Solid dosage form area/purified water qualification

GOOD VALIDATION PRACTICE (cGVP)
1

Dear sir,

Please give referance guide and suggestion for how many day non viable or viable particle count monitoring in new solid dosage form facilty at initial stage HVAC system qualification.

Please give name or link for Same this facility for purified water qualification quideline

Regards
Mahesh

2

Look into USP purified water requirements for TOC (usually NMT 500ppb), conductivity (NMT 1.3uS/cm), microbial limits, filter pressures etc. The qualification of purified water system depends on several factors: design of the equipment, type (RO, UV etc…), capacity, flow pattern etc… Hope this helps.