What are the specific basic principles of GMP?

GMP (good Manufacture Practice of Medical Products) is formulated to avoid contamination and cross-contamination in the drug production process to the greatest extent, reduce the occurrence of various errors, and is an important measure to improve the quality of drugs.

According to Good Manufacturing Practice

Article 1 In order to standardize the quality management of drug production, this specification is formulated in accordance with the Drug Administration Law of the People's Republic of China and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China.

Article 2 Enterprises shall establish a drug quality management system. The system should cover all factors that affect the quality of medicines, including all organized and planned activities to ensure that the quality of medicines is fit for their intended use.

Article 3 As a part of the quality management system, this specification is the basic requirement for drug production management and quality control, aiming to minimize the risks of contamination, cross-contamination, confusion and errors in the drug production process, and ensure the continuous and stable production of drugs that meet the intended use and registration requirements.

GMP is the abbreviation of English GoodManufacturing Practice, which means "Good Manufacturing Practice for Pharmaceuticals" in Chinese, and is an autonomous management system that pays special attention to product quality and health safety in the manufacturing process. It is a set of mandatory standards applicable to pharmaceutical, food and other industries, requiring enterprises to meet the requirements of health and quality in accordance with relevant national laws and regulations in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control, etc., and form a set of operable operating specifications to help enterprises improve the sanitary environment, find and improve the problems in the production process in a timely manner. Drug GMP certification is a system for the state to supervise and inspect drug manufacturers (workshops) and drug varieties in accordance with the law and obtain recognition, which is an important part of international drug supervision and management, and is also a scientific and advanced management means to ensure the stability, safety and effectiveness of drug quality.

As part of the quality management system, GMP is an essential requirement for drug production management and quality control, aiming to minimize the risk of contamination, cross-contamination, mix-ups, errors and other risks in the drug production process, and ensure the continuous and stable production of drugs that meet the intended use and registration requirements.

To say ordinary, it is to ensure the quality of drugs, and quality involves many things.

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The purpose of implementing the GMP standard:

Prevent mixing between different drugs or their ingredients;

Prevent cross-contamination by other drugs or other substances; Prevent errors and distortions in metering and information transmission;

Prevent accidents where any production and inspection steps are missed;

Prevent the occurrence of illegal accidents such as arbitrary operation and non-implementation of standards and low-limit feeding;

The main purpose of formulating and implementing GMP is to protect the interests of consumers and ensure that people use drugs safely and effectively; At the same time, it is also to protect drug manufacturers, so that enterprises have laws to follow and rules to follow; In addition, the implementation of GMP is the responsibility of the pharmaceutical industry and the law, and it is also the need for China to implement a drug quality assurance system after joining the WTO - because if the drug manufacturer does not pass the GMP certification, it may be excluded from the international technical barriers.

The GMP is based on the lessons learned from the practice of drug production, and the policy is based on public demand for strict supervision of drugs.

Good Manufacturing Practice (good Manufacture Practice of Medical Products (GMP) is the basic principle of drug production and quality management, which is applicable to the whole process of pharmaceutical preparation production and the key processes that affect the quality of finished products in the production of APIs.

Vigorously promoting drug GMP is an important measure to improve the quality of drugs in order to avoid pollution and cross-contamination in the drug production process to the greatest extent and reduce the occurrence of various errors.

GMPC Five Elements: Quality System, Procurement, Production, Subcontract Production, and Quality Management. The principle is to standardize the production of drugs, improve the quality of drugs, and ensure the safety of drugs.

After the implementation of GMPC standard management, its management level has been greatly improved; At the same time, it also plays a good role in promoting the products to enter the European and American markets, especially some cosmetics processing factories with OEM and ODM as their main business, and obtaining GMPC certification has played a good role in helping the company's business development.

GMPC Key Features:

GMPC proposes a revolutionary hybrid chain architecture, independently develops GMPC BFT innovative consensus mechanism, integrates the pan-POS staking ecology, and realizes the "multi-chain-relay chain-cross-chain" fusion chain protocol interaction and hybrid storage.

1. Revolutionary hybrid chain architecture.

2. Support interconnection between cross-chains and alliance chains.

3. The "engine engine" of global blockchain value flow.

GMPC Five Elements:

Quality system, procurement, production, subcontracting production and quality management.

Standardize the production of drugs, improve the quality of drugs, and ensure the safety of drugs.

The purpose of implementing the GMP standard:

Prevent mixing between different drugs or their ingredients;

Prevent cross-contamination by other drugs or other substances; Prevent errors and distortions in metering and information transmission;

Prevent accidents where any production and inspection steps are missed;

Prevent the occurrence of illegal accidents such as arbitrary operation and non-implementation of standards and low-limit feeding;

The main purpose of formulating and implementing GMP is to protect the interests of consumers and ensure that people use drugs safely and effectively; At the same time, it is also to protect drug manufacturers, so that enterprises have laws to follow and rules to follow; In addition, the implementation of GMP is the responsibility of the pharmaceutical industry and the law, and it is also the need for China to implement a drug quality assurance system after joining the WTO - because if the drug manufacturer does not pass the GMP certification, it may be excluded from the international technical barriers.

