Biomedical Engineering Reference
In-Depth Information
4.1.4 Testing Plan
The overall risk management plan, including the risk assessment (criticality determina-
tion and safety assessment) and the testing plan, is shown in Fig. 4.1. This testing plan
reflects criticality determination, safety assessment, and regulatory requirements for
product attributes. The attribute classification (high, medium, or low risk to product
quality) serves as a rationale for the product testing plan (routine monitoring, character-
ization testing, no testing), specifications, and process controls that ensure minimal risk
to product quality. The selection of tests appropriate for an attribute is based on the prior
product knowledge and the overall control strategy. Each product quality attribute may
be assessed by multiple tests. For example, monoclonal antibody fragments can be
detected by SDS-PAGE, analytical ultracentrifugation, high-performance size-exclusion
chromatography, and reversed-phase HPLC [4].
The specifications for a product can be established by using a combination of
approaches, consistent with the guidance in ICH Q6B (Fig. 4.4). Wherever appropriate,
certain attribute specifications are based on existing regulatory guidance. For other
attributes, limits are established by considering both the prior product knowledge from
Elucidation of
structure
Validation of
anlytical
procedures
Impurities
Process
evaluation
Justification of specifications
Stability
Description of
manufacturing
process and in-
process control
Regulatory
requirements
Specifications
Batch analysis
Figure
4.4.
Information sources that contribute to specifications.
