3582428299
W
SCOP
GA ON (BK), PUNĘ-041
ACADEMIC GUIDE Mi s . M.A.NAGRAS Assistaiit Profcssor
INDUS TRIA L GUIDE
I kii. na(;esh patiu
Srjnanagfi' QA (lept. Eincure pluu inaceuticals Hinjewadi. Punę.
PRESENTED BY Kaustubh V. Kandliarkar M.Pliarm (IV* SEMESTER)
DEPARTMENT OF QUALITY ASSURANCE
TECHNIQUES
SINHGAD COLLEGE OF PHARMACY YADGAON (BK), PUNE-041
*
I i
IINHCAD TKCHNlCAL EDUCATION 60CIETY
Definition of process yalidation:
As per FDA - process yalidation is defined as establishing documented evidence \vliich provides a high degi ee of assurance tliat a specific process, metliod will consistently produce a product meeting Predetennined specifications and ąuality attributes.
According to new 21CFR guideline -
Process Validation is defined as the collection and evaluation of data, from tlie process design stage tlirougliout production, wliich establishes scientific evidence tliat a process is capable of consistently delivering quality
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