Analytical Method & Technology Transfer Ispe Guide

ISPE Good Practices Guide: Analytical Methods/Technology Transfer Prepared and presented by: Gilberto González-Rivera IPR Pharmaceuticals, Inc.

Technology Transfer Guide ,[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],Technology Transfer Guide

Objective ,[object Object],[object Object]

Definitions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Definitions ,[object Object],[object Object],[object Object]

Planning and Success Criteria ,[object Object],[object Object]

Note to the Reader ,[object Object]

Scope ,[object Object],[object Object]

Responsibilities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Methods to be Transferred ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Pre-transfer Activities ,[object Object],[object Object],[object Object]

Transfer Protocol ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Transfer Protocol ,[object Object],[object Object],[object Object],[object Object]

Transfer Protocol ,[object Object],[object Object]

Transfer Report ,[object Object],[object Object]

Experimental Design / Acceptance Criteria

Assay ,[object Object],[object Object],[object Object],[object Object]

Acceptance Criteria ,[object Object],[object Object],[object Object]

Content Uniformity ,[object Object],[object Object],[object Object],[object Object]

Acceptance Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object]

Impurities / Degradant ,[object Object],[object Object],[object Object]

Impurities / Degradant ,[object Object],[object Object]

Acceptance Criteria ,[object Object],[object Object],[object Object],[object Object]

Dissolution ,[object Object],[object Object],[object Object],[object Object],[object Object]

Identification ,[object Object],[object Object],[object Object],[object Object]

Automated Methods ,[object Object],[object Object]

Automated Methods ,[object Object],[object Object],[object Object],[object Object],[object Object]

Cleaning Verification ,[object Object],[object Object]

Microbiological Testing ,[object Object],[object Object],[object Object],[object Object],[object Object]

Microbiological Testing ,[object Object],[object Object]

Acceptance criteria ,[object Object]

Dose Delivery (include, but not limited to): ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Particle Size ,[object Object],[object Object],[object Object]

Acceptance Criteria ,[object Object],[object Object]

Particle Size Analyzers: Instrumental ,[object Object],[object Object]

Alternate Approaches ,[object Object],[object Object],[object Object],[object Object]

Alternate Approaches ,[object Object],[object Object]

Analytical Method & Technology Transfer Ispe Guide

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