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RDC16 2013

发布时间:2014-02-20 18:46:01  

Note: The translation from Portuguese to English used as reference

the basic terminology of the FDA QSR 21 Part 820.

ANVISA - COLLEGIATE BOARD RESOLUTION

Approves the Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use and other measures.

The Board of the National Health Surveillance Agency, in exercise of the powers conferred upon him by section IV of article. 11 of the Regulation approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of section II and in § 1 and § 3 of art. 54 of the Bylaws approved in accordance with Annex I of Ordinance No. 354 of ANVISA, of August 11, 2006, republished in the Official Gazette of August 21, 2006, at a meeting held March 7, 2013, considering the Law. 6360 of September 23, 1976 and its regulations, Decree No. 79094 of January 5, 1977;

considering the need to internalize the Resolution MERCOSUR / GMC / RES. No. 20/11, which approved the "MERCOSUR Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use (repeal of

GMC Resolution No. 04/95, 38/96, 65/96 and 131/96) ";

considering that the rules of Good Manufacturing Practices relating to medical products and products for in vitro diagnostic use should seek to guarantee the quality, safety and efficacy of the products marketed in Brazil;

Whereas it is essential to promote the improvement of national systems aimed at the regulation and control of medical products and products for in vitro diagnostic use;

adopts the following resolution of the Board and I, the Chairman, determine its publication:

Art 1st - Approve the "Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use", which is included as Annex and part of this resolution.

Single paragraph. This regulation incorporates the national legal system Resolution GMC MERCOSUR No. 20/2011 "MERCOSUR Technical Regulation of Good Manufacturing Practice for Medical Products and Products for Diagnostic Use In Vitro (repeal of GMC Resolution No. 04/95, 38/96, 65/96 and 131/96) ".

Article 2: - Repealing Ordinance No. 686, of August 27, 1998, the RDC Resolution No. 59, dated June 27, 2000, and Resolution RDC No. 167 of July 2, 2004.

Article 3 - Distributors and storage/hosts of medical products and diagnostic products for use in vitro should meet the requirements of this Resolution, as applicable.

Article 4 - It is granted within 180 days from the date of incorporation of the legislative instrument, to adopt the measures necessary for the implementation of the Technical Regulations.

Article 5 - This Resolution shall enter into force on the date of its publication.

DIRCEU BRáS APARECIDO BARBANO

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ANNEX

TECHNICAL REGULATION OF GOOD MANUFACTURING PRACTICES FOR

MEDICAL PRODUCTS AND

PRODUCTS FOR IN VITRO DIAGNOSTIC USE

CONTENT

CHAPTER 1 - GENERAL PROVISIONS

CHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM

2.1. General provisions

2.2. Managerial responsibility

2.3. Staff

2.4. Risk Management

2.5. Purchasing Control

CHAPTER 3 - DOCUMENTS AND RECORDS OF QUALITY

3.1. General requirements

3.2. Device History Record (DHR)

3.3. Records of inspections and tests.

CHAPTER 4 - DESIGN CONTROL AND DEVICE MASTER RECORD (DMR)

4.1. Design Control

4.2. Device Master Record (DMR)

CHAPTER 5 - PROCESS AND PRODUCTION CONTROLS

5.1. General Instructions

5.2. Controls packaging, labeling and instructions for use

5.3. Inspection and testing

5.4. Inspection and test of measuring equipments.

5.5. Validation

5.6. Change Control

CHAPTER 6 - HANDLING, STORAGE, DISTRIBUTION AND TRACEABILITY

6.1. Handling

6.2. Storage

6.3. Distribution

6.4. Identification and traceability

6.5. Non-compliant components and products

SECTION 7 - PREVENTIVE AND CORRECTIVE ACTIONS

7.1. Corrective and Preventive Actions

7.2. Management of complaints

7.3. Quality audit

CHAPTER 8 - INSTALLATION AND SERVICING

8.1. Installation

8.2. Technical Assistance/Servicing

CHAPTER 9 - STATISTICAL TECHNIQUES

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CHAPTER 1 - GENERAL PROVISIONS

1.1 - Applicability

1.1.1. This Technical Regulation establishes requirements for the manufacture of medical products and products for in vitro diagnostic use. These requirements describe the Good Manufacturing Practices (GMP) for methods and controls used in the design, purchase, manufacturing, packaging, labeling, storage, distribution, installation and servicing of medical products and products for in vitro diagnostic use. The requirements of this Technical Regulation are intended to ensure that medical products and products for in vitro diagnostic use are safe and effective.

