A standard, based off PDA Technical Report 57 and 57-2, used for completing analytical lifecycle steps to facilitate successful product development and regulatory submissions. This benefits stakeholders, industry, and agencies.
Standardizing analytical platform technology (APT) method qualification/validation/transfer methodology will provide risk-based studies and greatly reduce manufacturer’s cost, time, and resources. This should also reduce agency market authorization review time (for analytical methods).
This document will provide a method-type specific study design, statistical tools, and the setting of acceptance criteria for the following analytical lifecycle steps:
- Analytical Method Qualification (AMQ)
- Analytical Method Validation (AMV)
- Analytical Method Transfer (AMT)
- Analytical Method Comparability (AMC) for replacing approved methods
- AMQ, AMV, AMT, for APT methods
- Technical Writing/Editing
- Packaging Science, Container Closure
- Process Engineering
- Quality & Compliance
- Regulatory Affairs
- Auditing/Inspection Response
- ATMP/Gene and Cell Therapy