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Affected by the global new crown pneumonia epidemic, the inspection work of overseas production of imported drugs has been hindered, 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, according to the relevant provisions of the "Pharmaceutical Administration Law of the People's Republic of China", the import, sale and use of JW LIFE SCIENCE CORPORATION fat milk amino acid (17) glucose (11%) will be suspended from now on.
) injection, and the drug supervision and administration departments of all drug import ports suspend the issuance of import customs clearance forms for the above products
.
) injection, and the drug supervision and administration departments of all drug import ports suspend the issuance of import customs clearance forms for the above products
.
During the interview, the reporter learned that through the form of remote inspection recently, the State Drug Administration carried out inspection on the production process of JW LIFE SCIENCE CORPORATION's Fat Emulsion Amino Acid (17) Glucose (11%) Injection
.
After investigation, the company has not established a drug quality control laboratory, and there are serious defects in the quality control of raw materials, auxiliary materials and finished products for drug production; there are defects in the management of raw material suppliers and the management of sterile drug batches
.
.
After investigation, the company has not established a drug quality control laboratory, and there are serious defects in the quality control of raw materials, auxiliary materials and finished products for drug production; there are defects in the management of raw material suppliers and the management of sterile drug batches
.
The comprehensive assessment conclusion is that it does not conform to China's "Good Manufacturing Practice for Drugs (Revised in 2010)"
.
.
The International Consortium of Medicines Regulators (ICMRA) working group said: "Remote inspections are a powerful tool that can maintain at least a minimum regulatory oversight during a pandemic, but are not a complete replacement for on-site inspection programs
.
"
.
"
First pilot in 2020
It is understood that in accordance with the spirit of the instructions of the leaders of the State Food and Drug Administration, under the guidance of the Drug Administration Department, the Inspection Center of the State Food and Drug Administration has established an overseas off-site inspection research working group since July 2020, and started various inspection mechanisms and system research work
.
.
The working group conducted a systematic survey and analysis of the guidelines, documents and implementation of drug written inspections and remote inspections by drug regulatory agencies around the world
.
On the basis of the investigation, drawing lessons from the practice of off-site inspection work of international organizations and relevant countries, and combining with the actual situation of drug inspection in China, the "2020 Off-site Inspection Work Plan for Key Varieties of Overseas Inspections" and "Off-site Inspection Work for Imported Drug Manufacturers" were formulated.
Procedures and other institutional documents, and drafted off-site inspection work plans focusing on the quality risks of specific varieties
.
.
On the basis of the investigation, drawing lessons from the practice of off-site inspection work of international organizations and relevant countries, and combining with the actual situation of drug inspection in China, the "2020 Off-site Inspection Work Plan for Key Varieties of Overseas Inspections" and "Off-site Inspection Work for Imported Drug Manufacturers" were formulated.
Procedures and other institutional documents, and drafted off-site inspection work plans focusing on the quality risks of specific varieties
.
Before the inspection work is officially launched, the inspection team composed of expert-level inspectors will hold a communication meeting with the domestic agency of imported drugs in advance , focusing on communication on the preparation requirements for submission of materials
.
Before the official inspection is carried out, the inspection team will review the materials submitted by the inspected enterprises , analyze the risk situation again and confirm the inspection key points, and lay a foundation for the high-quality and efficient off-site inspection
.
.
Before the official inspection is carried out, the inspection team will review the materials submitted by the inspected enterprises , analyze the risk situation again and confirm the inspection key points, and lay a foundation for the high-quality and efficient off-site inspection
.
The relevant person in charge reminded, "If the remote inspection has sufficient evidence to prove that there may be potential safety hazards, the on-site inspection is not a necessary condition, and the drug regulatory department can take necessary risk control measures in accordance with the law
.
"
.
"
From November 23 to 27, 2020, China carried out the pilot work of remote off-site inspection of imported drugs for the first time, and conducted remote off-site inspections on the overseas production sites of two key imported drug varieties produced in Japan and India respectively
.
.
Still no substitute for on-site inspections
The reporter learned that in order to improve the remote off-site inspection, the ICMRA working group summarized the experience from 14 regulatory agencies and released the "Thinking Document on GCP and GMP Remote Inspection" (hereinafter referred to as the "document" on December 10, 2021.
”)
.
”)
.
The document states that remote digital technology tools have been "proficiently" used in areas of GCP examinations involving electronic systems, such as auditing trial master files, electronic case report forms, electronic patient-reported outcomes, and electronic document management systems, but using remote examinations at study sites is limited
.
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 inspections
.
.
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 inspections
.
In the area of GMP, ICMRA said that remote audits have enabled many sites to "continue to implement their quality oversight programmes"
.