1.1.1.2. The requirements of this Technical Regulation are applicable to manufacturers and importers of medical devices and diagnostic products for use in vitro that are commercialized in Brazil.

1.1.3. Where the manufacturer understand that any of the requirements of this resolution does not apply to their cases, shall document justification for such understanding.

1.1.1.4. Importers of medical and diagnostic products for use in vitro should meet the requirements of this Resolution, as applicable.

1.2. Definitions

For the purposes of this Technical Regulation the following definitions apply:

1.2.1. Technical Assistance/Servicing: Maintenance or repair of a finished product to return it to your specifications.

1.2.2. Audit quality: means an established examination, systematic and independent of all quality system from a manufacturer, performed at regular intervals and with sufficient frequency to ensure that either the activities of the quality system or their results satisfy the procedures specified in your quality system, and that these procedures are implemented efficiently and that are appropriate to achieve the objectives of the quality system. The quality audit is different from other activities of the quality system required by this Technical Regulation.

1.2.3. Component: raw material, substance, piece, part, software, hardware, packaging, labeling or instructions for use which are used during the manufacture of a medical product and product for diagnostic use in vitro, to be included as part of the finished product.

1.2.4. Project /Design Input : description of physical attributes, indication for use, performance, compatibility, security, efficiency, ergonomics, usability, information from previous projects and results of risk management, among other requirements of a medical device or diagnostic product use in vitro that are used as the basis for your project.

1.2.5. Project/Design Output : outcome of the work in each phase of the project and its final result. The output data of finished project is the basis for the product master record (PMR)/Device Master Record (DMR) .

1.2.6. Damage: physical injury or harm to the health of the person, or damage to property or the environment.

1.2.7. Specifications: requirements that products, components, production activities, technical assistance services, quality system or any other activity must conform.

1.2.8. Establish: define, document (through written or electronic) and implement.

1.2.9. Manufacturer: means any person who designs, manufactures, assembles or processes a finished product, including those who perform contract sterilization, labeling, packaging.

1.2.10. Executive management: top management responsible for providing resources and authority to establish or change policy and quality system of the company.

1.2.11. Risk Management: the systematic application of policies, procedures and management practices to the tasks of analyzing, evaluating, controlling and monitoring risks associated with a particular product or process.

1.2.12. Lot or batch: quantity of a product produced in a cycle of manufacturing or sterilization, whose essential characteristic is homogeneity.

1.2.13. Manufacturing Material: material or substance used in the manufacturing process or to facilitate this process, including cleaning agents, mold release agents, lubricants, sterilizing, or other byproducts of the manufacturing process.

1.2.14. Nonconformity: non-fulfillment of requirements specified in advance.

1.2.15. Serial Number or Lot: distinctive combination of letters or numbers, or both, which can be given a complete history of purchasing, manufacturing, packaging, labeling and distribution of finished products.

1.2.16. Hazard: Potential source of harm.

1.2.17. Quality Policy: all the intentions and directives of an organization with regard to quality, expressed by executive management.

1.2.18. Special Process: any process whose results cannot be fully verified by subsequent inspection and testing.

1.2.19. Production: all operations involved in the manufacture of a product, from receipt of components, through processing and packaging, to obtain the finished product.

1.2.20. Finished product: any product or accessory suitable for use, packed, labeled.

1.2.21. Quality: the totality of features and characteristics that enable a medical product or product for diagnostic use in vitro meet the requirements of fitness for use, including safety and performance.

1.2.22. Complaint: written communication, oral or electronic on the rejection of identity, quality, durability, reliability, safety, effectiveness, or performance of a product.

1.2.23. Records: physical or electronic document, which shows data, facts, specific events and achievements in relation to compliance with standards and procedures of the quality system.

1.2.24. Historical record of the compilation of records containing the complete history of producing a finished product.

documents containing the complete history of the project to a finished product.

1.2.26. Product Master Record compilation of documents containing specifications, instructions and procedures to obtain a finished product as well as installation, service and maintenance.

1.2.27. Rework: part or all of the manufacturing operation designed to correct non-conformity of a component, the intermediate product or a finished product, so that it meets the specifications set out in PMR/DMR.

1.2.28. Project/Design review: examination documented, systematic and complete performed during the development of the project to assess the adequacy of the same planning and objectives.

1.2.29. Risk: Combination of the probability of occurrence and severity of damage.

1.2.30. Quality system: organizational structure, responsibilities, procedures, specifications, processes and resources for quality management.

1.2.31. Validation: Confirmation by examination and objective evidence that the requirements defined for a particular purpose lead, consistently, the expected result. With respect to a project, means to establish and document objective evidence that the product specifications meet user needs and its intended use. With respect to a process means to establish and document objective evidence that the process will consistently produce a result that meets the predetermined specifications.

