), each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, test, or other verification activities. Each manufacturer needs established acceptance procedures for receiving materials, in-process product and final finished devices. Each manufacturer will document the acceptance activities required in the device history record (DHR). Records should include the activities performed, the dates the activities were performed, the results of the activities, the signature of the individual(s) conducting the activities and where appropriate, the equipment used.
A company recently received the following observation:
…. Procedures for acceptance activities have not been established.
Specifically, you have not established procedures for incoming product and finished device acceptance activities for your … test system, to ensure that the devices conform to specified requirements and meet acceptance criteria, and that acceptance records are maintained. For example, … Tests in the 7T box configuration (7 Tests per box) distributed for investigational use (e.g.. Lot … and … tests in the 3T box configuration (3 Tests per box) distributed for non-investigational purposes (lot# …), were shipped with the incorrect Instructions for Use. These Tests were not inspected, tested, or otherwise verified when they were received from your contract manufacturer in China, or prior to shipment to the users.
According to GMP Trends® Annual Reports, observations pertaining to acceptance activities (21 820.80) was in the top 10 observations cited by the FDA last year.
For more information acceptance activities, refer to the FDA’s Presentation Document, Production and Process Controls, Part 2: Acceptance Activities, Handling, Storage, Distribution, and Installation.
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