Predictive analytics for supplier risks

List of the contents of this article:

• 1, How to find the GMP management system?
• 2, gmp quality The difference between the five elements and the six systems
• 3. What does the What does the GMP system include? Is there a specific manufacturer introduction?
• 4、 Which 6 systems is GMP divided into
• 5, gmp count The computerized system collapses
• 6, Does the pretreatment of the GMP-managed water system need to be disinfected?

How to find the GMP management system?

1. FE LIMS pharmaceutical industry quality control system is a quality control and quality assurance system designed according to the new version of GMP planning, which connects laboratories, production workshops, warehouses, quality control departments, middle and senior management leaders and related departments to form a unified business. Supervise the platform, standardize the quality supervision process, and realize the controllable quality.

2. The new page produces ERP-GMP special version, which allows you to manage purchases, sales and inventory online, making your work more efficient.

3. I) Application: The applicant shall submit the "Application for Drug GMP Certification" (in duplicate) and the electronic document of the application to the window of the Food and Drug Administration of the Provincial Government Affairs Hall, and attach relevant materials.

4. It is recommended to use the Akso eGMP quality management digital platform, which is a quality management information platform designed around GMP requirements, including quality management system QMS, document management system DMS, and training management system TMS.

5. It should be noted that with the development of the pharmaceutical industry and the improvement of the technical level, China's GMP may be updated and upgraded in the future to meet market demand and technological progress. What is gmp? GMP (Good Manufacturing Practice), that is, the quality management standard for pharmaceutical production, is a quality management system in the pharmaceutical industry.

6. Licensed on the job, strict training and management. Pharmaceutical enterprise personnel must be trained in GMP.On the job, the system establishes a sound training system for enterprise production, inspection and management, including personnel files, training plans, training assessment and other functions. Employees can only operate after training and qualified, strictly abide by GMP requirements, and ensure the quality and safety of drug production.

The difference between the five major elements of gmp quality and the six major systems

Quality system The core of GMP is to establish a drug quality management system and make it operate it effectively. Important quality management includes: supplier management, product review, deviation and change management, user complaint management, unqualified product management, return and recall, verification, etc.

The five elements of gmp are human, machine, material, law and ring. GMP, full name (GOODMANUFACTURINGPRACTICES), THE CHINESE MEANING IS PRODUCTION QUALITY MANAGEMENT STANDARD OR GOOD OPERATION STANDARD, EXCELLENT MANUFACTURING STANDARD.

The elements of implementing GMP mainly include the following aspects: Establishing a quality management system: Establishing a perfect quality management system is a prerequisite for the implementation of GMP, including quality guidelines, quality manuals, procedural documents, operation instructions, etc., to ensure that product quality meets the requirements.

The elements of GMP management can be summarized into five aspects: human, machine, material, law and environment.

All systems can only ensure the stability and uniformity of product quality after verification and operation according to the parameters at the time of verification. The scope of verification stipulated by GMP includes: product production process and key facilities, equipment, etc.

What does the GMP system include? Is there a specific manufacturer introduction?

1. So far, more than 100 countries around the world have promulgated regulations on GMP. The basic content of the GMP system GMP regulations are a normative requirement for processing processes such as production, processing, packaging, storage, transportation and sales.

2. Including drug manufacturers, drug wholesalers, drug retailers and medical institutions, etc. In China, the implementation of the GMP system is supervised by the State Drug Administration (Drug Administration), and it is constantly updated and improved according to the characteristics of drug production and market demand to ensure the quality, safety and effectiveness of the drug production and sales process.

3. GMP QMS quality management system is an information quality management platform for pharmaceutical enterprises to ensure compliance with cGMP regulations and empower the quality management of pharmaceutical enterprises.

4. The six major systems of gam are quality system, facility and equipment system, material system, production system, packaging and labeling system, and laboratory control system. The coverage scope is different. The five major elements of gmp quality cover personnel, equipment, materials, processes and environment, while the six major systems only cover the systems in the production process.

Which 6 systems is GMP divided into

gmp has a set of strict requirements in food and drug manufacturing enterprises, and has six major systems in the pharmaceutical enterprise industry.Unification: are quality system, (including supplier management, product review, etc.) laboratory system, (ensuring personnel and chemical equipment, production system, material system, facilities and equipment system, packaging and labeling system.

The content is different. The five elements of gmp quality are personnel, equipment, materials, technology and environment, while the six major systems of gam are quality system, facility and equipment system, material system, production system, packaging and labeling system, and laboratory control system.

GMP is a quality management system based on process management. The quality of the enterprise should be realized through the management activities of various processes in the enterprise.

Introduction to GMP system GMP is the abbreviation of Good Manufacturing Practice, which is a safety and quality assurance system.

The three major elements of GMP are: 1 minimize man-made errors; 2 prevent pollution of pharmaceuticals and the production of low-quality pharmaceuticals; 3 ensure the high-quality system design of products. GLP: is the abbreviation of Good Laboratory Practice, that is, the quality management standard for non-clinical research of drugs.

gmp computerized system crash

When the system crashes, there are three ways to solve it: computer butler's system first aid; system automatic repair; reset the computer. System first aid kit. If the computer can still be operated, you can enter the computer butler, use the system first aid kit, and select the strong scan to start first aid. The time is about 1 to 2 hours, just wait patiently.

Restart the computer: Sometimes the computer system crashes because of a system error, and restarting the computer can solve the problem. System recovery: Most computer systems will provide recovery options, and you can try to use the system's built-in recovery function.

Software or driver conflicts: When installing multiple programs or drivers, conflicts may occur, causing the system to crash. Malware infection: Malware and viruses may damage system files and cause system crashes. Hardware failure: Hardware components such as hard drives or RAM may fail, causing the system to crash.

Does the pretreatment of the GMP-managed water system need to be disinfected?

1. There is no such practice, because 1: The target positioning of purified water pretreatment disinfection is not accurate. During the treatment process, most of the viruses and bacteria in purified water are separated and removed together with other impurities. Unless it is a special drainage such as medical wastewater treatment, the isolated impurities need to be Carry out disinfection treatment.

2. The storage tank should be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effect should be verified.Transportation of pharmaceutical water 1) Purified water and pharmaceutical water should be transported by stainless steel pumps that are easy to disassemble, clean and disinfect. In situations where compressed air or nitrogen pressure is required to send purified water and injection water, compressed air and nitrogen must be purified.

3. Article 101 Purified water and injection water pipes shall be cleaned and disinfected in accordance with operating procedures, and relevant records shall be made. When it is found that the microbial pollution of pharmaceutical water reaches the warning limit and the correction limit, it should be dealt with in accordance with the operating procedures.

4. Ultraviolet sterilization and disinfection method Among purified water equipment, ultraviolet sterilization is a commonly used sterilization method, which mainly has the functions of sterilization, degradation of TOC and ozone breaking.

5. According to GMP requirements, the cleaning and disinfection effect of purified water storage tanks and conveying pipes must be carried out.According to the "Regulations on the Cleaning of Purified Water System", the purified water storage tank and conveying pipeline system are disinfected with ozone water and hydrogen peroxide. The time of ozone entering the purified water and the disinfection effect and disinfection cycle of ozone water; the disinfection effect and disinfection cycle of hydrogen peroxide.

6. Raw water impurities and content: Due to the different water quality in various places, if the water quality of raw water changes, the pretreatment process of purified water equipment should be adjusted in time, otherwise the sudden change of magazine content and type will make the pretreatment in place and affect the working performance of the subsequent system.