1.2.32. Verification: confirmation by examination and presentation of objective evidence that specified requirements have been met. The verification process includes examining the results of an activity to determine compliance with established specifications.

1.2.33. Life time: time estimated by the manufacturer that a product complies correctly functions for which it was designed.

CHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM

2.1. General Provisions

2.1.1. Each manufacturer shall establish and maintain a quality system to ensure that the requirements of this Technical Regulation are met and that the products manufactured are safe, effective and appropriate for the intended use. As part of its activities on the quality system, each manufacturer must:

2.1.1.1. Establish and maintain instructions and effective quality system procedures in accordance with the requirements of this Technical Regulation, and

2.1.1.2. Establish procedures for compliance with the legal provisions contained in current health/sanitary surveillance laws.

2.2. Managerial responsibility

2.2.1. Quality Policy. The executive management of each manufacturer shall establish its policy and objectives of commitment to quality, which should be measurable and consistent with the established policy. Executive management should maintain the policy at all levels of the organization. Executive management should ensure that this policy is described in a quality manual and understood by all employees who may affect or influence the quality of a product.

2.2.2. Organization. Each manufacturer shall establish and maintain an appropriate organizational structure, represented by the organization chart, with sufficient staff to ensure that products are manufactured in accordance with the requirements of this Technical Regulation.

2.2.3. Responsibility and Authority. Each manufacturer shall establish, for each chapter of this Technical Regulation, responsibility, authority and interrelation of all personnel who manage, perform and verify work relating to quality, with the necessary independence to perform its responsibilities.

2.2.4. Resources and personnel for verification. Each manufacturer shall establish verification functions, and must provide adequate resources and assignment of trained personnel to carry out verification activities.

2.2.5. Management representative. The executive management of each manufacturer shall designate an individual of this, and document this designation, which, irrespective of other functions, will have authority and responsibility for:

2.2.5.1. Ensure that the requirements of the quality system are established and maintained in accordance with this Technical Regulation;

2.2.5.2. Report the performance of the quality system to executive management for review and providing information on the improvement of the quality system.

2.2.6. Management review. The executive management of each manufacturer should evaluate the adequacy and effectiveness of the quality system at defined intervals and with sufficient frequency to ensure that the quality system satisfies the requirements of this Technical Regulation, and complies with the objectives of the quality policy established. The management review shall be conducted in accordance with established review procedures and the results of each review of the quality system shall be documented.

Should be considered for review matters relating to audit results, post-marketing information, process performance and product conformity, status of preventive and corrective actions, changes that could affect the quality system or product compliance, regulatory requirements, among other .

2.3. Personnel

2.3.1. General Instructions. Each manufacturer shall have sufficient personnel with education, experience, training and practice consistent with the duties of the position, to ensure that all activities under this Technical Regulation are correctly performed. Should be kept descriptions defining authority, responsibility and requirements for the various tasks of the company.

2.3.2. Training. Each manufacturer shall ensure that all personnel are adequately trained to perform the tasks assigned to it. Training shall be conducted in accordance with procedures established by qualified persons to ensure that employees have a proper understanding of their regular duties and requirements of this Technical Regulation applicable to their duties.

As part of their training, all employees should be warned of defects in products may occur as a result of improper performance of their specific functions.

The employee training should be documented.

2.3.3. Consultants. Each manufacturer shall ensure that any consultant to guide employees on methods and controls used for the design, purchase, manufacturing, packaging, labeling, storage, installation or servicing of products has sufficient qualifications (education, training and experience) to advise on matters for which he was hired.

Hiring consultants should be conducted in accordance with the requirements of Purchasing Control under this Technical Regulation.

2.4. Risk Management

2.4.1. Each manufacturer shall establish and maintain an continuous process of risk management which involves the entire product life cycle, from conception to its discontinuation, to identify the hazards associated with a medical device or product for in vitro diagnostic use, assess and evaluate the risks involved, monitor them and evaluate the effectiveness of established controls. This program should include the following elements: analysis, evaluation, control and monitoring of risk.

2.4.2. The executive management of the company shall designate the responsible professionals, establish policy for determining the criteria for acceptability of risk, and determine a periodic review of the risk management activities to ensure the adequacy and effectiveness of the same.

2.5. Purchasing Control

2.5.1. Each manufacturer shall establish and maintain procedures to ensure that components, manufacturing materials and finished products manufactured, processed, packaged or labeled by others or stored by them under the contract, are under conformity with the specifications. Each manufacturer shall also

ensure that the services performed by third parties are under conformity with the specifications laid down by it.

