YY 0033-2000 PDF English
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| YY 0033-2000 | English | 125 |
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Good manufacture practice for sterile medical devices
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| YY/T 0033-1990 | English | 359 |
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(Sterile medical equipment production management practices)
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YY 0033-2000: Good manufacture practice for sterile medical devices---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0033-2000
YY
C 30
Record No. 0854-2001
Medical Industry Standard
of the People��s Republic of China
Replacing YY/T 0033-1990
Good manufacture practice for
sterile medical devices
Issued on. AUGUST 18, 2000
Implemented on. SEPTEMBER 15, 2009
Issued by. State Drug Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Quoted standards... 5
3 Definitions... 6
4 Quality system... 7
5 Production environment, facility and layout... 9
6 Facility and work clothes... 12
7 Purchasing and material management... 13
8 Document... 14
9 Quality management... 15
10 Production process management... 16
11 Hygienic management... 18
12 Product sales and customer service... 19
Annex A... 20
Annex B... 21
Annex C... 23
Annex D... 24
Annex E... 25
Annex F... 26
1 Scope
This Standard specifies the general requirements of production and quality
management for sterile medical devices and the components and parts.
Production of primary package material of sterile medical devices shall also need to
meet the requirements of this Standard.
2 Quoted standards
The provisions in following standards become the provisions of this Standard through
reference in this Standard. The following standards are effective when issuing this
Standard. All standards would be revised, parties who use this Standard shall discuss
the possibility of using the newest version of the following standards.
GB/T 6583-1994 Quality management and quality assurance �� Terms
GB/T 16292-1996 Testing method of airborne particles in clean room (area) of
medical industry
GB/T 16293-1996 Testing method of airborne microbe in clean room (area) of
medical industry
GB/T 16294-1996 Testing method of settling microbe in clean room (area) of
medical industry
YY/T 0313-1998 Package, labeling, transportation and storage of medical
polymer
JGJ 71-1990 Construction and acceptance specification of clean room
3 Definitions
This Standard uses the definitions in GB/T 6583 and YY/T 0313 AND the following
definitions.
3.1 Lot
A certain quantity of a product that are with same property and quality manufactured
under relatively stable condition.
3.2 Lot number
A set of ��digits�� or ��letters and digits�� that are used to identify ��lot��. Base on that, it may
trace and review the production history of this lot of products.
3.3 Production lot
In a period, a certain quantity of a product that are with same property and quality, and
continually manufactured under a same process.
Note. To some continually manufactured products, sometimes it��s difficult to determine the production
lot. For the needs of management, usually it may take the products manufactured in one working day
or a shift as the production lot.
3.4 Sterilization lot
In a same sterilized cabinet, a certain quantity of a product that are with same
sterilization level and sterilized under same process.
3.5 Sterilization
A validated process used to make products free of living microbiology in any shape or
form.
3.6 Sterile
There is no living microbiology on the medical device.
4 Quality system
Sterile medical device manufacturing enterprise shall establish and implement the
effective quality management system, build a complete document of quality
management system, and regularly conduct management review and internal review.
4.1 Quality policy
Quality policy shall be issued in document by the top management of the enterprise.
Quality objectives, understanding and implement of quality policy shall be established
at relevant functions and levels.
4.2 Organization
4.3 Personnel
4.3.1 Enterprise shall assign management and technical staffs of all levels and types
who have professional knowledge, production experience, and organizing ability
compatible with sterile medical device production and be familiar with relevant
national provisions for supervision and control of medical device, and who are
responsible for organizing production and quality management.
4.3.4 Responsible person of departments of production management and quality
management shall have professional knowledge and management experience
relevant to his job; and have ability to make correct judgment and handling to practical
problems during sterile medical device production and quality management.
5 Production environment, facility and layout
5.1 Location and factory
Sterile medical device manufacturing enterprise must have clean production
environment. The ground, road, and handling in factory shall not pollute the
production of sterile medical device.
5.1.1 Location of factory shall be chosen at areas with good sanitary condition, fresh
air, low concentration of dust and microbe in air, good natural environment and free
from hazardous gas.
5.1.2 Location shall be far from the railway, port, airport, traffic artery, and factory, silo,
stockyard that emit a lot of dust and hazardous gas and where have serious air
pollution, water pollution, vibration or noise interference. Clean room shall not be less
than 50m from municipal transport corridors.
5.2 Production facility
According to the production process and product quality, production facility is divided
into general production area and clean area. Facilities shall be reasonably designed
according to production process flow and required air cleanliness classification.
5.2.1 General production area
General production shall be reasonably designed with good light and ventilation to
meet production requirements.
5.2.2 Clean area
5.2.2.1 Besides meeting the requirements of 5.2.1, clean area shall also be equipped
5.2.2.3 External window of personnel purification room and clean room (area) shall be
double-window with good sealability. Ceiling of clean room (area) and the channel,
wind gap and ceiling or wall of personnel purification room (area) shall be sealed.
5.2.2.4 Doors of clean room (area) shall be of effective sealed, and to be opened
toward higher cleanliness direction.
5.2.2.5 Emergency door shall be set in clean room (area), and to be opened toward
the escape exit, which shall be sealed well in normal time, and easy to open when
emergency. The relief passage shall not be blocked.
