(a) Authority. This Part 820 is established and promulgated under authority of sections 501, 502, 518, 519, 520(f), and 701(a) of the act (21 U.S.C. 351, 352, 360h, 360i, 360j(f) and 371(a)). The failure to comply with any applicable provisions in Part 820 in the manufacture, packing, storage, or installation of a device renders the device adulterated under section 501(h) of the act. Such adevice, as well as the person responsible for the failure to comply, is subject to regulatory action.
(b) Limitations. The current good manufacturing practice regulation in Part 820 supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other regulations.
(c) Applicability. The provisions of Part 820 shall be applicable to any finished device, as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
(d) Exemptions or variances. Any person who wishes to for an exemption or variance from any device good manufacturing practice requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in 10.30 of this chapter, the Food and Drug Administration's administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Compliance Programs, Manufacturing Quality Assurance Branch (HFZ 332) 1390 Piccard Dr., Rockville, MD 20850; telephone 301 427 1128. [43 FR 31508, July 21, 1978, as amended at 44 FR 75628, Dec. 21, 1979; 53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar. 27 1990]
(b) ``Audit'' means a documented activity performed in accordance with written procedures on a periodic basis to verify, by examination and evaluation of objective evidence, compliance with those elements of the quality assurance program under review. ``Audit'' does not include surveillance or inspection activities performed for the purpose of conducting a quality assurance program or undertaking complaint investigations or failure analyses of a device.
(c) ``Component'' means any material, substance, piece, part, or assembly used during device manufacture which is intended to be included in the finished device.
(d) ``Control number'' means any distinctive combination of letters or numbers, or both, from which the complete history of the manufacture, control, packaging, and distribution of a production run, lot, or batch of finished devices can be determined.
(e) ``Critical component'' means any component of a critical device whose failure to perform can be reasonably expected to cause the failure of a critical device or to affect its safety or effectiveness.
(f) ``Critical device'' means a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user. Critical devices will be identified by the Commissioner after consultation with the Device Good Manufacturing Practice Advisory Committee authorized under section 520(f) of the act, and an illustrative list of critical devices will be available from the Center for Devices and Radiological Health Food and Drug Administration.
(g) ``Critical operation'' means any operation in the manufacture of a critical device which, if improperly performed, can be reasonably expected to cause the failure of a critical device or affect its safety or effectiveness.
(h) ``Device history record'' means a compilation of records containing the complete production history of a finished device.
(i) ``Device master record'' means a compilation of records containing the design, formulation, specifications, complete manufacturing procedures, quality assurance requirements, and labeling of a finished device.
(j) ``Finished device'' means a device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution.
(k) ``Manufacturer'' means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles or processes a finished device. The term does not include any person who only distributes a finished device.
(l) ``Manufacturing material'' means any material such as a agent, mold-release agent, lubricating oil, or other substance used to facilitate a manufacturing process and which is not intended by the manufacturer to be included in the finished device.
(m) ``Noncritical device'' means any finished device other than a critical device.
(n) ``Quality assurance'' means all activities necessary to assure and verify confidence in the quality of the process used to manufacture a finished device.
[43 FR 31508, July 21, 1978, as amended at 53 FR 11253, Apr. 6, 1988]
(a) Quality assurance program requirements. The quality assurance program shall consist of procedures adequate to assure the following functions are performed:
(2) Approval or rejection of all components, manufacturing materials, in-process materials packaging materials, labeling, and finished devices; approval or rejection of devices manufactured, processed, packaged or held under contract by another company;
(3) Identifying recommending, or providing solutions for quality assurance problems and verifying the implementation of such solutions; and
(4) Assuring that all quality assurance checks are appropriate and adequate for their purpose and are performed correctly.
(b) Audit procedures. Planned and periodic audits of the quality assurance program shall be implemented to verify compliance with the quality assurance program. The audits shall be performed in accordance with written procedures by appropriately trained individuals not having direct responsibilities for the matters being audited. Audit results shall be documented in written audit reports, which shall be reviewed by management having responsibility for the matters audited. Followup corrective action, including reaudit of deficient matters, shall be taken when indicated. An employee of the Food and Drug Administration, designated by the Food and Drug Administration, shall have access to the written procedures established for the audit. Upon request of such an employee, a responsible official of the manufacturer shall certify in writing that the audits of the quality assurance program required under this paragraph have been performed and documented and that any required corrective action has been taken.
(a) Personnel training. All personnel shall have the necessary training to perform their assigned responsibilities adequately. Where training programs are necessary to assure that personnel have a thorough understanding of their jobs, such programs shall be conducted and documented. All employees shall be made aware of device defects which may occur from the improper performance of their specific jobs. Quality assurance personnel shall be made aware of defects and errors likely to be encountered as part of their quality assurance functions.
