21 CFR 820 - 820.80 receiving, in-process and finished device accePtance

Original text

Expert opinion

(a) General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.

For any product, acceptance procedures must be implemented as written procedures. The procedures must include at least the identification of the good or service, steps for inspection, testing or verification as well as a decision on the acceptance.

Please note that “product” in this context means medical device.

(b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.

Incoming products must be either accepted or rejected, based on written procedures and according to pre-defined specifications. The decision on rejection or acceptance must be documented.

(c) In-process acceptance activities. Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.

For products refered to as in-process products or semi-finished products, in-process controls must be established according to pre-defined specifications or requirements. The in-process products should be halted from being further processed till all testing has concluded and approvals have been given.

(d) Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:

(1) The activities required in the DMR are completed;

(2) the associated data and documentation is reviewed;

(3) the release is authorized by the signature of a designated individual(s); and

(4) the authorization is dated.

Finished medical devices have to be checked against acceptance criteria. This final release testing needs to be conducted according to written procedures and with the aim to provide specification conforming products to the market. It is demanded that each lot, batch, run or however a sequence of manufacturing is called (except the continuous manufacturing sequences) is held in quarantine till checked and released. In fact, there are 4 points to complete before releasing the product to market.

(e) Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:

(1) The acceptance activities performed;

(2) the dates acceptance activities are performed;

(3) the results;

(4) the signature of the individual(s) conducting the acceptance activities; and

(5) where appropriate the equipment used. These records shall be part of the DHR.

The acceptance procedure and activities must be implemented and available in written. Further, the written records for the acceptance activities must include, according to this regulation, the 5 points given in 820.80.

Any questions left? Contact Avanti Europe to discuss with an expert