FDA QSR Regulations. Installation, Handling, Storage, Distribution.
Information & Training. | Medical Devices.Approved procedures need to be in-place which define and control the device in terms of how it is handled, stored, distributed and installed. The objectives of these procedures must be to ensure the quality of the finished device is not compromised, also to ensure there are no opportunities for product mix-ups. The processes and controls for release of product through the various stages within production, into finished inventory, through market distribution all need to be defined, with clear control points which prevent release and use of product which has not completed all required manufacturing and test stages.
Distribution records should be maintained which record what devices were shipped, when shipped, who shipped to and also record any necessary identification and traceability identifiers.
If there are environmental requirements for the device in storage and in transit, then these need to be defined and controls established to ensure such environmental requirements are continually achieved.
Where a device has specific installation requirements, the requirements need to be documented and processes established and monitored to ensure correct installation.
21 CFR 820 PART 820 QUALITY SYSTEM REGULATION
Subpart L–Handling, Storage, Distribution, and Installation
Sec. 820.140 Handling.
Each manufacturer shall establish and maintain procedures to ensure that mix-up’s, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.
Sec. 820.150 Storage.
(a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-up’s, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate.
(b) Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms.
Sec. 820.160 Distribution.
(a) Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device’s fitness for use or quality deteriorates over time, the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed.
(b) Each manufacturer shall maintain distribution records which include or refer to the location of:
(1) The name and address of the initial consignee;
(2) The identification and quantity of devices shipped;
(3) The date shipped; and
(4) Any control number(s) used.
Sec. 820.170 Installation.
(a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device.
(b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer’s instructions and procedures and shall document the inspection and any test results to demonstrate proper installation.
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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