Process Characterisation | PharmaBharat Tools

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Process Characterisation | PharmaBharat Tools

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Acceptance Criteria Analytical Method Active Pharmaceutical Ingredient(API)Assay Bacterial Endotoxins Bracketing Certificate of Analysis(CoA)Child-Resistant Packaging Comparability Container Closure Integrity(CCI)Container Closure System(CCS)Content Uniformity Control Strategy Critical Process Parameter(CPP)Critical Quality Attribute(CQA)Critical Material Attribute(CMA)Design Space Dissolution Drug Product(DP)Drug Substance(DS)Elemental Impurity Excipient Extractables and Leachables(E&L)Forced Degradation Hold Time Study Impurity In-Process Control(IPC)In-Use Stability Matrixing Analytical Method Transfer Method Validation Nitrosamine Impurity Particulate Matter Photostability Process Analytical Technology(PAT)Process Characterisation Quality by Design(QbD)Raw Material Reference Standard Release Specification Residual Solvent Retest Period Scale-Up Shelf Life Shelf-Life Specification Specification Stability Chamber Stability-Indicating Method Stability Protocol Stability Study Stability Trending Starting Material Tamper-Evident Packaging Technology Transfer

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RA CMCProcess Characterisation

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Process Analytical Technology (PAT)Quality by Design (QbD)

Process Characterisation

CMC

Definition

Studies to understand process parameters and their impact on quality attributes, supporting control strategy and validation justification.

Regulatory source

ICH Q8(R2), ICH Q11