Thread by @SQAHeadquarters

Closing Plenary underway #sqa2022

A gathering of regulators.

#sqa2022

A: In France they are inspected in the same way. No difference. #SQA2022

FDA prepares for inspections in the same way. A little different in the execution. #sqa2022

Next Question #sqa2022

Not required for FDA, but they would like to know about it. #sqa2022

Sharing information is a good practice. #sqa2022

Next Question. #sqa2022

Guidance being developed ... there has been outreach. BIMO Ch 5.10 - FDA can request read-only access. It is a goal to like see some sort of direct access similar to EMA, but FDA is not there yet. Need to harmonize internally first. #sqa2022

Question about success metrics #sqa2022

FDA: Success metrics are internal to BIMO. The goal is to get on the same page and move forward. New internal compliance function is relevant. The goal is consistency between divisions. #sqa2022

Next question #sqa2022

When we inspect sponsor, it is application driven and will trigger an inspection - not based on studies. We would review the compliance program at minimum. Unrelated to GLP studies. #sqa2022

Next question #sqa2022

Yes for FDA, the process is the same.

In the UK, they will perform system and study-specific inspections.

FDA -- What may be different is the logistical challenges, translation issue. But inspection approach is the same as what they do domestically. #sqa2022

Focus on PV question #sqa2022

The compliance programs won't be updated. See the IOM manual - overall manual for how FDA inspections are conducted. #sqa2022

An MHRA question #sqa2022

MHRA needs to get more information. #sqa2022

GLP/GMP question

FDA: We need to access data to verify information. A certificate of analysis isn't enough bc it doesn't give you the data behind it. #sqa2022

#sqa2022

FDA encourages this approach - great process validation guidance document exists. It from design verification to 2nd stage (Process performance Qualification). It must be continuously verified once it is in the market - the stage 3 concept. #sqa2022

Thank you for the regulatory panel #sqa2022

Jackie thanks everyone for attending both in person and virtually. #sqa2022

Jackie's #sqa2023 Co-Chair is Joseph Whittemore. See you next year in D.C. for the 39th Annual Meeting and Quality College in March.

#sqa2022.

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