5.2.2.6 Clean room (area) shall be reasonably designed according to process flow,
and separate the direction of personnel flow and material flow.
5.2.2.7 Water and electricity lines in clean room (area) shall be placed under the wall
surface. Mouth of the electricity and gas pipelines, junctions with wall and various
electric appliances installed on wall shall be of effective sealed.
5.3 Personnel purification
5.3.1 Personnel purification rooms shall include room for changing footwear, room for
keeping overall, rest room, room for wearing clean work clothes, room for air lock or
room for air shower, etc.
5.3.2 Personnel shall be purified before entering into sterile medical device production
clean room (area) or sterile operation clean room (area). Annex D provides the
general procedure in and out of clean room (area).
5.3.3 At the room for changing footwear in personnel purification area, it shall pay
attention to avoid cross contamination of two kinds of footwear. There shall have
obvious boundary to limit the cross-over between the outside-footwear and the
footwear to be changed. Slippers are forbidden in clean room (area).
5.4 Material purification
5.4.1 Clean measures shall be taken to material entering into clean production area,
such as room for taking off external package and dust chamber.
5.4.2 It shall install air locks and double delivery windows between material
purification room and clean room (area) to deliver materials and other goods.
5.4.3 External package used for material transportation and storage, and package
material with caducous dust and fiber shall not be taken into clean room (area).
Primary package material directly contacted with product shall be with at least two
layers and with efficient anti-pollution during transportation, storage, and handling.
5.5 Process layout
6 Facility and work clothes
6.1 Design and shape of facility shall meet production requirements, with reasonable
layout; and are easy to operate, repair, and maintain.
6.2 Facility and work clothes chosen in clean room (area) shall have measures of
anti-dust, anti-pollution, and with simple structure, low noise, non-dust during working.
Surface of facility, work clothes, and channel shall be smooth, even, non-shedding
particles, easy to be cleaned and sterilized, and could reduce pollution.
6.3 Surface of facility, work clothes and channel directly contacted with material and
product shall be innocuous, corrosion-resistant, non-blind angle, easy to be cleaned
and sterilized, non-chemical reaction or accretion with material or product.
6.7 It shall have equipment of preparing process water. The ability of preparing water
of which shall meet production requirement. Process water shall be periodically
inspected according to standard. Storage and delivery channel of process water shall
be stainless steel or other innocuous material, and be cleaned, sterilized periodically.
6.8 Scope and accuracy of apparatus, instrument, gauge, weighing machine, etc.
used for production and inspection shall meet the requirements of production and
quality inspection, have obvious status marking and be detected and verified
periodically.
7 Purchasing and material management
7.1 Enterprise shall have regulations to control purchasing process, establish
purchasing documents such as purchasing plan, contract, and technical protocol. It
clearly provides the quality requirements of purchased material to ensure the standard
is met, and shall keep the copy of purchasing documents.
7.2 Enterprise shall evaluate suppliers, investigate and analyse their production
environment (especially when purification is required), quality assurance, certificate,
and reputation whether it meets national regulations. Before placing large order,
enterprise shall trial out in a small amount, and then put into production after qualified
inspection. It shall have relatively stable suppliers. It shall establish and keep
suppliers�� quality record.
7.3 Purchased material shall be placed at area with obvious marking of ��waiting for
inspection��, and it can only be released to warehouse after inspected qualified by
quality inspection department.
7.6 Labeling, conformity certificate, operation instructions, and small package shall be
specially kept. The distribution, usage, and destroy shall be recorded.
7.7 Special quarantine measures shall be taken to inflammable and explosive
materials.
8 Document
8.1 Quality system document
8.1.1 Enterprise shall establish the quality manual describing their quality
management document.
8.1.2 Enterprise shall establish procedure document, management document, and
regulations required by this Standard, and effectively implement them.
Note 1.GB/T 19001 and YY/T 0287 OR GB/T 19002 and YY/T 0288 stipulate the requirements of
quality management system documents.
8.2 Technical document
Enterprise shall have technical documents to guide the product manufacturing and
usage of products, which shall be unified, complete, and correct.
8.3 Document control
8.3.1 Enterprise shall establish procedures of document control to control all
documents (including quality manual, procedure documents, specifications, drawings,
standards, process documents or work instructions, etc.) related to quality.
Documents shall be approved before issuing.
8.3.2 Quality record document shall be established by written procedure and be
controlled. It specifies the marks, storage, searching, protection, keeping time, and
disposal of quality record.
9 Quality management
9.1 Enterprise shall have quality management department that is directly leaded by
top management. The responsible person shall meet the requirements of 4.3.4.
9.2 Quality management department shall be staffed with a certain number of quality
management and inspection personnel, and equipped with physical, chemical, and
biological labs and inspection apparatus and instruments compatible with the
production scale, type, and inspection requirements of sterile medical device.
9.3 Responsibility and authority of quality management department.
9.4 Quality management department shall perform receiving inspection and
verification, process inspection, and product final inspection according to provisions;
and issue inspection record and report. The record and/or report shall be signed by
inspector and responsible person who releases the products.
9.5 According to provisions, quality management department shall conduct sampling,
which shall be representative.
9.6 Quality management department shall evaluate suppliers together with other
related departments.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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