2.5.2. Evaluation of suppliers of products and services. Each manufacturer shall establish and maintain, according to the impact on the quality of the final product, criteria for evaluating suppliers,; specifying the requirements, including quality requirements, that they should meet.

2.5.3. Each manufacturer shall evaluate and select potential suppliers according to their ability to meet the requirements previously established, keeping record of approved suppliers. Records must be kept of the assessment records, as well as their results.

2.5.4. Purchase record. Each manufacturer shall maintain records of purchase orders that clearly describe or refer to the specifications, including quality requirements for components, manufacturing materials, finished products or services requested or contracted. The approval of applications, including the date and or electronic signature of the person responsible, must be documented.

2.5.5. Must be documented agreement that suppliers undertake to notify the manufacturer of any change in the product or service, so that the manufacturer can determine if the change affects the quality of the finished product.

2.5.6. Each manufacturer shall review and approve purchasing documents before their release.

CHAPTER 3 - DOCUMENTS AND RECORDS OF QUALITY

3.1. General requirements.

3.1.1. Each manufacturer shall establish and maintain document control procedures to ensure that all documents referenced in this Technical Regulation are correct and suitable for the intended use, and are understood by all employees who may affect or influence the quality of a product.

3.1.2. Approval and issuance of documents. Each manufacturer shall designate persons to review and approve all documents set forth in this Technical Regulation for adequacy prior to issue. The approval, including the date and or electronic signature of the person responsible for approving the document, shall be documented.

3.1.3. Distribution of documents. The manufacturer shall ensure that all documents are updated and available at the sites of application and that all unnecessary or obsolete documents are removed from use, or protected from unintended use.

3.1.4. Change documents. Changes in specifications, methods or procedures relating to the quality system must be evaluated, documented, reviewed and

approved by people whose role and level of responsibility are equivalent to those that performed the original review and approval.

3.1.5. Records document changes. Each manufacturer shall maintain records of changes to documents shall contain a description of the change, identification of affected and altered documents, identification of the responsible person, date of approval and date on which the changes will take effect.

Should be kept current list of documents to identify the current status of the same and ensure that they use only current and approved documents.

3.1.6. Document Archive and Records. All documents and quality records shall be legible and be stored to minimize damage, prevent loss and provide fast recovery. All documents and records digitally stored should be backed up:

3.1.6.1. Confidentiality. The documents and records deemed confidential by the manufacturer may be marked to alert the competent health authority;

3.1.6.2 Period of retention of documents and records: all records and documents necessary relating to a product should be kept for a period of time equivalent to the useful life time of the product, but in no case for less than two years from the date the distribution thereof.

3.2. Historical record of the product/ Device History Record (DHR)

3.2.1. Each manufacturer shall maintain historical records of products. Each manufacturer shall establish and maintain procedures to ensure that the historical records of products are kept for each batch or series to demonstrate that the products were manufactured according to the master record of the product and the requirements of this Technical Regulation. The historical record of the product should include or refer to the following information:

3.2.1.1. Date of manufacture;

3.2.1.2. Components used;

3.2.1.3. Quantity manufactured;

3.2.1.4. Results of inspections and tests;

3.2.1.5. Parameters of special processes;

3.2.1.6. Quantity released for distribution;

3.2.1.7. Labeling;

3.2.1.8. Identifying serial number or batch production, and

3.2.1.9. Final release of product.

3.3. Records of inspections and tests.

3.3.1. Each manufacturer shall maintain records of the results of inspections and tests set forth when they are directly related to critical quality attributes of the product.

These records should include the acceptance criteria, the results, the equipment / instrument used and date and or electronic signature of the person responsible.

CHAPTER 4 - PROJECT/DESIGN CONTROL AND PRODUCT MASTER RECORD (PMR)

4.1. Project Control

4.1.1. General Instructions Each manufacturer shall establish and maintain procedures to control product design to ensure that the specified requirements for the project are met.

4.1.2. Project planning and development. Each manufacturer shall establish and maintain plans that describe or indicate project and development activities, and the people responsible for each activity. The plans should describe or refer to the activities of project development, including any interaction between the various organizational and technical groups that may have some interface with it. The plans should be evaluated, updated and approved as project development progresses.

4.1.3. Project/Design Input. Each manufacturer shall establish and maintain procedures to ensure that the requirements relating to a product are appropriate and meet its intended use, including the needs of the user and patient and legal requirements and regulations. The procedures shall include a mechanism that allows incomplete requirements, ambiguous or conflicting are identified and treated. The input data of a project should be documented, evaluated and approved by a qualified person designated. The approval requirements, including the date and or electronic signature of the approver should be documented.

