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Which manufacturing changes have the least potential to adversely affect product quality? That’s the question the FDA has attempted to answer in a new draft guidance released this week. FDA released the draft guidance in response to an increase in the number of postapproval manufacturing supplements it has received in recent years. Specifically, industry has sought FDA recommendations on the types of changes that can be documented in an annual report, rather than in a supplement. The changes FDA is recommending be included in such an annual report are focused on five areas: Components and composition; manufacturing sites; manufacturing process, batch size and equipment; specifications and container closure systems. Many of the changes included in the appendix and to be documented in an annual report are either slight modifications or those that would have no impact on the current risks of the manufacturing. For instance, ...NEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...