GMP

Legal basis

According to the Announcement on Releasing the Good Manufacturing Practice for Medical Devices and the Notice on Matters Concerning the Implementation of the Good Manufacturing Practice for Medical Devices of the NMPA (CFDA), from January 1, 2018, all medical device manufacturers must meet the requirements of the Good Manufacturing Practice (GMP), and the drug administration departments at all levels will conduct the on-site inspection of the enterprises in accordance with the requirements of the Good Manufacturing Practice. The manufacturers that fail to meet the requirements of the Good Manufacturing Practice within the specified period of time will be dealt with in accordance with the relevant provisions of the Regulations for the Supervision and Management of Medical Devices.

Inspection standards

There are 13 chapters and 84 articles in the Good Manufacturing Practice, making specifications on organization and personnel, plants and facilities, equipment, document management, design and development, purchasing, production management, quality management, sales and after-sales service, control of nonconforming products, detection, analysis and improvement of adverse events, and other aspects.

According to the Good Manufacturing Practice and its related appendixes, the NMPA has formulated the Good Manufacturing Practice - On-site Inspection Guidelines, Good Manufacturing Practice - On-site Inspection Guidelines for Sterile Medical Devices, Good Manufacturing Practice - On-site Inspection Guidelines for Implantable Medical Devices, Good Manufacturing Practice - On-site Inspection Guidelines for In Vitro Diagnostic Reagents, Good Manufacturing Practice - On-site Inspection Guidelines for Independent Software, etc., and instructions for the inspection and explanations of the key inspection points in each article are provided.

Scope of application

It is applicable to the on-site inspection of medical device manufacturers for the first registration, on-site inspection for medical device production licenses (including renewal or change), and various supervision and inspection of medical device manufacturers carried out by regulatory authorities at all levels according to work needs.

Inspection items

1. On-site inspection for medical device registration and production license (including change):

a) If no nonconforming items are found in the enterprise during the on-site inspection, the conclusion is “Pass”.

b) During the on-site inspection, if it is found that the key items of the enterprise (marked with “*”) do not meet the requirements, or although only the general items (not marked with “*”) do not meet the requirements, they may have a direct impact on product quality, the conclusion is “Fail”.

c) If there are only general items that do not meet the requirements and they do not have a direct impact on product quality, the conclusion is “Re-inspect after rectification”.

2. Production license renewal:

If the enterprise is found to have nonconforming items, the enterprise shall be notified to make rectification within a specified period of time, and if the requirements cannot be met after the rectification, the production license shall not be renewed.

3. Various supervision and inspection

   If it is found that the key items do not meet the requirements, or although only the general items do not meet the requirements, they may have a direct impact on product quality, the enterprise shall be required to stop production for rectification; if only the general items do not meet the requirements and they do not have a direct impact on product quality, the enterprise shall be required to rectify them within a specified period of time.

Service contents

SUNGO can provide professional and personalized GMP related services for customers with different needs:

      --For the manufacturers which have just entered the medical device industry, we can provide comprehensive        and systematic services, including:

·  Counsel the enterprise on making and implementing the plans and schemes for plant construction, facility and equipment selection review, corporate organizational structure, and staffing

·  Establish, operate and maintain the quality management system

·  Prepare the quality management system documents

·  Track the current status of the enterprises’ software and hardware, conduct a comprehensive and full internal review of the enterprises’ personnel, production, purchasing, research & development, quality, sales, and document management, put forward rectification opinions and schemes, and provide counseling for the implementation of the same

·  Provide technical counseling during on-site inspection by the regulatory authority, and provide counseling on the correction and prevention of nonconforming items, and the preparation of relevant rectification report documents

·  Counsel on the verification and validation of each process activity in the product life cycle

·  Carry out special training on GMP related regulations and standards, staff skills, environment, and health

--For the manufacturers which have established and operated quality management systems and have obtained domestic certificates, we can provide the following services:

·  Assist the enterprise in the collection and promotion of and training on new regulations and standards

·  Counsel the enterprise on the review and update of the quality management system documents

·  Conduct a comprehensive review of each process activity during the operation of the quality management system and propose and implement the rectification schemes

·  Evaluate the plant layout, personnel qualifications, equipment and facilities, warehouse management, environmental sanitation, and other on-site conditions related to the GMP, propose the rectification schemes, and counsel on the implementation

·  Counsel the enterprise on the reverification and revalidation required in each production/service process

·  Regularly update the risk management and adverse event monitoring information

·  Assist the enterprise in completing new product registration, renewal of registration, change of registration, and various supervision and inspection items related to on-site GMP inspection

SUNGO service process

Process	Specific task	Division of work	Cycle
1	Confirming the project tasks and paying the relevant fees	Enterprise	/
1	The project leader of the enterprise and SUNGO jointly set up a GMP special team	Both parties	1 working day
2	Collecting the enterprise information and product materials, communicating on the current status, reviewing the materials, and developing the counseling schemes and plans	Both parties	3 working days
3	System document preparation and provision	SUNGO	7-10 working days
4	On-site evaluation and counseling: Establishing a quality management system	SUNGO	3-4 working days
5	System trial operation and maintenance	Both parties	/
6	Performing full and comprehensive internal review, proposing rectification plans and protocols, and assisting in the implementation	Both parties	2-3 working days
7	On-site inspection preparation, technical counseling, and special training	SUNGO	3-5 working days
8	Accepting the on-site inspection by regulatory authorities	Both parties	/
9	On-site inspection of nonconforming items rectification, correction and prevention, and rectification report compilation	Both parties	3-5 working days
10	The GMP inspection is passed	/	/