4.1.4. Design verification. Each manufacturer shall establish and maintain procedures for verification of product design. The design verification should be performed by a designated and shall ensure that the data meet the project's output to the input data. The results of the design verification, including identification of checked design, verification methods, date and name of the person responsible for the verification, shall be documented in the historical record of the project.

4.1.5. Project/Design Output. Each manufacturer shall define and document the data output of the project in order to allow assessment of conformity to design requirements as input data. The output data of the project shall meet the requirements of the input data and should include acceptance criteria and identify design features that are essential to the intended use of the product. These should be documented, reviewed and approved prior to release.

4.1.6. Project/Design Review. Each manufacturer shall establish and maintain procedures to ensure that the evaluations of the results of projects are planned, conducted and documented in the various stages of project development. The

procedures shall ensure that representatives of all functions directly related to stage of the project that is being reviewed, as well as individuals and experts in related fields required are involved. The results of design review should be documented in the historical record of the project.

4.1.7. Transfer project. Each manufacturer shall establish and maintain procedures to ensure that the product design is correctly translated into production specifications.

4.1.8. Design validation. Each manufacturer shall establish and maintain procedures for validating the product design. The validation of the project should be carried out under predetermined operating conditions on initial production batch or unit. The design validation must ensure that the product meets user needs and indication for use and should include testing of the products in real or simulated conditions of use. The design validation must

include the validation software when appropriate. The results of the design validation, including identification, methods, data and physical or electronic signature of the responsible should be documented in the historical record of the project. Should be conducted stability studies where applicable.

4.1.9. Release project. Each manufacturer shall ensure that the project is not released for production until it is approved by the persons designated for such by the manufacturer. Appointees shall review all records required for the historical record of the project, to ensure it is complete and that the final design is compatible with the approved plans, prior to their release. This release, including date and or electronic signature of the person responsible, must be documented.

4.1.10. Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation, review and approval of design changes before their implementation, including a risk assessment within the risk management process.

4.1.11. Historical record of the project. Each manufacturer shall establish and maintain a historical record of the project for each product. The historical record of the project shall contain or make reference to all records necessary to demonstrate that the project was developed in accordance with the approved design plan and the requirements of this Technical Regulation.

4.2. Product Master Record (PMR)/Device Master Record (DMR)

4.2.1. Each manufacturer shall maintain the product masters records (DMR). The DMR for each type of product should include or refer to the following information:

4.2.1.1. Product specifications, including their designs, composition, formulation, component specifications, design specifications of the software and its source code;

4.2.1.2. Specifications of the production process, including specifications of infrastructure, equipment, methods and instructions for production and environmental specifications of production;

4.2.1.3. Packaging and labeling specifications, including methods and processes used;

4.2.1.4 Procedures for inspection and testing, with their acceptance criteria, and

4.2.1.5. Methods and procedures for installation, maintenance and servicing.

CHAPTER 5 - CONTROLS AND PRODUCTION PROCESS

5.1. General Instructions

5.1.1. Each manufacturer shall design, conduct, control and monitor all production processes to ensure that the product conforms to its specifications. Where can occur any deviation in the product specifications as a result of the manufacturing process, the manufacturer shall establish and maintain procedures to control process that describe any process controls necessary to ensure conformance to specifications. Process controls should include:

5.1.1.1. Documented instructions, standard operating procedures and methods that define and control the manner of production, installation and maintenance;

5.1.1.2. Monitoring and control of process parameters;

5.1.1.3. Compliance with technical standards, codes or standards of reference, and

5.1.1.4. Instructions for process initiation release;

5.1.2. The company's facilities must be properly designed in order to provide the performance of all operations, exchanges or prevent contamination of components, manufacturing materials, intermediate and finished products and ensure proper handling of them, including adequate flow of people.

5.1.3. Environmental Control. Each manufacturer shall provide suitable environmental conditions for production processes in order to prevent contamination or other adverse effects on the product. The correct functioning of the established environmental controls should be monitored, keeping the corresponding records.

5.1.3.1. Cleaning and sanitizing. Each manufacturer shall establish and maintain appropriate procedures for cleaning and sanitizing, as well as a schedule that satisfies the requirements of the specifications of the

manufacturing process. Each manufacturer shall ensure that personnel involved understand these procedures.

