Decree 218 Annex 1 Good Manufacturing Practice Guidelines For Onsite Inspection

Annex 1
Good Manufacturing Practice for Medical
Device
Field Inspection Guideline
Chapter Terms Content
Institu
tion
and
Perso
nnel
1.1.1
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.
*1.1.2
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 quality.
1.1.3
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.
1.2.2
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.
1.2.3
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 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.
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Chapter Terms Content
*1.2.5 The person in charge of the enterprise shall organize the production in
accordance with the requirements of laws, regulations and rules.
1.3.1
The person in charge of the enterprise shall determine a management
representative.
Check the appointment file for the management representative.
*1.3.2
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.
1.4.1
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.
1.5.1
Should have technical personnel, managers and operators appropriate for
production of products.
Check the eligibility requirements of the relevant personnel.
*1.5.2
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.
*1.6.1
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.
1.7.1 The health of personnel engaged the work affecting the product quality should be
managed and health records should be created.
Premi
ses
and
Faciliti
es
2.1.1 The plant and the facility shall meet the production requirements.
2.1.2
The overall layout of the production, administration and auxiliary area should be
reasonable, and should not interfere with each other.
*2.2.1 The design, layout and use of premises and the facilities shall be reasonable in
accordance with the characteristics of the products produced, the technological