YY 0033-2000Good manufacturing practice for sterile medical devices (English PDF)

1 Scope

This standard specifies the general requirements for production and quality management of sterile medical devices and their components.

The production of primary packaging materials for sterile medical devices shall also meet the requirements of this standard.

2 Normative references

The provisions of the following standards constitute provisions of this standard through reference in this standard. The editions indicated were valid at the time of publication. All standards are subject to revision, and parties using this standard should investigate the possibility of applying the most recent editions of the standards indicated below.

GB/T 6583-1994, Quality management and quality assurance - Vocabulary

GB/T 16292-1996, Testing method of airborne particles in clean rooms (zones) of the pharmaceutical industry

GB/T 16293-1996, Testing method of airborne microbes in clean rooms (zones) of the pharmaceutical industry

GB/T 16294-1996, Testing method of settling microbes in clean rooms (zones) of the pharmaceutical industry

YY/T 0313-1998, Packaging, labelling, transportation and storage of medical polymer products

JGJ 71-1990, Code for construction and acceptance of clean rooms

3 Definitions

For the purposes of this standard, the definitions given in GB/T 6583 and YY/T 0313 and the following apply.

3.1 lot: a defined quantity of a product of uniform properties and quality, manufactured under essentially constant conditions.

3.2 lot number: a distinctive combination of digits, or of letters and digits, that identifies a lot and allows the production history of that lot to be traced and reviewed.

3.3 production lot: a defined quantity of a product of uniform properties and quality, manufactured continuously by the same process within a given period. Note: where products are manufactured continuously and a production lot is difficult to define, the output of one working day or one shift is usually taken as the production lot for management purposes.

3.4 sterilization lot: a defined quantity of a product sterilized to the same sterility level, in the same sterilizer and by the same process.

3.5 sterilization: a validated process used to render a product free from viable microorganisms of any kind.

3.6 sterile: free from viable microorganisms.

4 Quality system

Manufacturers of sterile medical devices shall establish and implement an effective quality management system, establish complete quality system documentation, and carry out management reviews and internal audits at regular intervals.

4.1 Quality policy: the quality policy shall be issued as a document by the top management of the enterprise. Quality objectives shall be established, and the quality policy understood and implemented, at the relevant functions and levels.

4.3.1 The enterprise shall appoint management and technical staff at all levels and of all types, with professional knowledge, production experience and organizational ability suited to the production of sterile medical devices and familiar with the national regulations on the supervision and control of medical devices, to be responsible for organizing production and quality management.

4.3.4 The heads of the production management and quality management departments shall have professional knowledge and management experience relevant to their duties, and shall be able to judge and deal correctly with practical problems arising in the production and quality management of sterile medical devices.

5 Production environment, facilities and layout

5.1 Site and factory: manufacturers of sterile medical devices shall have a clean production environment. The grounds, roads and transport within the factory shall not contaminate the production of sterile medical devices.

5.1.1 The factory shall be located in an area with good sanitary conditions, fresh air, low concentrations of dust and airborne microorganisms, a good natural environment and no harmful gases.

5.1.2 The site shall be remote from railways, ports, airports and traffic arteries, and from factories, storage yards and dumps that emit large amounts of dust and harmful gases, and from places with serious air or water pollution, vibration or noise. Clean rooms shall be at least 50 m from main municipal traffic routes.

5.2 Production facilities: according to the production process and product quality requirements, production facilities are divided into general production areas and clean areas, and shall be laid out according to the process flow and the required air cleanliness class.

5.3.2 Personnel shall undergo purification before entering the clean rooms (zones) used for the production of sterile medical devices or for aseptic operations. Annex D gives the general procedure for entering and leaving clean rooms (zones).

5.4.3 Outer packaging used for transport and storage, and packaging materials that shed dust or fibres, shall not be taken into clean rooms (zones). Primary packaging materials in direct contact with the product shall have at least two layers and shall be effectively protected against contamination during transport, storage and handling.