5.1.3.2. Health and personal hygiene. Each manufacturer shall ensure that employees and or others who are in contact with the product or your environment is clean, healthy and appropriately dressed for the activity to be performed. Any person who, by medical examination or supervisory observation, appearing to be at a health condition that may affect the product should be removed from operations until it is remedied. Each manufacturer shall instruct its staff to report such conditions to supervisors.

5.1.3.3. Personal habits. Each manufacturer shall limit the consumption of food and drinks at specific locations so as not to affect the production areas.

5.1.3.4. Control of contamination. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment, components, manufacturing materials, intermediate and finished products for cleaning and disinfecting materials, including hazardous substances or contaminants generated by the manufacturing process.

There should be a program of pest control and where chemicals are used, the company must ensure that they do not affect product quality.

5.1.3.5. Trash removal and chemicals sewage. The treatment and disposal of waste, chemical waste and by-products shall occur in accordance with the current laws.

5.1.3.6. Biological safety standards should be observed in cases where there are biological risk.

5.1.4. Worker occupational health. Each manufacturer shall ensure compliance with applicable standards related to the occupational health of workers, including the use of personal protective equipment for the same, which is consistent with the work processes performed.

5.1.5. Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process are suitable for the intended use and properly designed, constructed and installed to facilitate maintenance, adjustments, cleaning and use.

5.1.5.1. Maintenance schedule. Each manufacturer shall establish and maintain a schedule for maintenance, adjustments and, when appropriate, cleaning equipment, to ensure that all manufacturing specifications are being met. The maintenance program should be easily accessible to maintenance personnel and equipment use. Should be made a record of maintenance activities to the date of realization and identification of persons responsible.

5.1.5.2. Adjustments. Each manufacturer shall ensure that any inherent limitations or acceptable tolerances are posted in a conspicuous place at or

near the equipment requiring periodic adjustments or are readily available to the personnel in charge of these adjustments.

5.1.5.3. Manufacturing materials. Each manufacturer must establish and maintain procedures for the use and removal manufacturing materials, to ensure that such materials be removed from the product or limited to a specified amount that does not adversely affect the quality of the product.

5.1.6. Special Processes shall be conducted in accordance with procedures and guidelines established to ensure conformance to specifications. Critical parameters should be monitored and recorded in the historical record of product.

5.2. Controls packaging, labeling and instructions for use

5.2.1. Product packaging. Each manufacturer shall establish procedures for the packaging of goods so as to protect the product from deterioration, damage or contamination during processing steps, storage, handling and distribution.

5.2.2. Product labeling

5.2.2.1. Each manufacturer shall establish and maintain procedures to ensure the integrity and avoid accidental mixing of labels, instructions for use, packaging materials, and identification labels.

5.2.2.2. Each manufacturer shall ensure that the labels are designed, printed and, if applicable, applied to remain legible and attached to the product during processing steps, storage, handling and use.

5.2.2.3. Inspection of the labels and instructions for use. The labels and instructions for use shall not be released for use until an authorized person has reviewed its compliance regarding information contained therein. The approval, including date, name and physical or electronic signature of the person responsible, must be documented in the historical record of the product.

5.3. Inspection and testing

5.3.1. General instructions. Each manufacturer shall establish and maintain procedures of inspection, testing or other means of verification to ensure compliance with the requirements specified in the full chain of manufacturing. The results of the activities of acceptance upon receipt of components and manufacturing materials as well as intermediate production stages and final acceptance of the finished product shall be documented, including its completion (acceptance or rejection).

5.3.2. The authority and responsibility for such activities shall be defined by the manufacturer.

5.3.3. Components and manufacturing materials received, as well as components, intermediate products, and returned products should not be used or processed until it is checked for conformance to requirements. Each manufacturer shall establish and maintain procedures for retaining components, manufacturing materials, intermediates, and products returned until the inspections, tests, or other established checks have been completed and documented.

5.3.4. The finished products should not be freed until the activities specified in the PMR/DMR have been completed and until the documentation and associated data have been reviewed by a designated person to ensure that all acceptance criteria have been met. The release, including the date and or electronic signature of the person responsible, must be documented.

5.4. Inspection, test and measuring equipment.

5.4.1. Each manufacturer shall ensure that all measuring and test equipment, including mechanical equipment, automated or electronic, is suitable for the purposes for which it is intended and be able to produce valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected and controlled. The measuring equipment shall be identified to enable the calibration status to be determined.

5.4.2. Calibration. Each manufacturer shall establish and maintain calibration procedures that include specific guidelines and limits of precision and accuracy, as well as prescriptions for corrective action when the limits of precision and accuracy are not achieved.

Calibration should be performed by personnel who have education, training, practice and experience needed.

