RISK-BASED CHANGE CONTROL - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 375

TABLE 13.6 Risk Assessment for Changing Bottle Manufacturer
Process Step,
Change Control,
Deviation, Failure

Current Accept

Event, etc. F SEV Causes OCC Controls DET RPR Risk? Actions

Change supplier of
product vials

Bottles are not
adequately
sterilized

H Bottles have different

dimensions and/or
different materials of
construction (MOC)

M Vendor has confirmed
will meet same
dimensional specs and
MOC; QA acceptance
sampling

L M N Increase IQA inspections and

perform a vendor audit

Change supplier of
product vials

Bottles not
adequately
sterilized

H Bottles have higher

incoming bioburden;
inadequate GMP,
manufacturing
controls, etc.

M Vendor states bottles
will meet current
bioburden specs;
incoming IQA testing

H H N Perform vendor GMP audit

before purchase; perform
increased IQA bioburden
testing, perform media fill
for first batch; perform
cleaning validation studies

Change supplier of
product vials

Bottles not
adequately
sterilized;
residual film or
presence of
particulates

H Bottles are

contaminated;
different mold release
agent used

H Vendor states release

agent causes no
problem with other
pharma customers;
IQA testing

H H N Perform cleaning validation

studies; perform media fill

Change supplier of
product vials

Sterility failure H Bottles broken/cracked

because of different
packaging
configuration or
package size

M Vendor states will
provide vials
adequately packaged
to prevent breakage;
IQA testing; final
product testing

M H H Place packaging requirements

into purchasing spec;
perform media fill, increase
IQA testing for first three
lots