Pharma operates under GMP, FDA 21 CFR Part 11 and EU GMP Annex 11. ISO Class 5-8 cleanrooms, sterilizable equipment and CSV. Bosch Pharmatec, Optima, Glatt and Syntegon lead Germany.
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Pharma
Pharma operates under GMP, FDA 21 CFR Part 11 and EU GMP Annex 11. ISO Class 5–8 cleanrooms, sterilizable equipment a...
Pharma operates under GMP, FDA 21 CFR Part 11 and EU GMP Annex 11. ISO Class 5–8 cleanrooms, sterilizable equipment and computer-system validation are standard.
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FAQ
Q What is CSV?
A
Computer System Validation — pharma IT systems classified per GAMP 5, validated (IQ/OQ/PQ); electronic data integrity ensured.
Q GMP A/B/C/D?
A
Grade A is strictest (sterile fill core, unidirectional 0.45 m/s); B as A background; C/D auxiliary zones. Design and validation mandatory.
Q Chinese pharma export to Germany?
A
GMP on-site audit (EMA/BfArM); EDQM CEP / DMF registration; batch consistency and impurity GLP data.