What are the relevant supporting documents for the quality type of the drug?

In order to ensure the quality of microbial testing and inspection of drugs, all detection methods must be verified, and only after the verification and confirmation of the detection method can the accuracy and reliability of the verification results be ensured.

Original research, patent GMP and so on. Generally, it is stated in the bidding documents, and you can refer to the bidding documents of each province specifically.

1.Product patent certificates: domestic and foreign compound patents, composition patents (original research certificates), National Science Progress Award, etc.

2.The manufacturer has no fake and inferior drug certificate (certified by the Food and Drug Administration of prefecture-level cities and provincial bureaus) 3The production line, inventory conditions, and shelf life of the product are due to other competitive product certificates.

The above is for reference.

The collection of drug quality information is to collect information reports on drug quality from medical newspapers and periodicals, and can also collect drug quality reports from the State Food and Drug Administration or provincial and municipal drug administrations. Evaluation or notification of a drug can be done.

It is divided into drug quality information, drug enterprise supervision information, drug substandard product information, drug quality accidents, drug laws and regulations information, and drug policy transfer information.

Drug quality acceptance records.

This includes inspection records of quantity, appearance quality, and packaging quality.

1. Quantity acceptance.

Check the consistency of the physical object with the warehousing voucher (or the return voucher after cancellation).

2. Appearance quality acceptance.

According to the drug instructions and drug standards, the necessary items and contents of the appearance quality requirements of different dosage forms are checked. The appearance quality of large and small infusions and water injections needs to be checked with a clarity detector.

3. Packaging acceptance.

Inspect the inner packaging, middle packaging, and outer packaging separately. The items to be inspected are: the quality of the packaging, the content that must be printed (in accordance with the relevant regulations) and the entire package must be accompanied by a product certificate of conformity.

Imported drugs should also have a copy of the "Imported Drug Registration Certificate" and "Imported Drug Inspection Report" stamped with the original seal of the supplier's quality management organization.

The acceptance record of the accepted drug shall be made, including the generic name, dosage form, specification, approval number, batch number, production date, expiration date, manufacturer, supplier, arrival quantity, arrival date, acceptance quantity, acceptance results, etc. The acceptance personnel shall sign the name and acceptance date on the acceptance record.

The acceptance record of Chinese herbal medicines shall include the product name, place of origin, supply unit, quantity of arrival, quantity of acceptance, etc. The acceptance record of traditional Chinese medicine decoction pieces shall include the product name, specification, batch number, place of origin, production date, manufacturer, supply unit, arrival quantity, acceptance quantity, etc., and the approval number shall also be recorded for the Chinese medicine decoction pieces subject to approval number management.

If the acceptance is unqualified, the unqualified items and disposal measures shall also be indicated.

1. According to the provisions of the quality system procedures, the quality acceptance of the warehousing drugs (including the drugs returned after sale) is carried out, and the relevant quality requirements are responsible for the warehousing.

2. Batch by batch acceptance of the incoming drugs (including drugs returned after sale), including packaging, labels, instructions and relevant required certificates or documents (such as imported drug registration certificates, drug inspection reports, certificates) and appearance quality; Injections and eye drops should be tested for clarity as needed;

3. The drugs that have passed the experience must be signed on the original voucher, and the drugs that have not been accepted and signed shall not be stored as normal drugs, stored in the waiting area or hung with yellow marks.

4. Drugs that are unqualified or have quality problems should be entered into the nonconforming product area and reported to the person in charge of quality management for proper handling.

5. In the acceptance, the drugs with doubts about the quality should be marked with a yellow card and properly dealt with immediately to the person in charge of quality management.

6. The quality records of the accepted drugs should be made batch by batch according to the requirements of quality records, including quality inquiry, return processing, unqualified drugs and other records, and properly kept.

7. If damage and shortage are found in the acceptance, you should take the initiative to contact the shipper to reduce the loss.

Drug management institutions.

Drug regulatory organization and management system.

Drug regulatory functions and tasks.

Administrative law enforcement of drug administration.

Legal responsibility for drug administration.

National Drug Management Policy.

Rules and regulations for drug inspection.

Management of drug inspectors.

Responsibilities and systems of drug testing personnel.

Procedures for the management of drug testing institutes.

Specification of drug testing.

Drug testing business management system.

Department management and assessment.

Comprehensive management system for drug quality inspection and testing.

Pharmaceutical standards. Pharmaceutical test reference materials.

Management of drug inspection strains.

Drug inspection information management.

Management of drug testing instruments and equipment.

Adverse drug reaction monitoring system.

Pharmaceutical inspection technology management.

Chemical reagents for drug testing.

Drug quality inspection and identification technology and operation specifications.

General testing for the identification of counterfeit and inferior drugs.

General identification tests for pharmaceutical products.

Determination of the physical constants of drugs.

Chemical determination of drug content.

Pharmaceutical bioassays.

Drug impurity checking.

Methods for the analysis and testing of pharmaceutical instruments.

Formulation quality checks.

Quality standard analytical method validation and stability testing.

Drug production quality inspection management and drug GMP supervision system.

Pharmaceutical production quality management.

The basic principles of quality management in pharmaceutical manufacturing.

Specification of pharmaceutical production plants and facilities.

Pharmaceutical production management operation specifications.

Quality control. Hygiene management.

Production self-inspection. Drug GMP certification management system.

Pharmaceutical business quality management system and administrative supervision.

Quality management of pharmaceutical business.

Quality supervision of pharmaceutical commodity operation.

