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BSR/PDA Standard 07-202x, Analytical Method Validation and other Lifecycle Control Steps for Quality Control Testing of Biologics (New Standard)

Type:
  • Standards Development
Application Deadline: 23 Nov, 2020
Location:
  • Virtual
Openings: 20

Description

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

Skills

  • Technical Writing/Editing
  • Biotech
  • Packaging Science, Container Closure
  • Process Engineering
  • Quality & Compliance
  • Regulatory Affairs
  • Auditing/Inspection Response
  • ATMP/Gene and Cell Therapy

Requirements