(b) Personnel health and cleanliness. Personnel in contact with a device or its environment shall be clean, healthy and suitably attired where lack of cleanliness, good health or suitable attire could adversely affect the device. Any personnel who, by medical examination or supervisory observation appear to have a condition which could adversely affect the device shall be excluded from affected operations until the condition is corrected. Personnel shall be instructed to report such conditions to their supervisors.
(a) Personnel sanitation. Washing and toilet facilities shall be clean and adequate. Where special clothing requirements are necessary to assure that a device is fit for its intended use, clean dressing rooms shall be provided for personnel.
(b) Contamination control. There shall be procedures designed to prevent contamination of equipment, components or finished devices by rodenticides, insecticides, fungicides fumigants, hazardous substances, and other cleaning and sanitizing substances. Such procedures shall be documented.
(c) Personnel practices. Where eating, drinking, and smoking by personnel could have an adverse effect on a device's fitness for use, such practices shall be limited to designated areas selected so as to avoid such an adverse effect.
(d) Sewage and refuse disposal. Sewage trash, by-products, chemical effluents, and other refuse shall be disposed of in a timely, safe, and sanitary manner.
(a) Maintenance schedule. Where maintenance of equipment is necessary to assure that manufacturing specifications are met, a written schedule for the maintenance, adjustment, and cleaning of equipment shall be developed and adhered to. Such schedule shall be visibly posted on or near each piece of equipment or be readily available to personnel performing maintenance activities. A written record shall be maintained documenting when scheduled maintenance activities are performed.
(b) Inspection. Periodic documented inspections shall be made to assure adherence to applicable equipment maintenance schedules.
(c) Adjustment. Any inherent limitations or allowable tolerances shall be visibly posted on or near equipment requiring periodic adjustments, or be readily available to personnel performing these adjustments.
(d) Manufacturing material. Manufacturing material, including acleaning agent, mold-release agent, lubricating oil, or other substance used on or in the manufacturing equipment or the device, shall be subsequently removed from the device or limited to a specified amount that does not adversely affect the device's fitness for use. There shall be written procedures for the use and removal of such manufacturing material. The removal of such manufacturing material shall be documented.
(a) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. There shall be provisions for remedial action when accuracy and precision limits are not met. Calibration shall be performed by personnel having the necessary education, training, background, and experience.
(b) Calibration standards. Where practical the calibration standards used for production and quality assurance measurement equipment shall be traceable to the national standards of the National Bureau of Standards, Department of Commerce. If national standards are not practical for the parameter being measured, an independent reproducible standard shall be used. If no applicable standard exists an in-house standard shall be developed and used.
(c) Calibration records. The calibration date, the calibrator and the next calibration date shall be recorded and displayed or records containing such information shall be readily available for each piece of equipment requiring calibration. A designated individual(s) shall maintain a record of calibration dates and of the individual performing each calibration.
(a) Acceptance of components. There shall be a written procedure for acceptance of components. A designated individual(s) shall accept or reject components. A record shall be maintained of component acceptance and rejection. Upon receipt, each shipping container of components shall be visually examined for damage. Where deviations from component specifications could result in the device being unfit for its intended use, components shall be inspected, sampled, and tested for conformance to specifications.
(b) Storage and handling of components. If the quality or fitness for use of components deteriorates over time, the components shall be stored in a manner to facilitate proper stock rotation. Component control numbers or other identifications shall be easily viewable. All obsolete, rejected or deteriorated components shall be clearly identified and segregated from accepted components. Records shall be maintained of the disposition of all obsolete, rejected, or deteriorated components.
(a) Acceptance of critical components. There shall be written procedures for the accepting, sampling, testing, and inspecting of all lots of critical components to assure that critical components conform to specifications. The number of units sampled from each lot of critical components shall be based upon an acceptable statistical rationale, the past quality history of the supplier and the quantity needed for analysis and reserve. Each lot of critical components shall be identified with a control number(s) upon receipt. The percentage of defective critical components for each lot and the percentage of lots rejected shall be recorded and identified by supplier name.
(b) Critical component supplier agreement. Where possible the manufacturer shall secure from the critical component supplier a written agreement whereby the supplier agrees to notify the manufacturer of any proposed change in a critical component. Where such an agreement exists, the manufacturer shall not accept such a change until the manufacturer has determined the impact of the change on the finished device.
(a) Specification controls.
(2) Specification changes shall be subject to controls as stringent as those applied to the original design specifications of the device. Such changes shall be approved and documented by a designated individual(s) and shall include the approval date and the date the change becomes effective.
(b) Processing controls.
(2) All processing control operations shall be conducted in a manner designed to assure that the device conforms to applicable specifications.
