VALIDASI

Stablishing documented evidence which provides

a high degree of assurance that a specic process
will consistently produce a product meeting its
pre-determined specications and quality
attributes
Action of proving, in accordance with the
principles of Good Manufacturing Practice, that
any procedure, process, equipment, material,
activity or system actually leads to the expected
results (see also qualication).
Good Pharmaceutical Manufacturing Practice,2004
 QUALITY
A systematic and independent examination to
determine whether quality activities and
related results comply with planned
arrangements, and whether these
arrangements are implemented effectively
and are suitable to achieve objectives (ISO
8402: 1986, Quality Vocabulary)
A systematic and independent examination of
the Quality System or of its parts (EOQ)