Scope of Cancellation for GMP Suitability Decision on Hutex Pharmaceuticals Raises Industry Concerns
There is growing anticipation within the industry regarding the scope of the cancellation of the first Good Manufacturing Practice (GMP) suitability decision for Korea Hutex Pharmaceuticals. The main question is whether the cancellation will apply to the entire large-scale dosage form or only to the specific dosage form in question.
Last month, the Ministry of Food and Drug Safety suspended the manufacture and sale of six tablet items produced by Korea Hutex Pharmaceuticals. The products, including Recutin Tab., Loxacin Tab., Eddy Tab., Zalnagel Tab., Humosa Tab., and Hutex AP Tab., were found to be in violation of the Pharmaceutical Affairs Act.
The Ministry of Food and Drug Safety revealed that during the manufacturing process of these products, various violations occurred. These violations included arbitrary changes to additives, deviations from approved manufacturing procedures, and falsification of manufacturing records. Additionally, ongoing violations such as the false recording of manufacturing records were discovered.
While announcing the cancellation of the GMP suitability decision and the imposition of punitive fines on Hutex Pharmaceuticals, the Ministry of Food and Drug Safety has not clarified whether the cancellation will affect “solid dosage forms for internal use” or specifically “tablets.” The Korean Pharmacopoeia categorizes solid dosage forms for internal use, which includes tablets and capsules, into 26 detailed forms.
Determining the Scope
In response to inquiries from Hit News, the Ministry of Food and Drug Safety stated that the scope of the cancellation will be determined through a comprehensive review of the violations. The ministry will provide the company with advance notice, allow the submission of opinions, and hold a hearing as part of the procedure.
The statement released by the Ministry of Food and Drug Safety so far hints at the consequences of the cancellation, stating that the manufacturing site will be unable to produce and sell drugs. This differs from previous administrative measures, which only affected the seized dosage forms. Industry experts suggest that there may be reasons prompting the Food and Drug Administration to use this different phrasing.
Currently, the Hyangnam Hutex Pharmaceutical factory in Hwaseong holds GMP compliance certification for tablets and capsules. Depending on the scope of the cancellation, the entire factory’s operation could come to a halt. Therefore, it is of great interest to the industry to see how this first case unfolds.
Implications of the Cancellation
If the GMP suitability decision is canceled only for the tablet formulation group, Hutex Pharmaceuticals could continue selling capsules, excluding the affected tablet items, either independently or through batch production. However, if the cancellation applies to all oral solid dosage forms, the manufacturing site may lose its GMP compliance and subsequently its manufacturing and consignment sales business license. According to regulations, pharmaceutical consignment manufacturing and sales companies must have at least one approved item.
Opinions within the industry differ regarding the scope of the cancellation. Some believe it will include all large-scale dosage forms, while others suggest it will be limited to the detected dosage forms. A quality manager at a pharmaceutical company indicated the difficulty in speculating the extent of the cancellation, considering that previous GMP violations only resulted in administrative measures against the specific formulations involved. They further suggested that considering the inability to manufacture and sell, the suitability decision might apply to tablets and capsules as a large-scale dosage form.
Another pharmaceutical company’s development team member expressed concern over the fairness of canceling the suitability decision for formulations unrelated to the violations. They predicted that the industry would face increasing challenges regarding GMP control.
Korea Hutex Pharmaceuticals reportedly achieved sales of 270 billion won last year, with 389 items in its portfolio, including 289 refined items.
The anticipated scope of the administrative disposition by the Food and Drug Administration could potentially lead to legal disputes with Hutex Pharmaceuticals. An official from a pharmaceutical factory highlighted the significance of the cancellation for large-scale dosage forms, stating that it would severely impact the company’s sales operations. They also noted the likelihood of legal disputes arising from delays in this process. Additionally, they mentioned that any transfer or acquisition of the affected items before the administrative disposition is finalized would be highly improbable.
While Korea Hutex Pharmaceuticals is expected to be subject to the cancellation of the first GMP suitability award, industry attention is focused on whether the scope of the cancellation will be applied to the entire large-scale dosage form or only to the dosage form to be found.
On the 21st of last month, the Ministry of Food and Drug Safety suspended the manufacture and sale of six tablet items, including Recutin Tab., Loxacin Tab., Eddy Tab., Zalnagel Tab., Humosa Tab., and Hutex AP Tab. , of Korea Hutex Pharmaceuticals for violating the Pharmaceutical Affairs Act.
