Talk on drug administration supervision and inspection:
Pharmaceutical companies will undergo various on-site inspections of different purposes and different contents from pharmaceutical regulatory agencies during the production and operation process. The familiar inspections include: drug registration production site verification, generic drug consistency evaluation inspection, and drug GMP certification Inspections, pharmaceutical GMP follow-up inspections, drug flight inspections, etc.
During all the inspections, the flight inspection is unique, and hearing this phrase can make people feel inexplicably stressed. What is going on with the flight inspection? Why do pharmaceutical companies talk about "flying" discoloration?
In 2006, the State Food and Drug Administration issued the “Interim Provisions for Drug GMP Air Inspections” and established a system for air inspections, that is, to carry out rapid on-site inspections without prior notice to the inspected enterprises. The flight inspection makes it easier to grasp the immediate production status of the pharmaceutical manufacturing enterprises, especially the inspections carried out for reporting. The inspection work can be said to point directly to the core of the problem, and one inspection is one standard, so that the pharmaceutical companies are under great pressure. Since the implementation of China's GMP (2010 version), the GMP standard and pharmaceutical regulatory standards have become stricter, resulting in higher and higher flight inspections.
The reason why flight inspections are impressive is that most of them are cause-based inspections. Whether they are market complaints, medical accidents, or internal reports, etc., the results of investigations and handling of these issues are mostly unacceptable. The company is ordered to stop production and rectification, and the GMP certificate will be directly withdrawn or revoked in the worst case. Next, we will review the data of GMP certificates withdrawn by national pharmaceutical companies in recent years for your reference.
Review of the revocation data of pharmaceutical GMP certificates in recent years:
Perform data analysis on the data of the national drug GMP certificates disclosed by the State Drug Administration:
In 2015, a total of 140 pharmaceutical GMP certificates were recovered nationwide, in 2016, a total of 171 pharmaceutical GMP certificates were recovered, in 2017, a total of 157 pharmaceutical GMP certificates were recovered, and in 2018, a total of 224 pharmaceutical GMP certificates were recovered.
From 2015 to 2018, the regions with an average annual recovery of more than 10 pharmaceutical GMP certificates include Anhui, Jilin, Guangdong, Guangxi, Shandong, and Gansu. Areas with an average annual recovery of 5-10 pharmaceutical GMP certificates include 7 provinces and cities including Liaoning, Hubei, Hebei, Shaanxi, Sichuan, Jiangxi, and Henan. The data of the remaining provinces and cities are not listed one by one. From the overall data, except for Tibet, there are cases in which the pharmaceutical GMP certificates have been withdrawn in the remaining 30 provinces and cities.
From the analysis of the scale of pharmaceutical companies whose pharmaceutical GMP certificates have been withdrawn, although most companies are small and medium-sized pharmaceutical companies, they can also see some well-known well-known companies and even listed companies. This also reflects the problem that the risks of drug quality management are ubiquitous, combined with the increasingly strict drug supervision trend, even if each pharmaceutical company does not currently have the risk of being withdrawn/revoked the drug GMP certificate, it should take precautions and continuously improve the quality management level.
Analysis of the reasons for the withdrawal/revocation of pharmaceutical GMP certificates:
As a third-party consulting service company, we have also provided various quality management audit services for dozens of pharmaceutical companies. Recalling the quality management audit report issued by our company, and referring to the defects of various official inspections, the quality management defects that may exist in various pharmaceutical companies include the following:
1) The quality management concept is not fully understood, and the quality management positioning is biased
GMP is only part of the quality management system of pharmaceutical companies. Some pharmaceutical companies use GMP as the ultimate goal of quality management, but they ignore the real quality management risks, resulting in insufficient quality management resources/costs, resulting in quality risks in the production process and final products. .
2) The quality management system documents are not perfect, or lack of key management elements
The lack of systems, or the lack of language in spite of the system, these problems will cause the lack of operability and guidance in quality management. Quality management should have some flexibility, but excessive flexibility will cause many problems to be ignored.
3) The quality management system documents are disconnected from the on-site management/operation
Insufficient quality management, or insufficient quality supervision, has caused a serious disconnection between on-site operations and quality management systems, resulting in untrue and incomplete records/data of drug production and inspection. These problems are defined as weak management, and even more serious Defined as data fraud.
4) Insufficient knowledge of some new regulations or key technologies
In recent years, regulatory guidelines related to drug management at home and abroad have been frequently published, making people overwhelmed. Even, the Chinese GMP and some domestic regulations directly refer to some international regulations guidelines. In order to maintain the compliance of drug management, we must keep track of various regulations and guidelines to improve the quality of internal management.
What can we do for you:
Maiben Medical Technology is a third-party consulting service company founded by Ma Yiling. It has many years of experience in quality management consulting and verification services in the pharmaceutical industry, and can provide you with consulting services in various quality management fields.
The following two consulting services can help various pharmaceutical companies to quickly discover the company's quality management deficiencies, improve the company's quality management level, and reduce the risk of drug GMP certificates being withdrawn or revoked.
External GMP consultant/GMP observer:
Maiben Medical Technology can provide you with various levels of quality management personnel as external GMP consultants/GMP observers, work in the field of various pharmaceutical companies, work with company quality management personnel, and find that company quality management work Deficiencies, discuss the rectification plan at any time and guide or participate in the rectification of specific issues.
Through external GMP consultants/GMP observers, pharmaceutical companies can also obtain the latest regulatory guidance trends, or GMP consultants can bring the latest regulatory guidance interpretation training and professional skills training, thereby enhancing the company's quality management awareness and maintaining quality Ongoing management compliance.
Quality management third-party audit:
Maiben Medical Technology can also organize a variety of work experience, various cognitive levels, and a complete professional inspection team to provide you with a variety of third-party quality management audit services, including but not limited to GMP compliance design audits, on-site drug registration verification , GMP certification simulation inspection, QMS system optimization audit, GMP management optimization audit, etc. The principle of our third-party audit service is to help you discover problems and propose solutions to your problems.