BIOPHARMACEUTICAL MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 353

Supplier Input Process Output Customer

Cell culture Cell nutritional

needs

Down stream
processing

Master cell bank

Working cell bank

Banks

Supplier quality Audit data Audit report Quality assurance

Regulatory affairs Review

international
requirements for
animal derived
products

Standards
reviewed

Supplier quality

Quality assurance
Health authorities

Quality assurance Supplier quality

data review

Certification of
acceptability and
compliance with
applicable
regulations

Cell culture

Health authorities

QXR serum supply
company

Data on FBS
collection and
processing
activities

FBS Cell culture

Collect datafrom
QXR serum supply
company

Certify vendor as
acceptable

Analyze data

Figure A.1 SIPOC analysis: FBS utilization.

input, process, output, customer. It is a standard Six Sigma graphic that may be
used to gather fundamental information into an organized graphic that will allow
the team to focus the assessment. The SIPOC assessment shown in Figure A.1
indicates that the scope of this issue extends from the vendor, QXR Serum Supply
Company, through to certifying the vendor as acceptable.
Team selection : Teams that include subject matter experts who have knowledge
of the issue and can thoroughly identify and assess the associated risks should
be chosen. For example, an assessment of FBS might include representatives
with expertise in cell culture, formulation development, supplier quality, quality
assurance, regulatory affairs, etc.
Product analysis : At this stage, the team should develop a high level under-
standing of the product and its usage. The serum itself will be used as a nutritional
supplement in the production of cell banks for the XYZ product line. In this con-
text, the team should identify the critical quality attributes of the product. For
FBS, a critical quality attribute would be its ability to support the growth of cells.

A.3 Risk Assessment

Risk identification : The hazard analysis in the following, Table A.1, shows
that five principle hazards were identified: contamination (microbiological),