Examination and approval management for the establishment of pharmaceutical business enterprises.

Drug procurement management system.

Drug** Management Policy.

The quality inspection and supervision system and management of drugs and pharmaceuticals in medical institutions standardize the pharmaceutical management of medical institutions.

Standardization system and management norms in the pharmaceutical industry.

Pharmaceutical procurement and storage system for medical institutions.

Drug quality inspection system for medical institutions.

Prescription and dispensing management system for medical units.

Pharmaceutical quality standards and quality management systems for medical institutions.

Drug expiration date management system and methods of medical institutions.

Rational drug use system.

Drug administrative management system and national legal supervision.

Drug development management system and legal supervision.

Medical device management system and legal supervision.

Drug production management system and legal supervision.

Drug management and its liability for violations.

Pharmaceutical business management system and legal supervision.

Traditional Chinese medicine management system and legal supervision.

Special drug management system and legal supervision.

Drug use management system and legal supervision.

Inspection and testing specifications and national standards for drugs and medicinal materials.

Drug Supervision and Drug Regulatory Specifications.

In order to ensure the quality of drugs, the regulations on various inspection items, indicators, limits, scopes, etc., are called drug quality standards. The drug quality standard is the comprehensive performance of the purity, ingredient content, composition, bioavailability, efficacy, toxicity, pyrogenicity, sterility, physical and chemical properties and impurities of the drug.

There are two types of drug quality standards: statutory standards and enterprise standards. Statutory standards are further divided into national pharmacopoeia, industry standards and local standards. The production of drugs shall be subject to the pharmacopoeia, the industry standard shall prevail for the drugs not included in the pharmacopoeia, and the local standard shall prevail if it is not included in the industry standard.

Drugs that do not meet the statutory standards and do not meet the statutory standards are not allowed to be produced, sold and used. National drug standards refer to the Pharmacopoeia of the People's Republic of China, drug registration standards and other drug standards promulgated by the State Food and Drug Administration, including technical requirements such as quality indicators, inspection methods and production processes. Others are based on this, and the local standards are mainly based on authentic medicinal materials and secret recipes, such as Mongolian medicine, Tibetan medicine and other ethnic medicines.

The concept of drug quality can be understood as the physical, chemical, biopharmaceutical, safety, efficacy, stability, and uniformity of drugs.

The degree to which indicators such as oneness meet the prescribed standards.

China's National Drug Standards.

The current edition of the Pharmacopoeia of the People's Republic of China is the 2000 edition, which is divided into one and two parts. One contains commonly used Chinese herbal medicines and.

traditional medicines such as Chinese patent medicines; The second part contains commonly used chemicals, biological products, antibiotics, radiopharmaceuticals and other modern medicines.

The Bureau issues drug standards, including the Chinese Biological Products Regulations, Drug Hygiene Standards and all those that are not included in the Pharmacopoeia.

Pharmaceutical standards.

The Pharmacopoeia of the People's Republic of China is referred to as the Chinese Pharmacopoeia and the Standards of the Food and Drug Administration of the People's Republic of China are referred to as the Standards issued by the Bureau (Ministry) or the Standards of the Bureau (Ministry).

In order to ensure the quality of drugs, the state has mandatory quality standards for drugs, that is, drug quality standards. Drug quality standards are divided into national drug standards and other drug standards. The national drug standards are divided into the Chinese Pharmacopoeia and the Drug Standards issued by the Bureau, and the other drug standards are divided into the Quality Standards for Clinical Research Drugs, the Interim or Trial Drug Standards and the Enterprise Standards.

Laws related to drug quality include the Drug Administration Law of the People's Republic of China

Article 48: The production (including preparation, the same below) and sale of counterfeit drugs are prohibited.

In any of the following circumstances, it is a counterfeit drug:

1) The ingredients contained in the drug are inconsistent with the ingredients specified in the national drug standards;

2) Passing off non-drugs as drugs or passing off other drugs as such drugs.

Drugs with any of the following circumstances shall be treated as counterfeit drugs:

1) The drug regulatory department prohibits its use;

2) Producing or importing without approval that must be approved in accordance with this Law, or selling without inspection that must be inspected in accordance with this Law;

c) spoiled;

4) contaminated;

5) Produced using APIs that must obtain an approval number in accordance with this Law but have not obtained an approval number;

6) The indicated indications or functional indications are beyond the scope provided.

Article 49 The production and sale of inferior drugs are prohibited. If the content of the drug ingredient does not meet the national drug standards, it is an inferior drug.

Drugs with any of the following circumstances shall be treated as inferior drugs:

1) Failure to indicate the validity period or change the validity period;

2) Failure to indicate or change the production batch number;

3) The validity period has expired;

4) The packaging materials and containers that are in direct contact with the drug are not approved;

5) Unauthorized addition of colorants, preservatives, spices, flavoring agents and auxiliary materials;

6) Other non-compliance with the provisions of drug standards.

Article 65: According to the needs of supervision and inspection, the drug regulatory department may conduct random inspections on the quality of drugs. Random inspections shall be sampled in accordance with regulations, and no fees shall be charged. The required expenses shall be paid in accordance with the provisions of ***.

The drug regulatory department may take administrative compulsory measures such as sealing and seizure of drugs and related materials that may endanger human health if there is evidence to prove that they may endanger human health, and make an administrative decision within seven days; If the drug needs to be tested, an administrative decision must be made within 15 days from the date of issuance of the test report.

If the law does not allow medicines, many people who get sick will die.