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“Quality Management Guidance for Process Water of Medical Device” Interpretation

from CIRS by
In order to guide medical device manufacturer to control and manage the quality of process water, CFDA has formulated the Quality Management Guidance for Process Water of Medical Device according to Administrative Measures for the Supervision of Medical Device Manufacturing, Good Manufacturing Practice for Medical Device and related appendixes, and issued on Jan 26th, 2016.

What is the process water?
Process water refers to the generic name of the water which is used in product manufacturing process, including drinking water, purified water, water for injection, sterile water for injection, water for heamodialysis and related therapiea, etc.

What is the function of process water?
Process water can be used for being a component of product, preparation of reagents, cleaning the packaging for semi-finished products and spare parts, finished products, product testing, and so on.

How to control the quality of process water?

  1. Shall determine the category of process water on the basis of relevant laws, regulation and technical standards of process water, and combine with the product feature and intend use of process water.
  2. Shall determine the appropriate water system according to the category and quantity of process water, to ensure the function of water system and preparation facilities can adapt to the preparation of process water.
  3. Shall determine the transfer form of process water. If the water is transferred through the pipeline, you shall identify the category and flow direction process water.
  4. Shall ensure the materials of tank and pipeline which contact process water directly do not cause pollution and affection to process water. The installation shall be designed to avoid dead ends and blind side, to protect from microorganism breeding and contamination.
  5. Shall conduct verification and validation for water system installation, running and performance, etc., to ensure the water system can be sustained and stable, the process water can meet the requirements of relevant standards. And save the technical documents of verification plan, protocol and report, as well as validation documents.
  6. Shall save the archival data, such as design drawing of water system, operation instruction, flow chart of process water preparation, technical files, etc.
  7. Shall determine the responsible department and person in the post for process water preparation and testing. The person in the post shall be acquainted with relevant laws and regulations, and have the appropriate professional knowledge and work experience. Save the training records.
  8. Shall formulated the administration regulation for process water, which involved in process water preparation, testing, lifetime, water system operation, tank and pipeline cleaning, and so on. And save the correlated activation records.
  9. Shall determine the sampling points, and formulate the sampling point distributing charts. Shall include the total outlet and inlet, and farthest sampling point of pipeline at least, to ensure the sampling points are set reasonably.
  10. Shall formulate the testing procedure of process water, and determine the test items, methods and testing periods. Manufacturer shall test the process water regularly according to relevant regulations and standards, and save the testing report. If there is no provision for process water, manufacturer shall verify and validate the test item and testing periods.
  11. Shall have the testing ability and condition for physicochemical item and microbial limit, and save the use records of reagent preparation for process water.
  12. Shall determine and verify the disinfection method and frequency for process water. Cleaning and disinfection methods shall not cause pollution to water, and affection on tank and pipeline. Save the clean and disinfection record and verification record.
  13. Shall conduct regular maintenance for water system, which involved in instruments and tools measurement and calibration. Save the measurement and calibration certificate of instruments and tools. If manufacturer entrusts other organization to maintain, clean and disinfect, shall sign an agreement with organization, stipulate the technical requirement and quality requirement, etc., define the quality responsibility borne by both organizations, and save relevant records.
  14. Shall analyze the process water quality regularly according to actual production need, formulate analysis report, and save relevant record.
  15. If the water for injection and sterile water for injection are procured from other enterprise (supplier), manufacturer can manage the supplier according to the relevant requirements of Supplier Review Guidelines for Medical Device Manufacturer (CFDA, No 1. 2015). Shall focus on examining supplier qualification, testing report and/or verification report of process water, material of transport carrier, storage condition and time.
If you need the English version of Supplier Review Guidelines for Medical Device Manufacturer, please contact us.

Ms. Windy Jin,
Medical Device Legislation Compliance Deportment, CIRS China;
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Email: Windy@cirs-group.com

  

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