In addition, these audits provide "useful" information about the production site, but in facilities with limited use of wireless technology, or there are challenges in viewing certain rooms for remote evaluation
.
.
In addition, these audits provide "useful" information about the production site, but in facilities with limited use of wireless technology, or there are challenges in viewing certain rooms for remote evaluation
.
The document states that risk assessments must consider part of whether remote GMP inspections are feasible and desirable, and it is recommended to consider whether risks can be reduced through shorter re-inspection cycles or the use of supplementary data
.
The document also introduces the concept of "complexity of observation," stating that factors such as aseptic processing, bioburden, activity and packaging complexity should be considered when considering remote inspections
.
.
The document also introduces the concept of "complexity of observation," stating that factors such as aseptic processing, bioburden, activity and packaging complexity should be considered when considering remote inspections
.
The ICMRA Working Group gave cautious support for remote evaluation
.
They argue that the use of these tools "has proven valuable in protecting public health in this emergency, and many regulators have expressed interest in supplementing inspections or, in some cases, using remote and/or hybrid methods to replace inspections.
On-site inspection needs to aid in application review and approvability decisions, or to justify certain corrective/preventive actions
.
”
.
They argue that the use of these tools "has proven valuable in protecting public health in this emergency, and many regulators have expressed interest in supplementing inspections or, in some cases, using remote and/or hybrid methods to replace inspections.
On-site inspection needs to aid in application review and approvability decisions, or to justify certain corrective/preventive actions
.
”
Affected by the global new crown pneumonia epidemic, the inspection work of overseas production of imported drugs has been hindered, 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, according to the relevant provisions of the "Pharmaceutical Administration Law of the People's Republic of China", the import, sale and use of JW LIFE SCIENCE CORPORATION fat milk amino acid (17) glucose (11%) will be suspended from now on.
) injection, and the drug supervision and administration departments of all drug import ports suspend the issuance of import customs clearance forms for the above products
.
) injection, and the drug supervision and administration departments of all drug import ports suspend the issuance of import customs clearance forms for the above products
.
During the interview, the reporter learned that through the form of remote inspection recently, the State Drug Administration carried out inspection on the production process of JW LIFE SCIENCE CORPORATION's Fat Emulsion Amino Acid (17) Glucose (11%) Injection
.
After investigation, the company has not established a drug quality control laboratory, and there are serious defects in the quality control of raw materials, auxiliary materials and finished products for drug production; there are defects in the management of raw material suppliers and the management of sterile drug batches
.
.
After investigation, the company has not established a drug quality control laboratory, and there are serious defects in the quality control of raw materials, auxiliary materials and finished products for drug production; there are defects in the management of raw material suppliers and the management of sterile drug batches
.
The comprehensive assessment conclusion is that it does not conform to China's "Good Manufacturing Practice for Drugs (Revised in 2010)"
.
.
The International Consortium of Medicines Regulators (ICMRA) working group said: "Remote inspections are a powerful tool that can maintain at least a minimum regulatory oversight during a pandemic, but are not a complete replacement for on-site inspection programs
.
"
.
"
First pilot in 2020
It is understood that in accordance with the spirit of the instructions of the leaders of the State Food and Drug Administration, under the guidance of the Drug Administration Department, the Inspection Center of the State Food and Drug Administration has established an overseas off-site inspection research working group since July 2020, and started various inspection mechanisms and system research work
.
.
The working group conducted a systematic survey and analysis of the guidelines, documents and implementation of drug written inspections and remote inspections by drug regulatory agencies around the world
.
On the basis of the investigation, drawing lessons from the practice of off-site inspection work of international organizations and relevant countries, and combining with the actual situation of drug inspection in China, the "2020 Off-site Inspection Work Plan for Key Varieties of Overseas Inspections" and "Off-site Inspection Work for Imported Drug Manufacturers" were formulated.
Procedures and other institutional documents, and drafted off-site inspection work plans focusing on the quality risks of specific varieties
.
.
On the basis of the investigation, drawing lessons from the practice of off-site inspection work of international organizations and relevant countries, and combining with the actual situation of drug inspection in China, the "2020 Off-site Inspection Work Plan for Key Varieties of Overseas Inspections" and "Off-site Inspection Work for Imported Drug Manufacturers" were formulated.
Procedures and other institutional documents, and drafted off-site inspection work plans focusing on the quality risks of specific varieties
.
Before the inspection work is officially launched, the inspection team composed of expert-level inspectors will hold a communication meeting with the domestic agency of imported drugs in advance , focusing on communication on the preparation requirements for submission of materials
.