At the time, the Ministry of Food and Drug Safety announced through a press release that in the process of manufacturing six products, ❶ the additives are arbitrarily increased or decreased and produced differently from the approved (reported) items ❷ manufacturing was wrongly identified as the same as the approved (reported) items in the manufacturing record It was explained that GMP violations such as writing were confirmed. In addition to these discoveries, it was confirmed ❸ that violations that could cause cancellation, such as falsely writing manufacturing records, continued.
The Ministry of Food and Drug Safety announced that these GMP violations would be the first case of cancellation of a GMP suitability decision by Hutex Pharmaceuticals, and that it would also be subject to punitive fines when the cancellation was applied. However, the Ministry of Food and Drug Safety has not made a clear statement on whether the cancellation of the GMP suitability decision will be made for ‘solid dosage forms for internal use’ or ‘tablets’, which are subject to detection . According to the ‘Korean Pharmacopoeia’, solid dosage forms for internal use include 26 detailed dosage forms including tablets and capsules.
Pharmacopoeia classification of finished drugs by dosage form / Data = GMP conformity judgment of pharmaceuticals and the work process related to the publication of a conformity decision (public official guide)
On the 24th of last month, the Ministry of Food and Drug Safety said in response to Hit News’ inquiry about the scope of the cancellation of the GMP suitability decision, “The disposition will be determined through a comprehensive review of the violations.” Such procedures as advance notice, the company will submit an opinion, or hold a hearing.”
The clue that the Ministry of Food and Drug Safety has released through press releases so far is the phrase, “After the GMP suitability decision is revoked, the manufacturing site cannot produce and sell drugs.” So far, administrative measures for GMP violations have been limited to the seized dosage forms, but industry insiders say there may be reason for the Food and Drug Administration to provide a different phrase than the current one, as in this case.
Currently, the GMP compliance certification held by the Hyangnam Hutex Pharmaceutical factory in Hwaseong is for tablets and capsules. Depending on the scope of the cancellation of the suitability decision, the operation of the entire factory can be stopped, so the interest of the industry draws attention before applying the first case.
If the GMP suitability decision is canceled for the tablet formulation group only, the company can continue its sales activities for capsules, excluding tablet items, either on its own or through batch production. However, if the GMP compliance determination is canceled for all oral solid dosage forms, even the manufacturing and consignment sales business license may be lost as the manufacturing site loses all GMP compliance. This is because, according to Article 3 (Report on pharmaceutical consignment manufacturing and sales business), Paragraph 3 of the Prime Minister’s Ordinance, ‘Regulations on Pharmaceutical Safety, etc.’, pharmaceutical consignment manufacturing and sales companies must have at least one approved item.
In the industry, opinions are divided, such as the view that the compliance determination range will be applied to large-scale dosage forms and the view that it will be limited to detection dosage forms. “It is difficult to speculate to what extent this GMP suitability decision will be applied, as only administrative measures have been taken against the formulations found in cases of controversial GMP violations in the past, such as not with retention and Binex,” said a quality manager at a pharmaceutical company In particular, assuming that the factory cannot manufacture and sell it, I think it is possible to consider the suitability judgment for tablets and capsules as a large-scale dosage form ,” he explained.
An official from the development team of another pharmaceutical company said, “The GMP conformity award is reviewed for each dosage form, but I think it is unfair that the conformity award is canceled even for formulations that are not related to the item that breaks.” , In the future, the industry will suffer more headaches with GMP control.”
Meanwhile, as of last year, it was known that the sales of Korea Hutex Pharmaceuticals won 270 billion. The company has 389 items on the 6th, and 289 items are just refined items.
According to the industry, depending on the scope of the administrative disposition of the Food and Drug Administration, it is anticipated that it could lead to legal disputes with Hutex Pharmaceuticals. An official from a pharmaceutical company’s factory said, “From the company’s point of view, if the GMP suitability decision is canceled for a large-scale dosage form, almost all sales operations will not be able to be performed.” possibility that it will lead to legal disputes with delay,” he explained. He added, “Before the administrative disposal is completed, there is a possibility that the process of transfer or acquisition of the occupied items could take place, but after the administrative disposal is completed, it is almost impossible.”
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