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Todayʼs Topics
1. A Quick Recap of Our Previous Session
2. PICS Part I - Chapter 3 Premises and Equipment
3. PICS Part I - Chapter 4 Documentation
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2. Chapter 3: Premises and Equipment
Premises and equipment must be located
, designed
, constructed
, adapted
and maintained
to suit the operations to be carried out.
The layout
and design
must aim to minimize the risk of errors and permit effective cleaning and maintenance in
order to avoid cross-contamination, build up of dustdirt and any adverse effect on the quality of products.
Itʼs about design + engineering
Hi gh
l e
gu la
te d Pharmaceutical
industry provides unique
challenges
No o
e t
a s
e PICS does not
specify criteria or numerical for
premises and equipment
W ith
h a
d
so ft
te hs
Your ingenuity will be
everything
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PRINCIPLE
Premises and equipment must be located, designed, constructed, adapted and
maintained to suit the operations to be carried out. Their layout and design must
aim to minimize the risk of errors
and permit effective cleaning
and maintenance in order to
avoid cross-contamination , build up of
dust or dirt and, in general,
any adverse effect on the quality of products.
Premises should be carefully maintained, ensuring that repair and maintenance
operations do not present any hazard to the quality of products. They should be
cleaned and, where applicable, disinfected according to detailed written
procedures. .
2. Chapter 3: Premises and Equipment
General
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2. Chapter 3: Premises and Equipment
A typical flowchart in facility project case:
Feasi ilit
Co eptual de elop e t
P oje t pla i g
Basi desig + DQ
Detailed desig +
Spe ifi atio Supplie
sele tio Co st u tio
+ i stallatio
IQOPPQ
P odu tio + ai te a e
Expertise involved in all phases from design concept to production …
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Risk Co t ol De easi g Risk
Risk A epta e Fish Bo e, FMEA et .
UR
６ ＩＳＰ
Ｉ ｉａ
PUR P odu t Qualit
CQA CPP,GMP GUR
P odu t Capa it Et .
Co eptual Desig Risk Assess e t
Spe if Risk Risk A al sis
SIA Risk Assess.
Desig Co ept Desig data et .
URS PUR
P odu t Qualit CQA CPP,GMP
GUR P odu t Capa it
Et . C iti al Aspe ts
Fa ilit S ste Spe ifi atio
Basi Desig
Detail Desig
DQ VMP
Co st u tio Co
issio i g IQ,OQ
PQPPQ Risk Re ie
Mo ito i g Self I spe tio
Co e ial
P odu tio
Mai te a e P og a
w w
R M
T a ta ilit Mat i
Qualifi atio
Co issio i g
2. Chapter 3: Premises and Equipment
