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site master file

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SOP
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SOP
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SOP


air lock

/ / penicillins,
cephalosporins, , sex hormone cytotoxic drug
(campaign)

(campaign)


Filter G4 + F9 + HEPA AHU
potent drugs, HEPA H13
environmental monitoring

HVAC

(primary packaging)

(secondary packaging)
(partition)

//

log book



log
book


/
/ lot number




LAF microbial limit test
Sterility test

hood
safety shower eye wash

operating, cleaning, maintenance


and/or calibration

(preventive
maintenance)

cleaning

validation -

validate


sanitization
sanitizing method
alert limit, action limit (trend
analysis)
alert limit

/ action limit

SOP

SOP




(specification)




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SOP

(log book)


SOP


SOP

SOP

approved vendor list


/



SOP

area clearance

approved vendor list


/





aluminium foil sticker

line clearance

SOP

SOP tailing

SOP

SOP

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/
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(Trend Analysis)

SOP


SOP


volumetric solutions
volumetric solutions
(positive/negative control)


SOP

/



.

SOP


SOP flow
chart

SOP

SOP

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2

(VMP)

(HVAC)

HVAC qualification
(Environmental Monitoring)




stainless steel
316
316 L passivation
passivation

sanitization

process validation

(maximum hold time)




/
/
HVAC
EN ISO
14644



(in operation)
A/B aseptic preparation
B (in operation)
clean up period

/
/

(alert and action


limits)
(validation)

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-
(clean-in-place)
(sterile-in-place)
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A C


C
D


A B

C
A
B

A B


A B

B


A B
training

non-sterile

epoxy, poly-urethane PVC sheet
epoxy , epoxy ,
, fiberglass reinforced plastic (FRT)


A/B

A/B


airflow pattern A ( ISO 14644)

A B


/

aseptic process

terminal sterilization

A
B

Formalin

PI 007 PIC/S Recommendation on the


validation of aseptic processes

sampling
plan,
softener, resin, carbon, RO, DI, EDI
purified water water for injection
sanitization
sanitizing method
alert limit, action limit (trend
analysis)
alert limit
/ action limit

water for injection

holding time


holding time

bioburden
bioburden
( terminal sterilization overkill cycle)
rapid micro-methods

aseptic process

laminar

. m

overkill cycle
development (cycle design)



data logger, multi-recorder
cold spot


( aseptic)

(
aseptic)

( terminal
sterilization)

(
terminal sterilization)

purified water

(HEPA filter)

(radiationsensitive colour disk)

leak test
A

(double check)