Decree 218 Annex 2 Good Manufacturing Practice Guidelines For Onsite Inspection Of Sterile Medical Devices


Annex 2
Good Manufacturing Practice for Medical
Guidelines for On – Site Inspection of Sterile
Medical Devices
Chapter Terms Content
Institutions and
Should establish the management organization that is compatible with
production of medical device and develop organizational charts.
Check whether there are an organization chart of the enterprise in
the quality manual and whether the relationship between the various
departments is clear.
Should clarify the responsibilities and authority of various departments,
and specify quality management functions.
Check whether the quality manual, procedure documents and
relevant files of the enterprise specify the duties and authorities of all
departments; whether the quality management department can
independently perform the functions, and check whether the
documents of the quality management department clearly specify it
has the right to make decision about the issues related to product
The head of quality management and the head of production should not
be the same person.
Check the company’s appointment documents or authorization
documents and verify whether they are consistent with the
authorization based on the records of the relevant production, testing
and other duty fulfillment.
1.2.1 The person in charge of the enterprise is the main person responsible for
the quality of the medical device products.
The person in charge of the enterprise shall organize the preparation of
enterprise quality policy and quality objectives.
Check the development process and approval personnel for the
quality policy and quality objectives.
The person in charge of the enterprise shall guarantee human resources,
infrastructure and work environment required for the effective operation
of the quality management system.
1.2.4 The person in charge of the enterprise shall organize the implementation
of management review, regularly evaluate the operation of quality
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Chapter Terms Content
management system and continuously conduct improvement.
Check the management review documents and records to verify
whether the person in charge of the organization has organized the
management review.
*1.2.5 The person in charge of the enterprise shall organize the production in
accordance with the requirements of laws, regulations and rules.
The person in charge of the enterprise shall determine a management
Check the appointment file for the management representative.
The management representative is responsible for establishing,
implementing and maintaining the quality management system, reporting
on the operation of the quality management system and improving the
needs, and improving the awareness of employees in compliance with
laws, regulations and customer requirements.
Check whether the above duties are clearly defined. Check the
relevant records of the operation and improvement of the quality
management system reported by the management representative.
The person in charge of technical, production and quality management
department should be familiar with the relevant laws and regulations of
medical device, have practical experience in quality management, and
have the ability to make the correct judgment and treatment on the actual
problems in production management and quality management.
Check the qualification requirements of the relevant department
heads, whether the professional knowledge, work skills, work
experience have been specified; check the assessment evaluation
records, combined with on-site inquiries, to determine whether they
can meet the requirements.
Should have technical personnel, managers and operators appropriate for
production of products.
Check the eligibility requirements of the relevant personnel.
Should have the corresponding quality inspection departments or
full-time inspectors.
Check whether the confirmation of organization chart, department
responsibility requirements, post staff appointment and other
documents meets the requirements.
Personnel who are engaged in the work affecting the quality of products
should be trained in accordance with their job requirements, and should
have relevant theoretical knowledge and practical skills.
The positions that affect the quality of the medical device should be
identified and the expertise level (including academic requirements),
work skills, and work experience for these positions must be
specified. Check whether the training content, training records and
assessment records can meet the requirements.
The personnel engaged in the production, technical and quality
management of the implanted medical device of animal source and the
allogeneic medical device should have the corresponding knowledge of
biology, biochemistry, microbiology, medicine and immunology, and
have the corresponding practical experience to ensure their ability to
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Chapter Terms Content
perform corresponding duties in production and quality management.
Check whether the enterprise’s appointment requirements, academic
certificates or training materials for relevant positions can meet the
Personnel who temporarily enter into the clean room (area) should be
instructed and supervised.
Check whether relevant documents have been identified and whether
the enterprise have specified how to instruct and supervise personnel
who temporarily enter the clean room (including visitors) when they
enter or leave clean area.
Should establish cleanness requirements for personnel and hygiene rules
for those who work in the clean room (area).
Check whether the hygiene rules of the personnel have specifies the
cleanness, entry/exit procedures, and wearing of clean clothes.
Personnel who enter into the clean room (area) should be purified in
accordance with the procedures, and wear work caps, masks, clean
overalls and work shoes.
Observe whether the personnel who enter into the clean room (area)
have been purified in accordance with the procedures, and worn
work caps, masks, clean overalls, work shoes and shoe covers
according to the provisions on the site.
Operators who contact with the products with naked hands should
disinfect their hands at regular intervals repeatedly. The type of
disinfectant for naked hands should be replaced regularly.
