What are the GMP specifications of pharmaceutical factories Help me with the content of those Thank

The purpose of implementing GMP is as follows:

GMP is a system to ensure the continuous production of pharmaceutical products under the specified quality. It is designed to minimize the risk of non-conformity in the production of pharmaceutical products. GMP encompasses all aspects of requirements, from the plant to the ground, equipment, personnel and training, hygiene, air and water purification, production and documentation.

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.

The implications of implementing GMP are as follows:

1. It is conducive to the development of new drugs and generic drugs for enterprises. According to the regulations, from May 1, 1999, the State Drug Administration will accept the application.

For the third, fourth and fifth categories of new drugs, the manufacturer must obtain the "drug GMP certificate" of the corresponding dosage form or workshop before handling the production approval number in accordance with the relevant regulations.

2. It is conducive to the renewal of the "Drug Manufacturing Enterprise License". Newly established drug manufacturers must pass GMP certification and obtain the "Drug GMP Certificate" before they can issue the "Drug Manufacturing Enterprise License". Within the specified period, enterprises that have not obtained the "Drug GMP Certificate" will not be reissued with the "Drug Manufacturing Enterprise License".

This means that the survival of the enterprise is seriously threatened.

3. It is conducive to improving the reputation of enterprises and products and improving competitiveness. Because all enterprises or workshops that have passed GMP certification have been issued with "GMP certificates", and announcements have been published in relevant newspapers, and the relevant content of GMP certification can also be applied to the promotion of enterprises and stove products. This will inevitably further improve the image and reputation of the enterprise (workshop), improve the competitiveness of the market, and occupy a larger market.

4. It is conducive to improving the scientific management level, promoting the improvement of the quality of enterprise personnel and enhancing quality awareness, and ensuring the quality of drugs. GMP management is a scientific and advanced management method, and its biggest feature is that it not only attaches importance to the result, but also attaches importance to the process. The main content of GMP is to eliminate the hidden dangers of contamination, confusion and errors in the production of drugs, which cannot be completely controlled by the inspection of the finished product results alone.

In order to adapt to the new situation and new development of China's pharmaceutical industry, and improve the quality of drugs within stricter and more perfect drug manufacturing quality management practices, the Ministry of Health implemented 2010 on March 1, 2011

years of revised GMP. According to the requirements of the new version of GMP, GMP certification has changed from static to dynamic in the past, which means that the requirements for clean rooms are getting higher and higher, and pharmaceutical companies must carry out all-round quality control from the aspects of design, construction and post-operation management to meet the new version of GMP

Request. As an important stage of the formation of the clean room, the construction personnel are required to make and install in strict accordance with the requirements of the clean room. Clean air conditioning system, purification color steel plate system and clean floor are important parts of the clean room to ensure high quality and high level of construction.

GMP certification has been successfully passed.

Specifically, you can go to the official website of Changsha Lianyan Electromechanical to view, there are the latest requirements and standards!

GMP is the national standard for the quality of drug production, which mainly includes the advanced production equipment, the strict operation of the production process, the high standard of air quality in the workshop, and the advanced software management. The requirements for the quality of personnel are the management standards of gmp in pharmaceutical factories.

Answer]: It is a comprehensive management norm including personnel, plant, equipment, hygiene, raw materials, production operation, packaging and labeling, production management and quality management, quality management department, self-inspection, sales records, and adverse reactions.

Summary. What are the basic requirements of GMP for pharmaceutical equipment?

GMP certification of Chinese medicine decoction pieces.

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 the drug, including organized, planned whole-spike cortex activities to ensure that the quality of the drug is fit for its intended use.

Article 3 As a part of the quality management system, this specification is the basic requirement of the Chinese community 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's requirements for pharmaceutical equipment are as follows:

In addition to the requirements of the production process, the requirements of gmp for the equipment should be able to prevent cross-contamination without affecting the product quality, be easy to clean and maintain, and the layout design can minimize the risk of errors.

The design and installation of equipment in pharmaceutical enterprises should meet the requirements of drug production and technology, and the inner surface of the equipment and the surface of the working parts in direct contact with the drug should not be designed with exposed bolt connections such as platforms and grooves as much as possible, and the surface should be smooth, smooth, and without dead ends, so as to ensure that the product quality can be effectively controlled.

1. Purification function. Cleanliness is one of the key points of GMP, which has two meanings for the equipment, namely: the equipment itself does not pollute the production environment and the ears do not pollute the drug.

2. Cleaning function. The cleaning-in-place (CIP) function advocated by gmp will be the development of cleaning technology.

4. Safety protection function. Drugs have different properties such as heat sensitivity, moisture absorption, volatilization, reaction, etc., and it is easy to cause changes in drug quality if you do not pay attention to these characteristics, which is also a problem that should be paid attention to in equipment design.