FDA Quality Acceptance Regulations | QSR’s
Information & Training. | Medical Devices.Procedures and specifications for all inspections and tests need to be defined and documented. This requirement covers all inspection and test points from receiving raw materials, through in-process testing through to final inspection. The inspections and tests need to be structured to ensure the critical attributes which could impact product quality, safety or efficacy are all verified as meeting specified requirements.
Final inspection will also include a review of the device master record (DMR). The DMR will be verified as confirming that all required inspections and tests have been performed and successfully completed prior to device release for use.
Records of the inspections and tests will detail the dates of the tests, the signature of who performed the tests, tests performed and results.
The acceptance status of product needs to be clearly visible, either by virtue of its location, via labels, etc..
FDA Quality Acceptance Regulations – QSR’s.
Subpart H– FDA Quality Acceptance ActivitiesSec. 820.80 Receiving, in-process, and finished device acceptance.
a) General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.
(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.
(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.
(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.
(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.
Sec. 820.86 FDA Quality Acceptance Status.Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or non-conformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed.
Information & Training.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
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