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Quality Agreements
CMC Post-Approval Changes
Comparability Protocol
You may still have pharma company clients wary of the change even when you notify them of the change. The facility compliance guidelines support making the compliancy change without going through the PAS process. This is where the third guidance comes into play, and it is the updated guidance on comparability protocols for human drugs and biologics (3). A comparability protocol has the potential to decrease the filing category.
Engineering Data
For instance, items that would normally be handled as a PAS have the potential to be considered as a changes-being-effected-in-30-days supplement. By employing the use of a comparability protocol within production scheduling, you are making sure your facility compliance client understands the change you will be implementing. The production engineering data you will be collecting and reviewing to assess that the upgrade was successful can demonstrate changes did not affect product quality.
The comparability protocol is a pharmaceutical science compromise when you have clients insisting on a PAS and others who are comfortable with the annual reportable strategy. It allows you to file the protocol as a PAS and build the inventory needed in preparation for the anticipated shutdown period.
Contract Manufacturing
There are no right or wrong answers when recommending filing strategies to a client. Regardless of what the contract manufacturing organization says, the client can always choose an alternative design for manufacturing. The best way to convince a client of a filing strategy is to make sure you have a robust quality agreement in place that gives you the responsibility for maintaining your facility.
Become familiar with the regulations and use them to justify your recommendation. Finally, use a comparability protocol for proving like-to-like equivalency, and present the recommendation to the client in a documented manner. These facility compliance steps should help you implement a facility upgrade in a timely manner while reducing your downtime to make the improvement.
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