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ISPE - Aseptic Filling Line - NJChapterPaulMelamudPres
ISPE - Aseptic Filling Line - NJChapterPaulMelamudPres
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The collection and evaluation of data, from
the process design stage throughout
production,
d ti
which
hi h establishes
t bli h scientific
i tifi
evidence that a process is capable of
consistently delivering quality products
products
Purpose:
Purpose: to demonstrate SISPQ
SISPQ
Strength, Identity, Safety, Purity, Quality
Includes product attributes & data integrity
2
Equipment,
q p
,p
processes,, and p
products
that are in scope
Critical Quality
y Attributes ((CQA))
imparted to the product and/or data at
each station
Critical Process Parameters (CPP)
that allow control of the CQA
Critical In-Process Controls (CIPC)
monitor CQA or CPP at each station
Sterilization:
Ste
at o sta
standard
da d reqs:
eq s
(5min @ 320C, laminar flow,
discharge 25C)
Contact Information
Paul A. Melamud
Validation Manager
paul.melamud@qpharmacorp.com
973-656-0248, x2008
Scott Collins
Senior Validation Manager
scott.collins@qpharmacorp.com
973-656-0248, x2110
QPharma Inc.
22 South Street
Morristown, NJ 07960
www.qpharmacorp.com