It includes institutions and personnel, plant and facilities, equipment and instruments, hygiene and cleanliness management, document and record management, material and product control, production management, quality management, shipment and recall management, etc. It involves all aspects of drug production and quality, emphasizing the quality management of the whole production process to ensure the production of high-quality drugs.

The basic content of GMP mainly includes three aspects: personnel (the guarantee of the implementation of GMP), plant equipment and raw materials (hardware - the basic conditions for the implementation of GMP), management system and requirements (software - the basis for the implementation of GMP).

GMP (Good Manufacturing Practice) is the basic principle of drug production and quality management. In the whole process of drug production, a set of scientific management methods are used to ensure the production of high-quality drugs with scientific, reasonable and standardized conditions and methods.

The basic principles of GMP are as follows:

1) Pharmaceutical manufacturers must have sufficient qualified technical personnel suitable for the production of drugs to undertake drug production and quality management, and clearly understand their responsibilities;

2) The operator should be trained in order to operate correctly in accordance with the regulations;

3) It should be ensured that the products are produced and controlled according to the approved quality standards;

4) Written production instructions should be issued according to each batch of production tasks, and batch production instructions cannot be replaced by production planning arrangements;

5) All production and processing should be carried out in accordance with the approved process regulations, systematically inspected according to experience, and proven to be able to produce drugs in accordance with quality requirements and their specifications;

6) Ensure that the production plant, environment, production equipment, and sanitation meet the requirements;

7) Materials, packaging containers and labels that meet the specified requirements;

8) Suitable storage and transportation equipment;

9) Strict and effective control and management of the whole production process;

10) The key steps of production and processing and the important changes produced by processing should be verified;

11) Qualified quality inspection personnel, equipment and laboratories;

12) Production records are made using manual or recorders in production to prove that all production steps completed are required by the procedures and instructions that are determined, and that the products meet the expected quantity and quality, and any deviations that occur should be recorded and investigated;

13) the risk of affecting the quality of the products in the storage and sale should be minimized;

14) Establish an effective system for recovering any batch of products from sales and channels;

15) Understand the opinions of users of commercially available products, investigate the causes of quality problems, and propose treatment measures and preventive measures to prevent recurrence.

16) Verify a new production process, production process, equipment and materials, and prove whether the expected results can be achieved through systematic verification.

Pharmaceutical company gmp, I have a gmp file, send it to your email?

Pollution should be prevented everywhere in production.

The original meaning of "pollution" is "refers to the adulteration or contamination of raw materials or finished products by microorganisms or other foreign substances". The original meaning of "confusion" refers to "one or more other raw materials or finished products to be mixed with the raw materials or finished products marked with the product name, etc.", commonly known as "mixed drugs". In the essence of the problem, "confusion" can also be seen as a kind of "pollution".

"Pollution" can also be understood in a broader sense: the quality problems of products caused by pollution, mixing, discrepancies, distortion, omissions, arbitrariness, etc., can be regarded as "contaminated". A careful study of the "Veterinary Drug GMP" can understand that the entire "Veterinary Drug GMP" is discussing how to prevent product contamination.

GMP's management of veterinary drugs is to prevent "pollution" from the aspects of production environment, plant, personnel (cleanliness and behavior), facilities (equipment and containers), raw and auxiliary materials, production technology, packaging, warehousing, sales, transportation and management system.

While preventing product pollution, it is also necessary to prevent the production of veterinary drugs from polluting the environment and preventing damage to production personnel. That is, the production of veterinary drugs should take into account its safety for the environment and people.

Everything needs to be verified.

The implementation of GMP is the implementation of production activities in the course of extensive validation and repeated validation (pre-validation, simultaneous validation, in-process validation, and project-based validation).

The various tests, inspections, tests, assessments, data collection and analysis, etc., discussed in the GMP, are essentially a means of verification.

GMP stipulates that the scope of verification includes: environmental (plant) verification, facility (equipment) verification, raw material quality verification, process verification, inspection method verification, operation verification, metrological verification, product inspection, etc.

GMP asks why everything (activities) in the production process (raw materials, equipment, etc.). What do you think? Good no good? Okay? ——Verified - Rest assured.

All work is in accordance with the system (SOPs can also be understood as a form of system).

The core of GMP management is to rely on the formulation of the system and the strict implementation of the system. To summarize the following points:

There must be a system for a job (or activity).

If there is a system, it must be implemented.

If there is implementation, it must be recorded.

If there is a record, it should be synthesized (analyzed, checked).

If there is synthesis (analysis, inspection), it is necessary to improve (improve, revise).

All systems must be resolutely implemented, consciously observed, and persevered.