Check the disinfectant preparation or use records to confirm
whether the type of disinfectant for naked hands have been replaced
regularly according to requirements.
Personnel health requirements should be established and personnel health
records should be established.
Check whether the documents of the personnel health requirements
have specified the health requirements of personnel and whether
personnel health records have been created.
As to those who have direct contact with materials and drug products, a
physical examination shall be conducted at least once a year. No person
with transmissible or infectious disease shall be engaged in the
production which comes into direct contact with the products.
Check the physical examination report or health certificate of the
persons who directly contact with the materials and the products in
the clean room to confirm whether they have undergone the physical
examination within the stipulated time, and those who are suffering
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Chapter Terms Content
from infectious and transmissible diseases are not engaged in the
work that may be in direct contact with the product.
The clothing requirements of personnel should be specified and the
management requirements of clean and sterile garments should be
developed. The protective garments and their quality shall be appropriate
to the requirements of production operation and cleanliness class of
operational area. The style and way of wearing of protective garments
shall meet the requirements of the products and personnel protection. The
aseptic garments shall be able to cover completely hair, beard and feet
and prevent body materials from being left.
Check the management requirements for clean and sterile work
clothes; observe the suitability of clothing and the compliance of
personnel wearing on the site.
The garments used in clean areas shall be free from shed fibers and
Check whether the garments used in clean areas are made of
materials that are smooth, free from static electricity, and not shed
fibers and particulates.
Premises and
2.1.1 The plant and the facility shall meet the production requirements.
The design, layout and use of premises and the facilities shall be
reasonable in accordance with the characteristics of the products
produced, the technological process and the corresponding cleanliness
2.2.2 Production environment should be clean and in line with product quality
needs and related technical standards.
For products with special requirements, the external environment of
premises must not have an impact on product quality, and verification
should be conducted if necessary.
Premises must not adversely affect, directly or indirectly, either the
pharmaceutical products during their manufacture and storage, or the
accurate functioning of equipment.
2.3.2 Lighting, temperature, humidity and ventilation in premises should be
For the design and installation of premises and facilities, necessary
measures should be taken according to the characteristics of the product.
The entry of insects or other animals should be avoided effectively.
Check whether relevant facilities are provided on the site.
2.4.2 Maintenance and repair of the premises and facilities shall not affect the
quality of the product.
2.5.1 Production area should have enough space that matches production scale
and varieties.
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Chapter Terms Content
Storage areas should be able to meet storage conditions and requirements
of the raw materials, packaging materials, intermediate products, finished
products and so on.
Materials and products should be stored in the storage area according to
their status (e.g. on quarantine, released, rejected, returned or recalled) to
facilitate check and monitor.
Check whether the relevant areas are established and identified on
the site, and whether various types of materials are stored in the
required area, whether there are storage records of various items.
Should have inspection premises and facilities appropriate for production
scale, varieties and inspection requirements.
Verify whether the enterprise has the relevant testing conditions
based on the production process requirements and product testing
requirements and testing methods.
There should be a clean production environment. The plant ground, road
surroundings and transportation should not contaminate the production of
implantable sterile medical devices. The plant area should be far from the
areas with contaminated air and water.
Check whether the production environment is clean and free from
residual water and weeds on the site. The plant ground, road
surroundings and transportation should not contaminate the
production of the product. Check the leveling of the ground and road
and measures for reducing the exposed earth and dust and plant
greening, as well as storage of garbage, idle items and so on.
The general layout of the administrative area, living area and auxiliary
area shall be reasonable and shall not adversely affect the production
Should determine the production process within the clean room (area) at
corresponding cleanness level based on the quality requirements of the
production of the implantable sterile medical device to avoid
contamination in production.
Check whether relevant documents have specified the cleanliness
levels of the production process; check whether the production is
conducted within the clean room (area) at corresponding cleanness
level, and whether contamination in production can be avoided.
The static pressure difference between clean room (area) with different
air cleanness levels should be greater than 5 Pa, and between the clean
room (area) and the outdoor atmosphere greater than 10 Pa, and there
should be a device indicating the differential pressure.
Check whether there is a device indicating the differential pressure
and the static pressure difference between different clean rooms
(area) and between the clean room (area) and the outdoor
atmosphere is in compliance with the requirements on the site.
If necessary, an appropriate differential pressure gradient should be
maintained between the different functional areas (operating rooms) of
the same cleanness level.
Check different functional areas (operating rooms) of the same
cleanliness level, and whether an appropriate differential pressure