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Part 3 Good Manufacturing Practices for Medical Devices
Chapter 3 Essential Mode
Article 124
Manufacturers shall appoint a member of its own management who, irrespective of other responsibilities, shall have defined authority for the following tasks:
(1) Ensuring that a quality system is established, implemented and maintained in accordance with this Chapter;
(2) Reporting on the performance of the quality system to the management for review and as a basis for improvement of the quality system;
(3) Ensuring the safety and effectiveness of manufactured medical devices.
Article 125
Manufacturers shall establish and maintain a file for manufacturing procedures, installation and servicing, or referring to the location(s) of this information. Their file or information shall contain documents defining the product specifications and quality system requirements (including process and quality assurance) for each type or model of medical device.
Article 126
All design changes and modifications of manufacturers shall be identified, documented, reviewed and approved by authorized personnel before their implementation.
Article 127
Manufacturers shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this Chapter.
Article 128
Manufacturers shall adopt the following measures with respect to subcontractors:
(1) Evaluating and selecting subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements;
(2) Defining the type and extent of control exercised over subcontractors depending upon the type of product, the impact of subcontracted product on the quality of final product; and, where applicable, also taking into account the quality audit reports or quality records of the previously demonstrated capability and performance of subcontractors; and
(3) Establishing and maintaining quality records of subcontractors.
Verification by the customer shall not be used by manufacturers as evidence for their effective quality control of subcontractors.
Article 129
Manufacturers shall require that their agents or distributors maintain and retain records of the distribution of medical devices and that such records are available for inspection.
Article 130
Manufacturers shall identify and plan the production, installation and servicing processes which directly affect quality and shall ensure that these processes are carried out under controlled conditions.
The above controlled conditions shall include the following:
(1) Documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely affect quality;
(2) Use of suitable production, installation and servicing equipment, and a suitable working environment;
(3) Compliance with all types of reference codes, standards, quality plans or documented procedures;
(4) Monitoring and control of suitable process parameters and product characteristics;
(5) The approval of processes and equipment, as appropriate;
(6) Criteria for workmanship stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations);
(7) Suitable maintenance of equipment to ensure continuing process capability.
Where the results of processes cannot be fully verified by subsequent inspection and testing of the product (including processing deficiencies that may become apparent only after the product is in use), the processes shall be carried out by qualified operators or shall require continuous monitoring and control of process parameters to ensure that the specified requirements are met.
The requirements for any qualification of process operations, including associated equipment and personnel, shall be specified.
Article 131
Manufacturers shall establish and maintain documented procedures for inspection and testing activities in order to verify that the specified requirements for the product are met.
Article 132
Manufacturers shall carry out final inspection and testing and prepare records in accordance with the quality plan or documented procedures to ensure conformance of the finished product to the specified requirements.
Article 133
Manufacturers shall establish and maintain records which provide evidence that the product has been inspected and/or tested.
The above records shall include the following:
(1) Showing clearly whether the product has passed or failed the inspections or tests according to defined acceptance criteria. Where the product fails to pass any inspection or test, the procedures for control of nonconforming product shall apply;
(2) Identifying the inspection authority responsible for the release of product.
Article 134
Manufacturers shall establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by them to demonstrate the conformance of product to the specified requirements.
The above inspection, measuring and test equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.
Article 135
Manufacturers shall identify the inspection and test status of product by suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed.
Article 136
Manufacturers shall establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation.
The above control shall provide for identification, documentation, evaluation, segregating (when practical), disposition of nonconforming product, and for notification to the functions concerned.
Article 137
Manufacturers shall establish and maintain documented procedures for implementing corrective and preventive action.
Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered.
Manufacturers shall implement and record any changes to the documented procedures resulting from corrective and preventive action.
Manufacturers shall establish and maintain a documented feedback system to provide early warning of quality problems and for input into the corrective and preventive action system.
Manufacturers shall gain experience from information feedback in the post-production phase, and the review of this experience shall form part of the feedback system.
Manufacturers shall maintain records of all customer complaint investigations. When the investigation determines that the activities at remote premises contributed to the customer complaint, relevant information shall be communicated between the manufacturer and the remote premises.
If any customer complaint is not followed by corrective and preventive action, the reason shall be recorded.
Manufacturers shall establish reporting procedures to notify the central competent health authority of those incidents in which a harmful event has occurred.
Manufacturers shall establish and maintain documented procedures for the issue of advisory notice for medical devices, and ensure these procedures shall be capable of being implemented at any time.
Article 138
Manufacturers that manage the handling, storage, packaging, preservation and delivery of product shall comply with the following requirements:
(1) Handling: Appropriate methods for handling product that prevent damage or deterioration shall be provided.
(2) Storage: Designated storage areas or stock rooms shall be used to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated. In order to detect deterioration, the condition of product in stock shall be assessed at appropriate intervals.
(3) Packaging: Packing and marking processes (including materials used) shall be controlled to the extent necessary to ensure conformance to specified requirements.
(4) Preservation: Appropriate methods for preservation and segregation of product shall be applied when the product is under the manufacturer’s control.
(5) Delivery: Protection of the quality of product shall be arranged for after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination.
Article 139
Manufacturers shall establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records.
Quality records of manufacturers and their control shall conform to the following requirements:
(1) Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.
(2) Pertinent quality records from the subcontractor shall be part of the records.
(3) Quality records shall be retained for a period of time at least equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than two years from the date of dispatch from the manufacturer.
(4) All quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss.
(5) Where agreed contractually, quality records shall be made available for evaluation by the customer for an agreed period.