Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions.
Environmental control system s shall be periodically inspected to verify that the system, including necessary equipment, is adequate and functioning properly. These activities shall be documented and reviewed. Each manufacturer shall establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality.
The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality. Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mixups, and assure orderly handling.
Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met.
Maintenance activities, including the date and individual s performing the maintenance activities, shall be documented. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules.
The inspections, including the date and individual s conducting the inspections, shall be documented. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.
Where a manufacturing material could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device's quality. The removal or reduction of such manufacturing material shall be documented.
When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.
Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented. Calibration procedures shall include specific directions and limits for accuracy and precision.
When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
The validation activities and results, including the date and signature of the individual s approving the validation and where appropriate the major equipment validated, shall be documented. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification 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. 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. 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:. Each manufacturer shall document acceptance activities required by this part. These records shall include:. Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance 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.
Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.
The evaluation and any investigation shall be documented. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual s authorizing the use.
Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.
The procedures shall include requirements for:. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use. Labeling shall not be released for storage or use until a designated individual s has examined the labeling for accuracy including, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and any additional processing instructions.
The release, including the date and signature of the individual s performing the examination, shall be documented in the DHR. Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mixups. Each manufacturer shall control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.
Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.
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. 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.
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. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections.
Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee s.
Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.
Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.
Each manufacturer shall maintain device master records DMR's. The DMR for each type of device shall include, or refer to the location of, the following information:. Each manufacturer shall maintain device history records DHR's. Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part.
The DHR shall include, or refer to the location of, the following information:. Each manufacturer shall maintain a quality system record QSR. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
Such procedures shall ensure that:. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate. The record of investigation shall include:. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed.
Authority: 21 U. Source: 61 FR , Oct. Skip to main content. Have questions on what Emergo can do for you? Subpart B--Quality System Requirements. Subpart F--Identification and Traceability. Subpart G--Production and Process Controls. Subpart H--Acceptance Activities. Subpart I--Nonconforming Product. Subpart J--Corrective and Preventive Action. The series includes updated rules deeming items that statutorily come under the definition of 'tobacco product' to be subject to the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act.
The items affected include E-cigarettes, Hookah tobacco, and pipe tobacco. The series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act:. Notable sections: 11 — electronic records and electronic signature related 50 Protection of human subjects in clinical trials 54 Financial Disclosure by Clinical Investigators [2] 56 Institutional Review Boards that oversee clinical trials 58 Good Laboratory Practices GLP for nonclinical studies The series are regulations pertaining to food: , especially Requirements for new drugs et seq.
Specific requirements for over-the-counter OTC drugs. The series are regulations for animal feeds and animal medications: et seq. New animal drugs Tolerances for residues of drugs in food animals The series covers biological products e. Listing of specific approved devices and how they are classified The series covers mammography quality requirements enforced by CDRH. Interstate shipment of African rodents that may carry monkeypox. Sanitation on interstate conveyances i.
US FDA.
0コメント