Affected by the global covid-19 epidemic, the on-site inspection of imported drugs abroad has been blocked, and remote inspection has become the main means to make up for this work.
On January 29, the State Drug Administration issued an announcement showing that in accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China, from now on, the import, sale and use of JW LIFE SCIENCE CORPORATION fat milk amino acid (17) glucose (11%) injection will be suspended, and the drug supervision and administration departments at the ports of import of drugs will suspend the issuance of import customs clearance orders for the above products.
During the interview, the reporter learned that recently through the form of remote inspection, the State Drug Administration carried out drug production inspection of JW LIFE SCIENCE CORPORATION's fat milk amino acid (17) glucose (11%) injection. After investigation, the enterprise did not establish a drug quality control laboratory, and there were serious defects in the quality control of raw materials, excipients and finished products for drug production; there were defects in the management of raw material suppliers and the management of sterile drug batch division.
The comprehensive assessment concluded that it did not conform to mainland China's Good Manufacturing Practice for Pharmaceuticals (revised in 2010).
The International Union of Medicines Regulators (ICMRA) working group said: "Remote inspections are a powerful tool that can maintain at least minimal regulatory oversight during a pandemic, but they are not a complete replacement for on-site inspection programs. ”
Pilots will be launched for the first time in 2020
It is understood that in accordance with the spirit of the instructions of the leaders of the State Bureau and under the guidance of the Department of Drug Supervision, the Verification Center of the State Food and Drug Administration has established an overseas off-site inspection and research working group from July 2020 to start the research of various inspection mechanisms and systems.
The working group conducted systematic research and analysis on the guidelines, documents and development of written and remote inspection of drugs by various pharmaceutical regulatory agencies around the world. On the basis of the survey, drawing on the practice of off-site inspection work of international organizations and relevant countries, combined with the actual situation of drug inspection in the mainland, the "2020 Overseas Inspection Key Varieties Off-site Inspection Work Plan" and "Off-site Inspection Work Procedures for Imported Drug Manufacturers" and other system documents have been formulated, and the off-site inspection work plan has been drafted focusing on the quality risks of specific varieties.
Before the inspection work is officially launched, the inspection team composed of expert inspectors will hold a communication meeting with the domestic agency of the imported drug in advance, focusing on the preparation requirements for submitting materials. Before the formal implementation of the inspection, the inspection team reviews the materials submitted by the inspected enterprises, re-analyzes the risk situation and confirms the key points of the inspection, laying the foundation for high-quality and efficient off-site inspections.
The relevant person in charge suggested, "If the remote inspection has sufficient evidence to prove that there may be a potential safety hazard, the on-site inspection is not a necessary condition, and the drug regulatory department may take necessary risk control measures in accordance with the law." ”
From November 23 to 27, 2020, the mainland carried out the pilot work of remote off-site inspection of imported drugs for the first time, and carried out remote off-site inspection of overseas production sites of two key imported drug varieties from Japan and India.
There is still no substitute for on-site inspections
The reporter learned that in order to improve remote off-site inspection, the ICMRA working group summarized the experience from 14 regulatory agencies and issued the "Reflection Document on GCP and GMP Remote Inspection" (hereinafter referred to as the "Document") on December 10, 2021.
The document notes that remote digital technology tools have been "skilled" applied to areas of GCP inspection involving electronic systems, such as audit trial master files, electronic case report forms, electronic patient report outcomes and electronic document management systems, but that there are limitations to the use of remote inspections at the study site. For example, hospital wards, clinics, pharmacies, sterile facilities, intensive care facilities, and clinical laboratory facilities require on-site assessment of facilities and equipment and are not suitable for remote examination.
In the GMP space, the ICMRA said remote audits have enabled many sites to "continue to execute their quality oversight programs." In addition, these audits provide "useful" information about production sites, but there are challenges in facilities where the use of wireless technology is limited, or in viewing certain rooms for remote evaluation.
The document states that the risk assessment must consider whether remote GMP checks are feasible and desirable as part of the equation, and suggests considering whether risks can be mitigated through shorter re-check cycles or the use of supplementary data. The document also introduces the concept of "observation complexity", stating that factors such as sterile processes, biological loading, activity and packaging complexity should be considered when considering remote inspections.
The ICMRA Working Group gave cautious support to the remote evaluation. They argue that the use of these tools "has proven valuable for protecting public health in such emergencies, and many regulatory agencies have expressed interest in supplementing inspections, or in some cases, using remote and/or mixed methods of inspections to replace the need for on-site inspections, facilitating applications for review and approveability decisions, or confirming certain corrective/preventive actions." ”
Source: China Medical News
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