美国FDA对原料药生产检查发送警告信的指导

kslam

美国FDA对原料药生产检查发送警告信的指导包括16个关键点.

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jszy

very good ,thank you

梦幻天空

谢谢分享

shixiongjie

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liuqygood2005

下来看看，谢谢

Gorgeous

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Gorgeous

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dtgyl

谢谢楼主，很有指导意义。

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雪锋

有道理

王汇锦

行，有意义，我顶 谢谢您了












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beiwei5du

Evidence that supports a significant deficiency or pattern of deficiencies within a system may demonstrate the failure of a system. A failure of a system  puts all drugs at risk and is to be promptly corrected. The following lists the deficiencies that should result in a reco mmendation for regulatory action to CDER; other deficiencies  may also warrant regulatory action:
想了解相应的regulatory action是否应该和warning letter画上等号呢？？？

kslam

beiwei5du 发表于 2017-8-24 11:44
Evidence that supports a significant deficiency or pattern of deficiencies within a system may demon ...

YES.
The objective of FDA regulatory programs is to assure compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Specific enforcement activities include actions to correct and prevent violations, remove violative products or goods from the market, and punish offenders. The type of enforcement activity FDA uses will depend on the nature of the violation. The range of enforcement activities include issuing a letter notifying the individual or firm of a violation and requesting correction, to criminal prosecution of the individual or firm. Adulteration or misbranding is usually the result of an individual failing to take steps to assure compliance with the law. Such an individual may be liable for a violation of the Act and, if found guilty, be subject to the penalties specified by the law.


Warning Letters - are sent to the individuals or firms, advising them of specific noted violations.; These letters request a written response as to the steps which will be taken to correct the violation. These letters constitute one form of warning that can be issued under current Agency policy.


Seizure - An action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the Act. The purpose of such an action is to remove specific violative goods from commerce.

Injunction - An order by a court that requires an individual or corporation to do or refrain from doing a specific act. FDA may seek injunctions against individuals and/or corporations to prevent them from violating or causing violations of the Act.


Criminal prosecution - may be recommended in appropriate cases for violation of Section 301 of the Act.; Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.

beiwei5du

kslam 发表于 2017-8-24 12:16
YES.
The objective of FDA regulatory programs is to assure compliance with the Federal Food, Drug ...

这个不应该画等号的!
Evidence to support significant and/or a trend of deficiencies within a system covered could demonstrate the failure of a system and should result in consideration of the issuance of a Warning Letter or other regulatory action by the District. When deciding the type of action to recommend, the initial decision should be based on the seriousness and/or the frequency of the problem. Examples include the following:
选自：https://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125404.pdf

kslam

beiwei5du 发表于 2017-8-24 12:22
这个不应该画等号的!
Evidence to support significant and/or a trend of deficiencies within a sys ...

I humbly ask - What is your "two-cent worth of opinion"?