The key points of quality system construction based on "MAH Implementing the Provisions on the Supervision and Management of Drug Quality Subject Responsibility"

Key points

Qualification requirements

Primary responsibilities

Responsibilities and requirements of the person in charge of the enterprise

The person in charge of the enterprise shall have working experience in pharmaceutical-related fields and be familiar with relevant laws, regulations, rules and regulations
of drug supervision and administration.

1. The person in charge of the enterprise is fully responsible for the daily management of the enterprise and implements the main responsibility of quality management in the whole process;
2. Responsible for assigning a special quality manager, providing necessary conditions and resources, and ensuring that the quality management department performs its duties independently;
3. Responsible for the allocation of special quality authorized personnel to ensure the independent performance of drug marketing release responsibilities;
4. Responsible for handling major safety incidents related to drug quality to ensure that risks are controlled in a timely manner;
5. Responsible for establishing a training and assessment system for production management and quality management;
6. Responsible for appointing or designating a person in charge of
   pharmacovigilance.
   

Responsibilities and requirements of the person in charge of production

Pharmacy or related professional background, bachelor degree or above or intermediate or above professional and technical title or licensed pharmacist qualification, more than three years of practical experience in drug production and quality management, including at least one year of drug production management experience, familiar with relevant laws, regulations and rules and regulations
of drug production management.

1. Mainly responsible for drug production management, to ensure that drugs are organized for production and storage in accordance with approved process procedures;
2. Ensure the good operation of the plant and facilities and equipment, complete the necessary verification work, and ensure the quality of drug production;
3. Ensure the effective operation of the production management training system, and carry out training and assessment
   for all personnel of drug production management.
   

Quality manager responsibilities and requirements

Pharmacy or related professional background, bachelor degree or above or intermediate or above professional and technical title or licensed pharmacist qualification, more than five years of practical experience in drug production and quality management, including at least one year of drug quality management experience, familiar with relevant laws, regulations and rules and regulations
of drug quality management.

1. Responsible for drug quality management, establish quality control and quality assurance system, supervise the implementation of relevant quality management specifications, and ensure the effective operation of the quality management system;
2. Ensure that the production process control and drug quality control meet the requirements of relevant regulations and standards;
3. Ensure the truthfulness, accuracy, completeness and traceability of data and records of drug production, inspection and so on;
4. Ensure the effective operation of the quality management training system, and carry out training and assessment
   for all personnel of drug quality management.
   

Quality Assignee's responsibilities and requirements

Pharmacy or related professional background, bachelor degree or above or intermediate or above professional and technical title or licensed pharmacist qualification, more than five years of practical experience in drug production and quality management, engaged in drug production process control and quality inspection, familiar with relevant laws, regulations and rules and regulations
of drug supervision and administration.

1. The quality authorized person independently performs the duties of drug release to ensure that the production and inspection of each batch of released drugs comply with relevant laws and regulations, drug registration management requirements and quality standards
   .
   Without the signature and consent of the quality licensee, the product shall not be released
   .
   
2. The holder can set up multiple quality licensees according to the size of the enterprise, covering the release responsibilities
   of all products of the enterprise.
   Each quality authorized person shall have a clear division of labor and must not overlap.
   
   When the quality authorized person is absent for any reason, after approval by the legal representative of the enterprise or the person in charge of the enterprise, he may temporarily transfer his duties to other quality authorized persons or personnel with relevant qualifications, and stipulate in writing the scope, matters and time limit
   of the subauthorization.
   During the period of sub-authorization, the original quality licensee must still bear the corresponding responsibility
   .
   

Duties and requirements of the person in charge of pharmacovigilance

Managers with certain positions shall have: medical, pharmacy, epidemiology or related professional background, bachelor degree or above or intermediate or above professional and technical titles, more than three years of work experience in pharmacovigilance, familiar with China's pharmacovigilance-related laws, regulations and technical guidelines, and have the knowledge and skills
of pharmacovigilance management.

1. Responsible for the establishment, operation and continuous improvement of the pharmacovigilance system, and ensure that the pharmacovigilance system meets the requirements of
   relevant laws and regulations and pharmacovigilance quality management practices.
   

Key points

request

Production management requirements

Production is carried out in accordance with national drug standards, quality standards and production processes approved by the drug administration department to ensure that the whole process of drug production continues to meet the requirements of
good manufacturing practices.

Quality management requirements

Meet the quality objectives of drug quality management requirements, continuously improve the quality management system, and ensure that the drugs produced meet the intended use and registration requirements
.

Raw and auxiliary package management requirements

The holder shall audit suppliers of raw materials, excipients, packaging materials and containers that directly contact drugs, and ensure that the raw materials, excipients, packaging materials and containers purchased and used in direct contact with drugs meet the requirements for medicinal use, and comply with the quality management specifications formulated by the drug regulatory department under the State Council and the relevant requirements of relevant laws and regulations such as the corresponding related review and approval
.

Change management requirements

Establish a post-marketing change control system for drugs, formulate and implement internal change classification principles, change lists, working procedures and risk management requirements; The change management category shall be determined after full research, evaluation and necessary verification in combination with the characteristics of the product, and shall be implemented after approval and filing, or specified in the annual report
.

Release management requirements

Establish procedures for the release of drugs, clarify the standards and conditions for factory release, and review the quality inspection results, key production records and deviation control of drugs, and conduct quality inspection
of drugs.
If it meets the relevant standards and conditions, it can be released from the factory only after being signed by the quality authorized person
.

Commissioned production management requirements

Organize the production of commissioned drugs in accordance with good manufacturing practices, actively cooperate with the audit of the holder, and take corrective and preventive measures to implement rectification in accordance with all defects found in the audit
.

