Glossary

Good Manufacturing Practice (GMP)

Also: GMP

The standard governing the manufacture of medicinal products so they are consistently produced and controlled to the quality appropriate for their intended use.

GMP sits upstream of distribution. Batch certification under GMP, by a Qualified Person in the EU, is a precondition for releasing product to market.

GMP and GDP together cover the product from manufacture through distribution.

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.