ASEPTIC PROCESSING: TWO - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 249

TABLE 10.5 Typical Applications of Risk Assessment, Applied Throughout the Product or Process Lifecycle
Stage in Lifecycle Event or Trigger Objective Purpose Data Available Risk Assessment Tool

Design Initiation of design,

part of design
management

Prospective
analysis of
designs

Evolve the product or
process to design out
opportunities for harm

Minimal, qualitative,
semi-quantitative

Fault tree analysis
FMEA
FMECA

Development Approved design Establish control

strategy

Define critical quality
attributes

Qualitative Fault tree analysis

FMEA
FMECA

Optimization of
monitoring

Choose monitoring
locations, frequency

Qualitative and
quantitative

FMEA
HACCP
FMECA
Akers & Agalloco Method [23]
Whyte & Eaton Method [24]
LR method [32]

Validation Approved validation

plan

Optimized
validation

Choice of worst-case
conditions

Qualitative and
quantitative

FMEA
FMECA
Akers & Agalloco Method [23]
Whyte & Eaton Method [24]
LR method [32]

Routine
Operation

Change control Prospectively

evaluate product
quality risks

Ensure patient safety Qualitative and

quantitative

FMEA
FMECA
HACCP
Akers & Agalloco Method [23]
Whyte & Eaton Method [24]
Quantitative risk assessment [19]

Excursion or
exception

Product
disposition

Evaluate patient safety
risk

Qualitative and
quantitative

FMEA
HACCP
Akers & Agalloco Method [23]
Whyte & Eaton Method [24]
Quantitative risk assessment [19]