What does GMP certification mean What is GMP certification

The GMP was developed to minimize contamination and cross-contamination in the production of pharmaceutical productsReducing the occurrence of various errors is an important measure to improve the quality of drugs.

GMP 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 of enterprises, find problems in the production process in time, and improve them.

In short, GMP requires pharmaceutical, food and other manufacturers to have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that the quality of final products (including food safety and hygiene) meets the requirements of regulations.

New version of certification. According to Order No. 79 of 2011 signed by the Minister of Health of the People's Republic of China, the Good Manufacturing Practice (2010 Revision) (hereinafter referred to as the new GMP) has been deliberated and approved by the Ministry of Health on October 19, 2010, and will come into force on March 1, 2011.

Compared with the 98th edition, China's new GMP has made considerable progress in terms of management and technical requirements. In particular, high requirements are put forward for the production of sterile preparations and APIs, and the new version of GMP is based on EU GMP, taking into account the domestic gap, and taking the WHO 2003 version as the bottom line.

There are two time nodes for the new GMP certification: the production of sterile drugs such as blood products, vaccines, and injections by drug manufacturers should meet the requirements of the new version of drug GMP before December 31, 2013; The production of other types of drugs should meet the requirements of the new version of the GMP before December 31, 2015. Enterprises (workshops) that do not meet the requirements of the new version of drug GMP shall not continue to produce drugs after the above-mentioned specified period.

The above content refers to: Encyclopedia-GMP certification.

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 issued "GMP certificates", and they have also published announcements in relevant newspapers, and the relevant content of GMP certification can also be applied in the promotion of enterprises and 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.

Summary. Hello dear dear, GMP certification refers to the "Good Manufacturing Practice" certification. It is an effective method and means to ensure the quality of drugs, and it is also an internationally accepted standard for quality management of drug production.

Hello dear and cautious, GMP certification refers to the "Good Manufacturing Practice" certification. It is an effective method and means to ensure the quality of drugs, and it is also an internationally accepted quality management standard for drug production.

Hello dear dear, GMP is specifically for the drug supervision and management of the certification document, the international Ministry of Health stipulates that since 1992, the export of drugs must be produced in accordance with GMP regulations, and the export of drugs must have GMP certification documents. GMP has been unanimously recognized by pharmaceutical companies and medical experts in most countries around the world as an excellent and essential system for quality management of pharmaceutical companies and hospital preparation rooms.

"GMP" is the abbreviation of good manufacturing practice, which means "good manufacturing practice" or "good manufacturing standard" in Chinese, and is an autonomous management system that pays special attention to product quality and health and 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 operational operating specifications to help enterprises improve the sanitary environment of enterprises, find problems in the production process in a timely manner, and improve them.