Module 5 Presentations

05/07/2024

IMPD Pitfalls

Section(s)

Failing(s)

• For biologicals, changes to manufacturing process are not supported by comparative data • Chemically defined substances not clearly established. • Spectra required but absent. • Difference between “analytical procedure”, theway the analysis is performed, and “analytical method”, the principles of the method used, should be considered • Tabulated summaries of results required for phase II, III but absent. • Full validation reports provided instead of the required summaries. • Representative batch analysis data missing. • Batch analysis only included for one manufacturing site when multiple sites proposed. • Representative data for some batch sizes but not all included without justification.

S.2.6 Manufacturing Process Development S.3.1 Elucidation of Structure S.4.2, S.4.3, P.4.2, P.4.5, P.5.2, P.5.3 Analytical Procedure/ Validation S.4.3 and S.5.3 Method Validation

S.4.4, P.5.4 Batch Analysis

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IMPD Pitfalls

Section(s)

Failing(s)

S.4.5 and P.5.6 Justification of Specifications

• Justifications not provided for specification limits and for the proposed control, or not, of specific characteristics

S.7 Stability

• Data on the stability of the DS is not included or not tabulated. • No shelf-life period has been unambiguously proposed. • For biotech, shelf-life, not retest applies and no retesting is acceptable. • The protocol for shelf-life extension is insufficient. An acceptable plan requires: - Specification for product being tested - Criteria for extrapolation - Analysis of trends - Proposed extension criteria and commitment • Data on the stability of DP is not included or not tabulated. • In-use stability not considered.

P.8 Stability

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