Tag
#gmp
2 topics across all disciplines.
Cleanrooms — grades, particle counts and the air that holds them
What an ISO 14644 class actually counts, how EU GMP grades A to D map onto it, why a cleanroom is defined at rest and in operation, and why the pressure cascade matters more than the filters.
Qualification and validation — DQ, IQ, OQ, PQ and the record that proves it
What each qualification stage actually tests, why the user requirement specification governs everything that follows, where the three-batch convention comes from, and why a deviation handled properly is better evidence than a protocol with no deviations at all.