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Risks Assessment And Countermeasures On The New Workshop Project Of Powder For Injection

Posted on:2016-07-24Degree:MasterType:Thesis
Country:ChinaCandidate:B M HuangFull Text:PDF
GTID:2309330482471975Subject:Project management
Abstract/Summary:PDF Full Text Request
Risk management principles are effectively utilized in many areas of business and government including occupational safety, finance, insurance, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. In addition, the importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system. All medicinal products are associated with some risks. At the time of authorisation, information on the safety of a medicinal product is relatively limited, not all actual or potential risks will have been identified. It’s important to ensure the risks are actively managed in order, as far as possible, to minimize SARs in users, and to ensure that the Benefits of a drug outweigh the Risks of therapy. This text takes an example of Fukang new workshop project of powder for injection.
Keywords/Search Tags:risk assessment, powder for injection, design qualification
PDF Full Text Request
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