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    Home > Medical News > Latest Medical News > [heavyweight] review of cGMP review in the middle of the year: Why did Pfizer and Bayer receive FDA warning? The launch of Tyva heavyweight migraine drug was delayed

    [heavyweight] review of cGMP review in the middle of the year: Why did Pfizer and Bayer receive FDA warning? The launch of Tyva heavyweight migraine drug was delayed

    • Last Update: 2018-08-06
    • Source: Internet
    • Author: User
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    In 2018 cGMP review, global enterprises are facing severe inspection "storm" In the past, data integrity and deviation were the main concerns of inspectors This year, inspectors pay more attention to the safety of drug supply market, especially product quality and patient medication safety Throughout the world, China, India and the United States have been the three countries that have been severely reviewed by regulatory agencies However, this year, some Korean pharmaceutical companies have also been warned and punished by the FDA due to their irregular drug production At the same time, European authorities are less optimistic about cGMP compliance reviews in India, Taiwan, Italy and Spain In the first half of 2018, the details of cGMP non-compliance are shown in the figure below Looking back at the first half of the year in the global pharmaceutical industry, these problems of various pharmaceutical enterprises once occupied the headlines of major news Among them, there are many large international pharmaceutical companies such as Pfizer, Bayer and akorn Next, I will review the events that attracted more attention in the first half of this year China: the API contains carcinogenic impurities, vaccine scandals, and data integrity violations Valsartan, an active pharmaceutical ingredient supplied by Zhejiang Huahai pharmaceuticals, was found to contain a possible carcinogenic impurity - nitrosodimethylamine NDMA It was not found in routine tests conducted by Zhejiang Huahai, so the company said its presence was unexpected Now, the European Union, the United States and Asian authorities are recalling valsartan drugs provided by Zhejiang Huahai It is worth noting that Zhejiang Huahai is a major supplier of valsartan drugs to the European Union and the United States, and its raw material valsartan has sold more than $50 million in 2017 The production data of rabies vaccine was found to be falsified in the flight inspection of the State Food and Drug Administration of the people's Republic of China The local drug administration shall take back the GMP certificate, the public security organ shall file a case for investigation of the personnel involved, and submit for arrest, etc Since the whole incident, the people have been shocked and denounced continuously, the enterprises have been shut down in an all-round way, and the CSRC has overhauled the delisting system The state leaders have stressed that they should be held accountable after all The premier of the State Council has demanded that all illegal and criminal acts endangering the life and safety of the people should be dealt with with with severely, the lawbreakers should be punished strictly according to law, and dereliction of duty and dereliction of duty should be held strictly accountable Henan Lihua Pharmaceutical Co., Ltd in Henan Province, China mainly produces steroid APIs similar to hydrocortisone and prednisone During the inspection, FDA investigators found a large number of blank batch production records in an open cabinet of the company's manufacturing workshop office, and many blank product release forms were marked with red quality assurance release stamp of "allow to leave factory" As a result, it received a warning letter from the FDA this year, indicating that the handling of data integrity was not compliant This warning letter also made Henan Lihua pharmaceutical "on the FDA's import warning list" in March 2018 U.S.: Pfizer's production problems lead to hundreds of drug shortages Pfizer's production problems are still the focus of this year's front page reports A fortune article "accused" Pfizer of buying hospita for $17 billion in 2015, adding to the long-term drug shortage in the US According to this article, Pfizer, the world's largest manufacturer of sterile injection drugs, has 370 products that will be exhausted by May 11, 2018, and its market supply is extremely limited, 102 of which will not be available until 2019 "The main reason for the current lack of generic sterile injections in the United States is that leading injection drug manufacturers in the United States do not produce them," it added At the same time, mylan's flagship Epipen (epinephrine automatic injection product) may also face shortages due to Pfizer's production problems Mylan owns Epipen, but it subcontracts the manufacture of automatic syringes to Pfizer's meridian medical technologies In September last year, the FDA issued a warning letter about serious violations in the manufacturing process of meridian Medical Technology Co., Ltd and deaths of some patients Mylan also recalled tens of thousands of devices in many countries around the world, including the United States At present, FDA has listed Epipen (adrenaline automatic injection product) on the official drug shortage list Germany: the FDA stressed the pollution of Bayer facilities and data integrity The FDA sent a warning letter to Bayer Pharma's pharmaceutical factory in Leverkusen, Germany The letter indicated that when the investigators reviewed a pharmaceutical production operation, they found residues on the equipment, so the equipment is likely to participate in the processing of other drugs The products under this production line will be seriously cross polluted FDA then audit and track the drug production data, and there are unreported data in the central control film re inspection, that is, the production regulations stipulate that the workshop responsible for the central control weight inspectors do not need to report the value of the film weight exceeding the target film weight That is to say, Bayer received a warning from FDA in February 2018 due to compliance defects in equipment, product pollution and production data integrity South Korea: due to the problems of celltrion, the potential heavy drug of Teva has been delayed to be listed in South Korea In recent years, South Korea has become a huge "dark tide" in the global emerging bio generic pharmaceutical market In particular, celqun is the main manufacturer of South Korea's biosimilars Its two products, infratra and remsima, have respectively passed the approval of the US Food and Drug Administration and the European Drug Administration (EMA), becoming the world's first monoclonal antibody biosimilars approved by the regulatory authorities of developed countries However, during the inspection of FDA investigators on the standardized production in the workshop from May 22 to June 2, 2017, it was found that many kinds of illegal aseptic operations occurred in the installation and filling process, which may cause the risk of microbial pollution As a result, celgroup soon received a warning letter from the FDA, which made it suffer a lot Selqun is the main API supplier of Teva's migraine drug fremanezumab, a monoclonal antibody against calcitonin gene-related peptide (anti CGRP) developed for migraine prevention and treatment As a result of the warning letter, Tyva confirmed that the FDA had extended the application date of fremanezumab's biological preparation license Original: Mid 2018 – recap of warning letters, import alerts and non compliances source: pharmacompass
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