Medical device manufacturers should strengthen the management of the quality of process water in accordance with the requirements of the "Code for the Quality Management of Medical Device Manufacturing" to ensure that the products exposed to process water meet the quality requirements and that the production environment and its auxiliary functions are effectively controlled.
I. Scope of application
The process water referred to in this guide mainly refers to the purified water and water for injection in accordance with the provisions of the "Chinese People's **** and the National Pharmacopoeia", but also includes the sterilized water for injection, in vitro diagnostic reagents, purified water, hemodialysis and related therapeutic water, water for analytical laboratories, etc.. Process water can be used as a component of products, and can be used for the cleaning of finished products, outsourced parts or semi-finished products, internal packaging, testing of products, cleaning of clean environments, facilities and equipments, and working clothes, hand-washing of personnel, and configuration of reagents for testing.
This guideline applies to the management of process water for medical device manufacturers, medical device manufacturers should strengthen the prevention and control of risk measures, in accordance with the provisions of the relevant technical standards, to ensure that the quality of process water meets the product quality requirements.
Second, the quality management requirements
(a) should be based on the process of water related regulations and technical standards, combined with the characteristics of the products produced and the use of process water to specify the type of process water required to ensure that the water requirements in line with the regulations and relevant standards. Sterilization of water for injection should have a drug approval number.
(B) should be developed to manage the process of water, process water preparation methods, the use of process, inspection and storage requirements, etc., the water system operating procedures, pipe cleaning and disinfection methods, as well as daily maintenance of the water system, validation, etc., and save the relevant records.
(C) should be analyzed in conjunction with the actual production needs of process water consumption, preparation of water consumption analysis report, determine the amount of water consumption, and regularly review and analyze water consumption.
(D) should be based on the type and amount of process water to determine the appropriate water production system, to ensure that the water production system is equipped with facilities suitable for the preparation of process water, piping and storage tanks do not cause pollution and impact on the process water, and save the water production system piping design drawings, water production system instruction manuals, process water preparation flow charts, technical documents and other archival materials, and to strengthen the quality audit of water production system manufacturers. System manufacturers to strengthen the quality of the audit.
Self-configuration of purified water system should be purified water shall not be purchased; water for injection can be purchased when the amount of water is small.
(E) should be installed on the water system, operation and performance verification, to ensure that the water system continues to produce a stable water system meets the standards, suitable for the production of products required for the process water, and save the water system verification plans, programs, reports, and re-verification of relevant technical information.
(F) should determine the form of transmission of process water, the amount of larger should be transported through the pipeline to the clean room (area) of the water point. Transported through the pipeline, should be on the process of water type, flow direction for identification.
(VII) should be prepared after the use of process water and storage requirements to ensure that its quality meets the requirements, will not cause contamination of medical device products and clean room (area).
(VIII) should determine the process water sampling points, the development of sampling point distribution map, at least should include the total water supply and return to the mouth of the total sampling points, and to ensure that the sampling point set reasonable.
(ix) should be developed process water testing procedures, to determine the process of water testing projects, methods and test cycles, in accordance with regulations and relevant standards for process water indicators for regular testing, and save process water testing records. For regulations and standards have not been clearly specified, the enterprise should be on the water quality inspection of the project, the inspection cycle for verification and confirmation.
(J) should have physical and chemical indicators, microbiological limits of the test capacity and conditions, save the process water test reagents preparation and use of records.
(k) should be on the water system cleaning, disinfection methods, to determine the appropriate disinfection method and frequency, and be verified. Cleaning, disinfection methods shall not contaminate water quality, shall not have an impact on equipment, piping, and save the pipeline cleaning and disinfection, verification and trend analysis and evaluation records.
(xii) should be regular maintenance of the water system. Involving the need to measure, calibrate the instrumentation, apparatus should be measured regularly, calibration, marking obvious, and save the water production system instrumentation, apparatus measurement, calibration certificate. Commissioned water system manufacturers for equipment maintenance, cleaning, disinfection, should be commissioned to sign an agreement with the water system manufacturers, technical requirements, quality requirements, etc., to clarify the quality of both parties to bear the responsibility.
(xiii) should determine the process of water management of the responsible departments and job personnel, job personnel should be familiar with the relevant laws and regulations, with the position of appropriate professional knowledge and work experience, and save the relevant personnel appointment letter, induction certificate and training records.
(xiv) the procurement of a small amount of water for injection and sterilized water for injection, should focus on checking the qualifications of the supplier, process water qualification, water quality testing reports and / or verification reports, delivery carrier material, process water storage conditions, storage time requirements, etc., to ensure that the purchased process water to meet the requirements of product production.