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(i) Automated processes. 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.

special environmental conditions are appropriately trained or supervised by a trained individual.

(e) Contamination control. 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.

(f) Buildings. Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mixups, and assure orderly handling.

(g) Equipment. 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.

(1) Maintenance schedule. 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.

(2) Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures

ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.

(3) Adjustment. 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.

(h) Manufacturing material. 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.

to

$ 820.72 Inspection, measuring, and

test equipment. (a) Control of inspection, measuring, and test equipment. 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.

(b) Calibration. 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. These activities shall be documented.

(1) Calibration standards. 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.

(2) Calibration records. 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. $ 820.75 Process validation.

(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. 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.

(b) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s).

(2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.

(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.

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.

Subpart H-Acceptance Activities $ 820.80 Receiving, in-process, and fin.

ished 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

8820.86 Acceptance status.

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.

Subpart -Nonconforming

Product

$820.90 Nonconforming product.

(a) Control of nonconforming product. 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.

(b) Nonconformity review and disposition. (1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. 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.

(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.

tify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems; (2) Investigating

the cause of nonconformities relating to product, processes, and the quality system;

(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;

(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;

(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;

(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and

(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.

Subpart J-Corrective and

Preventive Action

8820.100 Corrective and preventive ac

tion. (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to iden

Subpart K-Labeling and

Packaging Control 8 820.120 Device labeling.

Each manufacturer shall establish and maintain procedures to control labeling activities.

(a) Label integrity. 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.

(b) Labeling inspection. 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.

(c) Labeling storage. Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mixups.

(d) Labeling operations. 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.

(e) Control number. Where a control number is required by $ 820.65, that control number shall be on or shall accompany the device through distribution.

8820.160 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.

8 820.130 Device packaging.

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.

Subpart 1-Handling, Storage, Distribution, and Installation

$ 820.140 Handling.

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. 8 820.150 Storage.

(a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, 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.

$ 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.

Subpart M-Records

8820.180 General requirements.

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 per- specifications, production methods, form inspections. Such records, includ- production procedures, and production ing those not stored at the inspected environment specifications; establishment, shall be made readily (c) Quality assurance procedures and available for review and copying by specifications including acceptance criFDA employee(s). Such records shall be teria and the quality assurance equiplegible and shall be stored to minimize ment to be used; deterioration and to prevent loss. (d) Packaging and labeling specificaThose records stored in automated tions, including methods and processes data processing systems shall be used; and backed up.

(e) Installation, maintenance, and (a) Confidentiality. Records deemed

servicing procedures and methods. confidential by the manufacturer may be marked to aid FDA in determining $820.184 Device history record. whether information may be disclosed

Each manufacturer shall maintain under the public information regula

device history records (DHR's). Each tion in part 20 of this chapter.

manufacturer shall establish and main(b) Record retention period. All records

tain procedures to ensure that DHR's required by this part shall be retained

for each batch, lot, or unit are mainfor a period of time equivalent to the

tained to demonstrate that the device design and expected life of the device,

is manufactured in accordance with the but in no case less than 2 years from

DMR and the requirements of this part. the date of release for commercial dis

The DHR shall include, or refer to the tribution by the manufacturer.

location of, the following information: (C) Erceptions. This section does not

(a) The dates of manufacture; apply to the reports required by

(b) The quantity manufactured; $ 820.20(c) Management review, $ 820.22 Quality audits, and supplier audit re

(c) The quantity released for dis

tribution; ports used to meet the requirements of $ 820.50(a) Evaluation of suppliers, con

(d) The acceptance records which tractors, and consultants, but does

demonstrate the device is manufacapply to procedures established under

tured in accordance with the DMR; these provisions. Upon request of a des

(e) The primary identification label ignated employee of FDA, an employee

and labeling used for each production in management with executive respon

unit; and sibility shall certify in writing that the

(f) Any device identification(s) and management reviews and quality au

control number(s) used. dits required under this part, and supplier audits where applicable, have

$ 820.186 Quality system record. been performed and documented, the Each manufacturer shall maintain a dates on which they were performed, quality system record (QSR). The QSR and that any required corrective action shall include, or refer to the location has been undertaken.

of, procedures and the documentation

of activities required by this part that 8820.181 Device master record.

are not specific to a particular type of Each manufacturer shall maintain device(s), including, but not limited to, device master records (DMR's). Each the records required by $ 820.20. Each manufacturer shall ensure that each

manufacturer shall ensure that the DMR is prepared and approved in ac- QSR is prepared and approved in accordance with $820.40. The DMR for cordance with $ 820.40. each type of device shall include, or refer to the location of, the following

$ 820.198 Complaint files. information:

(a) Each manufacturer shall main(a) Device specifications including tain complaint files. Each manufacappropriate drawings, composition, for- turer shall establish and maintain promulation, component specifications, cedures for receiving, reviewing, and and software specifications;

evaluating complaints by a formally (b) Production process specifications designated unit. Such procedures shall including the appropriate equipment ensure that:

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