Storage and transportation management requirements

Where the storage, transportation or sale of drugs is entrusted, the holder shall assess the quality assurance ability and risk management ability of the entrusted party, sign an entrustment agreement and quality agreement with the entrusted party in accordance with relevant provisions, and periodically review the storage and transportation management of the entrusted enterprise to ensure that the storage and transportation process meets the requirements of the quality management practice for drug business and the storage conditions of drugs
.

Traceability management requirements

Establish and implement a drug traceability system, build an information traceability system by yourself or entrust a third party to build an information traceability system as required, give drug traceability labels in the sales and packaging units of drugs at all levels, provide traceability information to downstream pharmaceutical trading enterprises and drug use, timely and accurately record and save the whole process of drug information, realize drug traceability, and provide traceability data
to the drug regulatory department in accordance with regulations.

Drug recall management requirements

Establish and improve the drug recall system, and if it is found that the drug has quality problems or other potential safety hazards, initiate the recall in accordance with the relevant provisions, promptly notify the relevant enterprises or use it, and submit the investigation and assessment report, recall plan and recall notice to the local provincial drug regulatory department for the record
.
Where the recalled drugs need to be destroyed, they shall be destroyed
in accordance with relevant provisions.

After the recall is completed, the recall and handling of the drug shall be promptly reported
to the local provincial drug regulatory department and the competent health department in accordance with relevant provisions.

Pharmacovigilance requirements

Establish a pharmacovigilance system, set up a special pharmacovigilance department, carry out pharmacovigilance work in accordance with the requirements of pharmacovigilance quality management practices, and carry out activities such as monitoring, identification, evaluation and control of adverse drug reactions and other harmful reactions related to medication, so as to minimize drug safety risks
.

Post-marketing research requirements

Formulate a post-market risk management plan, actively carry out post-marketing research, and regularly carry out post-market evaluation based on post-market research on drug safety, efficacy and quality controllability, and conduct comprehensive analysis and evaluation
of drug benefits and risks.
According to the evaluation results, quality improvement or risk prevention and control measures
such as revising drug instructions, improving quality standards, improving process prescriptions, suspending production and sales, recalling drugs, and applying for cancellation of drug approval documents are taken in accordance with the law.

For drugs with conditional approval, the holder shall take corresponding risk management measures and complete relevant research
as required within the specified period.

Drug safety incident requirements

Formulate drug safety incident handling plans, and regularly organize and carry out training and emergency drills
.
In the event of a major safety incident related to drug quality, the holder shall immediately take effective measures to dispose of the relevant drug and its raw materials, excipients, packaging materials and containers directly in contact with drugs, relevant production lines, etc.
, to prevent the harm from expanding
.

Discontinuance reporting management requirements

Establish a reporting system for the suspension of production of
drugs in short supply.
Where the production of drugs included in the list of shortage drugs included in the national implementation suspension report is stopped, it shall be reported to the local provincial drug administration department six months before the planned suspension of production; In the event of an unexpected suspension of production, it shall be reported to the local provincial drug administration department
within three days.
If necessary, report
to the State Drug Administration.

Liability Claims

Establish relevant management procedures and systems for liability compensation, and implement the system
of primary responsibility for compensation.
The liability compensation capacity should match
factors such as the risk degree of the product, the market size and the personal injury compensation standard.
The holder shall have relevant certificates of liability compensation capacity or corresponding commercial insurance purchase contracts
.

Batch review mechanism

Supervise the implementation of drug manufacturing quality management practices and other requirements in the production and inspection process of each batch of drugs, organize the investigation of deviations that occur, and take timely control measures for potential quality risks; The person in charge of quality shall ensure that the review of production records and inspection records is completed before the release of each batch of drugs, that quality-related changes are reviewed and approved in accordance with regulations, and that all major deviations and inspection over-standards have been investigated and dealt with in a timely manner
.

Quarterly analysis mechanism

Combined with product risks, regularly organize a review and analysis of production management, quality management, etc.
, in principle, no less than once a quarter to study and judge repetitive risks and emerging risks, formulate corrective and preventive measures, and continuously improve the quality management system
.
The person in charge of the enterprise shall regularly listen to the quality management work report of the quality responsible person, fully listen to the opinions and suggestions of the quality person in charge on the prevention and control of drug quality risks, and provide necessary conditions and resources for the implementation of quality risk prevention and control
.

Annual report management requirements

Establish an annual reporting system
.
The person in charge of the enterprise shall designate specialized agencies or personnel to be responsible for the annual report work, to ensure that the information in the annual drug report is true, accurate, complete and traceable, and complies with the requirements
of laws, regulations and relevant provisions.
The report writer shall summarize the production and sales, post-marketing research, risk management, etc.
of the drug in the previous natural year, form an annual report in accordance with the annual report template formulated by the State Medical Products Administration, and report
to the local provincial drug administration department after approval by the legal representative of the enterprise or the person in charge of the enterprise (or his written authorization).

Self-test management requirements

Regularly conduct self-inspection or internal audits to monitor the implementation of
good manufacturing practices, good management practices for drug sales, and quality management practices for pharmacovigilance.
Self-inspection or internal audit shall have a plan and records, and a self-inspection report shall be formed after the completion of the self-inspection, including at least the basic situation of the self-inspection, the conclusions of the evaluation, and suggestions for
corrective and preventive measures.

Training management requirements

Establish a training management system, formulate training programs or plans, and carry out pre-job training and continuing training
for all personnel engaged in drug research and development management, production management, quality management, sales management, pharmacovigilance, and post-marketing research.
The training content includes at least relevant regulations, corresponding job responsibilities and skills, etc
.
The holder shall keep training records and periodically evaluate the effectiveness of
training.