5.4.3. Calibration standards. Each manufacturer shall establish and maintain calibration standards for measuring equipment that are traceable to national or international standards officers. If there is no applicable standard is available, the manufacturer shall establish and maintain its own pattern.

5.4.4. Calibration records. Each manufacturer shall ensure that records are kept of the dates of calibration measurements obtained, the employee in charge of this task and the next date for this operation. Records shall be kept by the manufacturer and should be available for staff using this equipment and those responsible for the same calibration.

5.4.5. Maintenance. Each manufacturer shall establish and maintain procedures to ensure that the handling, preservation and care of test, inspection and measurement equipment to be made in order to preserve its accuracy and suitability.

5.4.6. Facilities. Each manufacturer shall protect facilities and inspection, test and measurement equipment, including test hardware and software, from adjustments that would invalidate the calibration.

5.4.7. The manufacturer shall establish procedures to assess the impact of the previous measuring results when non-compliances observed in test and measurement equipment. The result of the assessment should be documented.

5.5. Validation

5.5.1. Special processes must be validated according to previously established protocols. The results of validations, including the date and identification of the person responsible for its approval, shall be recorded.

5.5.2. Analytical methods, auxiliary systems support process or environmental control, automated information systems and software that may adversely affect the quality of the product or the quality system must be validated.

5.5.3. The manufacturer shall establish procedures to periodically check your processes, analytical methods, auxiliary support systems for process control or environment, information systems and automated software validated and, where applicable, establish the frequency for revalidation.

5.6. Change Control.

The manufacturer shall establish a procedure to control changes in order to track changes in auxiliary systems, software, equipment, processes, methods or other changes that may affect product quality, including a risk assessment within the risk management process .

5.6.1. The procedure should describe the actions to be taken, including, when appropriate, the need for re-qualification or re-validation.

5.6.2. Changes should be formally requested, documented and approved before implementation.

CHAPTER 6 - HANDLING, STORAGE, DISTRIBUTION AND TRACKING

6.1. Handling

6.1.1. Each manufacturer shall establish and maintain procedures to ensure that inversions (changes), damage, deterioration or other adverse events affecting the components, manufacturing materials, intermediate products, finished products and samples for quality control does not occur during any stage of the handling.

6.1.2. Each manufacturer shall establish and maintain procedures to identify the conformity of components, manufacturing materials, intermediate products and finished products to ensure that only those duly approved, are used or distributed.

6.1.3. The procedures must ensure that when the quality or condition of the use of a suitable component manufacturing material, intermediate product or finished product can deteriorate over time, they are not used or distributed.

6.1.4. The procedures shall ensure that components, manufacturing materials, intermediate or finished products closer to the expiration are distributed or used in the first place, and that one out-date are not distributed or used.

6.2. Storage

6.2.1. Each manufacturer shall establish and maintain procedures for identifying components, manufacturing materials, intermediate products, finished products and samples for quality control in order to prevent inversions (exchanges). These should be stored in physical and environmental conditions that prevent damage, deterioration or other adverse effects during the period in which remain stored.

6.3. Distribution

6.3.1. Each manufacturer shall maintain distribution records which include or refer to:

6.3.1.1. Name and address of the consignee;

6.3.1.2. Identification and quantity of products shipped with shipment date, and

6.3.1.3. Any numerical control used for traceability.

6.4. Identification and traceability

6.4.1. Each manufacturer shall establish and maintain procedures for the identification of components, manufacturing materials, intermediates and finished products during all phases of storage, production, distribution and installation to avoid confusion and to ensure correct order fulfillment.

6.4.2. Each manufacturer shall identify each unit, lot or batch of products with a serial number or lot. This identification shall be recorded in the historical record of the product.

6.5. Components and non-compliant products

6.5.1. Each manufacturer shall establish and maintain procedures to ensure that components, manufacturing materials, intermediate products, finished

products and returned products that do not comply with the requirements are not used or installed inadvertently. The procedures shall include requirements for the identification, documentation, evaluation, segregation and disposition about components, manufacturing materials, intermediates and finished products not complying.

Assessment of non-compliance should include the need for investigation and notification to individuals and or organizations involved in non-compliance.

The results of evaluations and any investigation should be recorded.

6.5.2. Responsibility for review and authority for disposition about components, manufacturing materials, intermediate products, finished products and returned nonconforming must be defined. The review process and disposition must be described in established procedure. The disposition should be documented and should be kept record of justification and physical or electronic signature (s) responsible (s) for the same.

In case of a use permit, the decision should be based on risk assessment technically justifiable.

