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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
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Choose proper clean class for each process
！
Example of Aseptic process ISPE Baseline Guide Vol.3, Jan 1999 G
Grade Grade
Grade Min.
Intervention FillingＧProcess
CleanＧBench NoＧ
Intervention Critical portionＧfor sterile
Grade C Grade
B Grade
Grade D Grade
内 Critical area
Grade ＩＳＯ ５
FillingＧroom Grade
ＩＳＯ Sterile
Garment Grade
ＩＳＯ Grade
ＩＳＯ Clean
Garment FormulationＧ etc.
WashingＧToolsＧetc. Grade
＊ CNC Grade
Unclassified Grade
External Uniform+α
Uniform Uniform
Private 2ryＧPackagingＧroom
OrdinaryＧArea OfficeＧ・Warehouse
Canteen・Ｑ Machine room,ＧOut side.
Co t olled ot lassified
2. Chapter 3: Premises and Equipment
Clean Garment
OSD
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2. Chapter 3: Premises and Equipment
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2. Chapter 3: Premises and Equipment
Whether a new or existing facility, clarify the concept first. Be certain it can be explained by you.
What do you want the premises to do?
U le
a o
ep t
Mountains of books
Q RM
ap p
oa h
Scientific evidences Good qualification practice
Knowledge management
Use of quality risk management QRM approach Implementation of DQIQOQPQ
Make all records comprehensible to any personnel. Turn your mountains of books into the best practice
Letʼs discuss it in more detail later on the next Chapter: Documentation
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2. Chapter 3: Premises and Equipment
Situated in a suitable environment Carefully maintained ensuring the cleanliness
Appropriate lighting, temperature, humidity and ventilation Designed as to afford protection against the entry of insects
Steps taken to prevent the entry of unauthorized people General requirements for premises
Lo atio
HVAC ME
E t o t ol A ti‐i se ts
a ti‐s ui el Mai te a e
La
Utilit a d
P odu tio a ea
So ial I te a tio
Spa e
Offi e
P odu tio a ea
Wa e‐ house
Site Pla
N
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Lighting, temperature, humidity and ventilation should be appropriate and such
that they do not adversely affect
, directly or indirectly, either the medicinal
products during their manufacture and storage, or the accurate functioning of
equipment.
Premises should be designed and equipped so as to afford maximum protection
against the entry of insects or other animals. .
2. Chapter 3: Premises and Equipment
