Glossary

Qualified Person (QP)

Also: QP

The individual who certifies that each batch of a medicinal product has been manufactured and tested in line with GMP and the marketing authorisation before it is released.

In the EU a QP must certify each imported batch from a third country before it can be released to the market.

The QP role is central to import: without QP certification, a third-country batch cannot be released.

See it live in 25 minutes.

Eight guided flows: compliance review, DPS screening, Part 11 e-signature, custody chain, breach prediction, GDPR erasure and the validation report. Then a 90-day pilot on your own programme, fully creditable.