6.5.3. Each manufacturer shall establish and maintain procedures for rework, reinspection and revaluation of intermediate or finished product after rework, to ensure that they meet original specifications. Activities related to rework and reevaluation of the product, including the same problems from the rework should be documented in the historical record of product.

SECTION 7 - PREVENTIVE AND CORRECTIVE ACTIONS

7.1. Corrective and preventive actions.

7.1.1. Each manufacturer shall establish and maintain procedures

for:

7.1.1.1. Analyzing processes, work operations, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconformities relating to product, process or quality system. Where applicable, the analysis should be based on valid statistical technique to detect recurring quality problems;

7.1.1.2. Investigating the cause of nonconformities relating to product, process and quality system;

7.1.1.3. Identify and perform the necessary actions to prevent the occurrence, fix what happened and prevent recurrence of non-conformities;

7.1.1.4. Verify or validate the effectiveness of the corrective action and ensure that it does not adversely affect the product. For this purpose, any changes

made, where applicable, shall observe the following change control and validation protocols established;

7.1.1.5. Record activities related to corrective and preventive actions;

7.1.1.6. Ensure that information about quality problems or nonconforming product are properly disseminated to those directly involved in the maintenance of product quality and to prevent such problems from occurring;

7.1.1.7. Submitting relevant information on identified quality problems and preventive and corrective actions to executive management to knowledge and monitoring, as well as the competent health authority, where applicable;

7.1.1.8. Determine product recalls and other field actions that are relevant in the case of products already distributed.

7.2. Complaints management.

7.2.1. Each manufacturer shall establish and maintain procedures to receive, examine, evaluate, investigate and file complaints. Such procedures shall ensure that:

7.2.1.1. Complaints are received, documented, examined, evaluated, investigated and filed by a formally designated unit;

7.2.1.2. Where applicable, the complaints are notified to the competent health authority;

7.2.1.3. Complaints are examined to see if an investigation is necessary. When an investigation is not done, the unit shall maintain a record that includes the reason why the investigation was not conducted and the name of the responsible decision not to investigate;

7.2.1.4. Each manufacturer shall examine, evaluate and investigate all complaints involving possible non-conformity of the product. Any claim for death, injury, or threat to public health should be immediately reviewed, evaluated and investigated.

7.2.1.5. When an investigation is made, it should be kept a record that includes:

7.2.1.5.1. Name of product;

7.2.1.5.2. Date of receipt of the complaint;

7.2.1.5.3. Any number of control used;

7.2.1.5.4. Name, address and telephone number of the complainant;

7.2.1.5.5. Nature of the complaint and

7.2.1.5.6. Data and research results including actions taken.

7.3. Quality audit.

7.3.1. Each manufacturer shall conduct and document quality audits to assess compliance with quality system requirements.

7.3.2. Quality audits must be conducted by persons trained proven, according to the audit procedures established but not having direct responsibility for the matters being audited.

7.3.3. Those responsible for the areas audited must be notified of the non-compliances identified.

CHAPTER 8 - INSTALLATION AND SERVICE

8.1. Installation.

Each manufacturer shall establish and maintain appropriate procedures and instructions for proper installation of the products. When the manufacturer or his authorized representative installs a product, it should check if this works as criteria. The results of this check must be registered. The manufacturer shall ensure that the installation instructions and procedures are distributed with the product or that otherwise are available to the responsible for product installation.

8.2. Technical Assistance.

Each manufacturer shall establish and maintain procedures to ensure that the finished products under technical assistance, either by the manufacturer or its representative, meet the specifications.

8.2.1. Records service. Each manufacturer shall establish and maintain procedures to ensure that technical assistance records are maintained and identify:

8.2.1.1. Product service object;

8.2.1.2. Control number used;

8.2.1.3. Date of the service;

8.2.1.4. Identification of the service provider;

8.2.1.5. Description of service performed, and

8.2.1.6. Results of inspections and tests for approval service.

8.2.2. Each manufacturer shall periodically review the records of technical assistance. In cases where the analysis fails to identify trends hazards or records involving death or serious injury should be initiated corrective action / preventive accordance with the requirements of this Technical Regulation.

CHAPTER 9 - TECHNICAL STATISTICS

9.1. Each manufacturer shall establish and maintain procedures for identifying valid statistical techniques to verify the performance of the quality system and process capability to meet established specifications.

9.2. Sampling plans must be in writing and based on valid statistical logic. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are appropriate for the intended use and are reviewed regularly. A review of sampling plans should consider the occurrence of nonconformities, product quality audit reports, complaints and other indicators.

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