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QMS, General/Global, specific for facility - Coggle Diagram
QMS
Supject
QC
release tests
IPCs
performed internally
performed by 3rd party
final product stability
LN
refrigerated products
-80oC
raw materials stability
intermediate stability
Raw materials
specification
Equipment
URS
Documents control policy
Consumables
Specification
safety
personnel training and qualification policy
BSC
bioisolator
aseptic manufacturing
Logistics
to clinical sites
to manufacturing facility
cleaning
Policy
Procedure
deviations
Policy
Procedure
Form
CAPAs
procedure
Form
EM policy
procedure
subcontractors policy
procedure
Gowning
procedure
batch numbering
qualification and validation policy
VMP
process validation
media fill
PPQ validation** (process performance)
equipment qualification
analytical method validation policy
computerized system validation
calibration and maintenance policy
utilities management
aseptic techniques
grade D
grade B and A
falcification /counter feit medicine policy
Quality Policy
complaints (in and out)
contamination policy
Change Control policy
annual review policy
Project management policy
management review policy
data integrity policy
OOS/OOT policy
risk policy
purchasing policy
site master file
Tech Transfer policy
Visual inspection
regulatory compliance
ATMP
phase I
phase II
phase III
commercials
R&D
Biologics
phase I
phase II
phase III
commercials
R&D
viral vector manufacturing
intermediate structure
tissue establishment
depend on region
medical device
pyramid structure
corporate policy
local procedures
manufacturing technology (isolator/BSC)
SOP
forms
batch record
General/Global
specific for facility