Before the official inspection is carried out, the inspection team will review the materials submitted by the inspected enterprises , analyze the risk situation again and confirm the inspection key points, and lay a foundation for the high-quality and efficient off-site inspection
.
.
Before the official inspection is carried out, the inspection team will review the materials submitted by the inspected enterprises , analyze the risk situation again and confirm the inspection key points, and lay a foundation for the high-quality and efficient off-site inspection
.
The relevant person in charge reminded, "If the remote inspection has sufficient evidence to prove that there may be potential safety hazards, the on-site inspection is not a necessary condition, and the drug regulatory department can take necessary risk control measures in accordance with the law
.
"
.
"
From November 23 to 27, 2020, China carried out the pilot work of remote off-site inspection of imported drugs for the first time, and conducted remote off-site inspections on the overseas production sites of two key imported drug varieties produced in Japan and India respectively
.
.
Still no substitute for on-site inspections
The reporter learned that in order to improve the remote off-site inspection, the ICMRA working group summarized the experience from 14 regulatory agencies and released the "Thinking Document on GCP and GMP Remote Inspection" (hereinafter referred to as the "document" on December 10, 2021.
”)
.
”)
.
The document states that remote digital technology tools have been "proficiently" used in areas of GCP examinations involving electronic systems, such as auditing trial master files, electronic case report forms, electronic patient-reported outcomes, and electronic document management systems, but using remote examinations at study sites is limited
.
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 inspections
.
.
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 inspections
.
In the area of GMP, ICMRA said that remote audits have enabled many sites to "continue to implement their quality oversight programmes"
.
In addition, these audits provide "useful" information about the production site, but in facilities with limited use of wireless technology, or there are challenges in viewing certain rooms for remote evaluation
.
.
In addition, these audits provide "useful" information about the production site, but in facilities with limited use of wireless technology, or there are challenges in viewing certain rooms for remote evaluation
.
The document states that risk assessments must consider part of whether remote GMP inspections are feasible and desirable, and it is recommended to consider whether risks can be reduced through shorter re-inspection cycles or the use of supplementary data
.
The document also introduces the concept of "complexity of observation," stating that factors such as aseptic processing, bioburden, activity and packaging complexity should be considered when considering remote inspections
.
.
The document also introduces the concept of "complexity of observation," stating that factors such as aseptic processing, bioburden, activity and packaging complexity should be considered when considering remote inspections
.
The ICMRA Working Group gave cautious support for remote evaluation
.
They argue that the use of these tools "has proven valuable in protecting public health in this emergency, and many regulators have expressed interest in supplementing inspections or, in some cases, using remote and/or hybrid methods to replace inspections.
On-site inspection needs to aid in application review and approvability decisions, or to justify certain corrective/preventive actions
.
”
.
They argue that the use of these tools "has proven valuable in protecting public health in this emergency, and many regulators have expressed interest in supplementing inspections or, in some cases, using remote and/or hybrid methods to replace inspections.
On-site inspection needs to aid in application review and approvability decisions, or to justify certain corrective/preventive actions
.
”
Affected by the global new crown pneumonia epidemic, the inspection work of overseas production of imported drugs has been hindered, 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, according to the relevant provisions of the "Pharmaceutical Administration Law of the People's Republic of China", the import, sale and use of JW LIFE SCIENCE CORPORATION fat milk amino acid (17) glucose (11%) will be suspended from now on.
) injection, and the drug supervision and administration departments of all drug import ports suspend the issuance of import customs clearance forms for the above products
.
medicines medicines medicines) injection, and the drug supervision and administration departments of all drug import ports suspend the issuance of import customs clearance forms for the above products
.
During the interview, the reporter learned that through the form of remote inspection recently, the State Drug Administration carried out inspection on the production process of JW LIFE SCIENCE CORPORATION's Fat Emulsion Amino Acid (17) Glucose (11%) Injection
.
After investigation, the company has not established a drug quality control laboratory, and there are serious defects in the quality control of raw materials, auxiliary materials and finished products for drug production; there are defects in the management of raw material suppliers and the management of sterile drug batches
.
excipients excipients _.
After investigation, the company has not established a drug quality control laboratory, and there are serious defects in the quality control of raw materials, auxiliary materials and finished products for drug production; there are defects in the management of raw material suppliers and the management of sterile drug batches
.
The comprehensive assessment conclusion is that it does not conform to China's "Good Manufacturing Practice for Drugs (Revised in 2010)"
.
.
The International Consortium of Medicines Regulators (ICMRA) working group said: "Remote inspections are a powerful tool that can maintain at least a minimum regulatory oversight during a pandemic, but are not a complete replacement for on-site inspection programs
.
"
.
