How to do GMP certified quality management system

My colleague just did it.,,It doesn't seem to be easy.。。

Like the ISO9000 series of standards, GSP is also a quality management system based on process management, and the quality management of the enterprise should be realized through the management activities of various processes in the industry. GSP stipulates that there are two kinds of processes that need to be managed: one is the drug business process that directly affects the quality of drugs

Including the first enterprise audit, drug purchase (first variety review), acceptance, storage, maintenance, outbound review, sales, transportation, returns, substandard drug control management, special drug control management, etc.; The second is to ensure that the work of each stage of the drug quality cycle can be done better and some necessary support processes: organization, personnel, information, facilities and equipment, rules and regulations, quality management activity records and internal audit of the quality management system.

GMP is the abbreviation of good manufacturing practice, which translates to "good manufacturing practice" in Chinese, and refers to the quality management system of pharmaceutical, medical device, food and other industries. The main purpose of the GMP quality management system is to ensure the quality and safety of products, while at the same time guaranteeing the compliance and reliability of the production process. The GMP quality management system includes the following aspects:

1.Equipment management: including equipment purchase, installation, maintenance, calibration, etc., to ensure the normal operation of equipment and the stability of production.

2.Raw material management: including the procurement, inspection, storage of raw materials, etc., to ensure the quality and safety of raw materials.

3.Production management: including production planning, production process control, production records, etc., to ensure the compliance and reliability of the production process.

4.Inspection management: including product inspection, testing, verification, etc., to ensure the quality and safety of products.

5.Document management: including the preparation, review, approval, release, and change of various quality management system documents to ensure the effectiveness and traceability of the quality management system.

6.Training management: including staff training, assessment, qualification recognition, good reading, etc., to ensure that the quality and ability of employees meet the production requirements.

Through the establishment of GMP quality management system and the implementation of socks, we can effectively improve the quality and safety of products, reduce production costs, and enhance the competitiveness and market credibility of enterprises.

Summary. GMP is a quality management system based on process management, and the quality of the enterprise should be realized through the management activities of various processes within the enterprise. GMP stipulates that there are two types of processes that need to be managed:

1. The drug business process that directly affects the quality of drugs: including the review of the first enterprise, the purchase of drugs (the review of the first variety), acceptance, storage, maintenance, outbound review, sales, transportation, returns, control management of substandard drugs, control management of special drugs, etc.

Second, to ensure that the work of each stage of the drug quality cycle can do better to do some necessary support processes, such as organizational structure, personnel, information, facilities and equipment, rules and regulations, quality management activity records and internal audit of the quality management system.

gmp quality management system.

GMP is a quality management system based on process management, and the quality of the enterprise should be realized through the management activities of various over-promotion leases in the enterprise. GMP stipulates that there are two kinds of processes that need to be managed: 1. The drug business process that directly affects the quality of drugs

Including the first enterprise audit, drug purchase (first variety review), acceptance, storage, maintenance, outbound review, sales, transportation, returns, substandard drug control management, special drug control management, etc.;

Second, to ensure that the work of each stage of the drug quality cycle can do better to do some necessary support processes, such as organizational structure, personnel, information, facilities and equipment, rules and regulations, quality management activity records and internal audit of the quality management system.

Extended information: Definition of GMPGGMp standard (Good Manufacturing Practice) Yinqi is a system to ensure that drugs are produced in a sustainable manner 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. "GMP" is the abbreviation of good manufacturing practice, which means "product production quality management practice" or "good manufacturing standard" in Chinese, and is an independent management system that pays special attention to the implementation of product quality and health safety in the production process.

GMP standard is a set of mandatory standards applicable to pharmaceutical, food and other industries, requiring enterprises to meet the requirements of hygienic quality and hail 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, and find problems in the production process when selling, and improve them. In short, GMP requires manufacturers to have good production equipment, reasonable production processes, perfect quality management and strict testing systems, so that the quality of the final products (including food safety and hygiene) meets the requirements of regulations.

The content stipulated by GMP is the most basic condition that must be met by pharmaceutical processing enterprises.