(3) There shall be a formal approval procedure for any change in the manufacturing process of a device. Any approved change shall be communicated to appropriate personnel in a timely manner.
(a) Critical operation performance. Any critical operation shall be performed by a suitable designated individual(s) or equipment and shall be verified.
(b) Record of critical operation. Any individual responsible for the performance of a critical operation shall record or reference that operation in the device history record as required in 820.185.
(b) Any device rejected during finished device inspection and later reprocessed shall be subject to another complete final inspection for any characteristic of the device which may be adversely affected by such reprocessing.
(a) Reprocessing procedures. There shall be written procedures for any reprocessing associated with the production of a critical device or component. These procedures shall prescribe the equipment to be used in reprocessing and shall include any special quality assurance methods or tests. The procedures shall be designed so that the reprocessed device or component meets the original, or subsequently modified and approved, specifications. The procedures shall be designed to prevent adulteration, e.g., because of material, structural or molecular change in the device or component due to reprocessing. Special care shall be taken to assure that the device or component to be reprocessed is clearly identified and separated from like devices or components not to be reprocessed. there is constant reprocessing of a device or component, a determination of the effect of the reprocessing upon the device or component shall be made and documented. There shall be a formal approval procedure for instituting a new, or altering an approved, reprocessing procedure.
(b) Reprocessing control. Any critical device or component subject to reprocessing procedures shall conform to the original, or subsequently modified and approved, specifications. Written testing and sampling procedures to assure such comformity shall be contained or referenced in the device master record. Any prior quality assurance check shall be repeated on the reprocessed device or component if the reprocessing could adversely affect any performance characteristic previously inspected.
(a) Label integrity. Labels shall be designed, printed, and applied so as to remain legible during the customary conditions of processing, storage handling, distribution, and use. Labels and other labeling shall not be released to inventory until a designated individual has proofread samples of the labeling for accuracy.
(b) Separation of operations. Each labeling or packaging operation shall be separated physically or spatially in a implementation of any labeling or packaging operation, the shall be an inspection of the area where the operation is to occur by a designated individual to assure that devices and labeling materials from prior operations do not remain in the labeling or packaging area. Any such items found shall be destroyed, disposed of, or returned to storage prior to the onset of anew or different labeling or packaging operation.
(d) Storage. Labels and labeling shall be stored and maintained in a manner that provides proper identification and is designed to prevent mixups.
(e) Labeling materials. Labeling materials issued for devices shall be examined for identity and, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and additional processing instructions. A record of such examination, including the date and person performing the examination, shall be maintained in the device history record.
(a) Control number. Labels issued for critical devices shall contain a control number.
(b) Labeling check. The signature of the individual who proofreads the labels and other labeling and the date of the proofreading, shall be recorded.
(c) Access restriction. Access to the labels and other labeling shall be restricted to authorized personnel.
(a) Confidentiality. Those records deemed confidential by the manufacturer may be marked to aid the Food and Drug Administration in determining information may be disclosed under the public information regulation in Part 20 of this chapter.
(b) Record retention period. All required records pertaining to a device 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. Photostatic or other reproductions of records required by this part may be used.
(a) Device specifications including appropriate drawings composition, formulation, and component specifications.
(b) Production process specifications including the appropriate equipment specifications, production methods production procedures, and production environment specifications.
(c) Quality assurance procedures and specifications including quality assurance checks used and the quality assurance apparatus used.
(d) Packaging and labeling specifications including methods and processes used.
(a) Critical components and critical component suppliers. Full information concerning critical components and critical component suppliers, including the complete specifications of all critical components, the sources where they may be obtained, and written copies of any agreements made with suppliers under 820.81(b).
(b) Labels and labeling. Complete labeling procedures for the individual device and copies of all approved labels and other labeling.
(a) Component documentation. The documentation of each critical component used in the manufacture of a device shall include:
(2) Acceptance record. The acceptance record of the critical component, including acceptance date and signature of the recipient.
(b) Record of critical operation. The record of, or reference to, each critical operation, identifying the date performed, the designated individual(s) performing the operation and, when appropriate, the major equipment used.
(c) Inspection checks. The inspection checks performed, the methods and equipment used, results, the date and signature of the inspecting individual.
(b) Any complaint involving the possible failure of a device to meet any of its performance specifications shall be reviewed evaluated, and investigated. Any complaint pertaining to injury, death, or any hazard to safety shall be immediately reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint file.
(c) When an investigation is made, a written record of each investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include the name of the device, any control number used, name of complainant, nature of complaint, and reply to complainant.
(d) Where the formally designated unit is located at a site separate from the actual manufacturing establishment, a duplicate copy of the record of investigation of any complaint shall be transmitted to and maintained at the actual manufacturing establishment in a file designated for device complaints.