[Steve Jacobs]

Reply To: Post-Packaging ID Testing

I liked the answer of using a risk assessment on whether or not to do ID testing. My question is if you and your QA group audited and qualified your vendor, why would you need to do ID testing if you’re having QA review the Executed Packaging Batch Records.
If you are concerned that your vendor may screw up your packaging, why are you with them? PPID is usually done by companies that don’t really get the clinical supply chain, have experienced multiple quality issues, or are very risk averse.
The majority of companies don’t do it as it takes extra time and the reality is that testing is never the only way to make sure quality is built into packaging and labeling. That’s why you audit your vendor and take the time to work with them to understand your needs and quality expectations.
If your packaging vendor has built their quality systems by using the concept of Quality by Design, then you shouldn’t need to do PPID.
Happy to talk this through further if you want to connect.