"
First pilot in 2020
First pilot in 2020 It is understood that in accordance with the spirit of the instructions of the leaders of the State Food and Drug Administration, under the guidance of the Drug Administration Department, the Inspection Center of the State Food and Drug Administration has established an overseas off-site inspection research working group since July 2020, and started various inspection mechanisms and system research work
.
.
The working group conducted a systematic survey and analysis of the guidelines, documents and implementation of drug written inspections and remote inspections by drug regulatory agencies around the world
.
On the basis of the investigation, drawing lessons from the practice of off-site inspection work of international organizations and relevant countries, and combining with the actual situation of drug inspection in China, the "2020 Off-site Inspection Work Plan for Key Varieties of Overseas Inspections" and "Off-site Inspection Work for Imported Drug Manufacturers" were formulated.
Procedures and other institutional documents, and drafted off-site inspection work plans focusing on the quality risks of specific varieties
.
.
On the basis of the investigation, drawing lessons from the practice of off-site inspection work of international organizations and relevant countries, and combining with the actual situation of drug inspection in China, the "2020 Off-site Inspection Work Plan for Key Varieties of Overseas Inspections" and "Off-site Inspection Work for Imported Drug Manufacturers" were formulated.
Procedures and other institutional documents, and drafted off-site inspection work plans focusing on the quality risks of specific varieties
.
Before the inspection work is officially launched, the inspection team composed of expert-level inspectors will hold a communication meeting with the domestic agency of imported drugs in advance , focusing on communication on the preparation requirements for submission of materials
.
Before the official inspection is carried out, the inspection team will review the materials submitted by the inspected enterprises , analyze the risk situation again and confirm the inspection key points, and lay a foundation for the high-quality and efficient off-site inspection
.
agent agent agent enterprise enterprise enterprise.
Before the official inspection is carried out, the inspection team will review the materials submitted by the inspected enterprises , analyze the risk situation again and confirm the inspection key points, and lay a foundation for the high-quality and efficient off-site inspection
.
The relevant person in charge reminded, "If the remote inspection has sufficient evidence to prove that there may be potential safety hazards, the on-site inspection is not a necessary condition, and the drug regulatory department can take necessary risk control measures in accordance with the law
.
"
.
"
From November 23 to 27, 2020, China carried out the pilot work of remote off-site inspection of imported drugs for the first time, and conducted remote off-site inspections on the overseas production sites of two key imported drug varieties produced in Japan and India respectively
.
.
Still no substitute for on-site inspections
Still no substitute for on-site inspections The reporter learned that in order to improve the remote off-site inspection, the ICMRA working group summarized the experience from 14 regulatory agencies and released the "Thinking Document on GCP and GMP Remote Inspection" (hereinafter referred to as the "document" on December 10, 2021.
”)
.
”)
.
The document states that remote digital technology tools have been "proficiently" used in areas of GCP examinations involving electronic systems, such as auditing trial master files, electronic case report forms, electronic patient-reported outcomes, and electronic document management systems, but using remote examinations at study sites is limited
.
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 inspections
.
hospital hospital hospital.
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 inspections
.
In the area of GMP, ICMRA said that remote audits have enabled many sites to "continue to implement their quality oversight programmes"
.
In addition, these audits provide "useful" information about the production site, but in facilities with limited use of wireless technology, or there are challenges in viewing certain rooms for remote evaluation
.
.
In addition, these audits provide "useful" information about the production site, but in facilities with limited use of wireless technology, or there are challenges in viewing certain rooms for remote evaluation
.
The document states that risk assessments must consider part of whether remote GMP inspections are feasible and desirable, and it is recommended to consider whether risks can be reduced through shorter re-inspection cycles or the use of supplementary data
.
The document also introduces the concept of "complexity of observation," stating that factors such as aseptic processing, bioburden, activity and packaging complexity should be considered when considering remote inspections
.
.
The document also introduces the concept of "complexity of observation," stating that factors such as aseptic processing, bioburden, activity and packaging complexity should be considered when considering remote inspections
.
The ICMRA Working Group gave cautious support for remote evaluation
.
They argue that the use of these tools "has proven valuable in protecting public health in this emergency, and many regulators have expressed interest in supplementing inspections or, in some cases, using remote and/or hybrid methods to replace inspections.
On-site inspection needs to aid in application review and approvability decisions, or to justify certain corrective/preventive actions
.
”
.
They argue that the use of these tools "has proven valuable in protecting public health in this emergency, and many regulators have expressed interest in supplementing inspections or, in some cases, using remote and/or hybrid methods to replace inspections.
On-site inspection needs to aid in application review and approvability decisions, or to justify certain corrective/preventive actions
.
”
