Module 9 2024

03/09/2024

Specific Considerations for Vaccines

The Organisation for Professionals in Regulatory Affairs

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What are the requirements?

⚫ Licensed vaccines must be*:

⚫ Safe ….well tolerated…: “relatively free from harmful effect … when prudently administered, taking into account the character of the product in relation to the condition of the recipient at the time.”

⚫ Pure: “relatively free from extraneous matter in the finished product,…”

⚫ Potent: “specific ability of the product … to effect a given result.”

⚫ Manufactured consistently according to current Good Manufacturing Practices

⚫ … and ideally, registered as quickly as possible in order to be made available to people who need them

* Regulatory Considerations for the Manufacture of Investigational Vaccines for Clinical Trials Jon R. Daugherty “Office of Vaccines Research and Review NIAID Regulatory Course 30th October 2007

The Organisation for Professionals in Regulatory Affairs

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