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Call for Volunteers: New PDA Standard on Biologics Validation/QC

PDA is seeking volunteer participants to assist in developing, writing, and fine tuning the following proposed new American National Standard (ANS) standard:

Analytical Method Validation and other Lifecycle Control Steps for Quality Control Testing of Biologics

This standard will build from PDA Technical Reports No. 57 and No. 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) and 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

Stephan O. Krause, PhD, Quality Director and Head of Product Quality Leaders at AstraZeneca Biologics, is the lead.

Biologics sponsors and manufacturers, those individuals involved in Quality Assurance, Operations and Manufacturing, Validation, Consultants, Regulatory, International Health Authority Reviewers and Inspectors are being sought.

Nominations/Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard. Applicants should apply by contacting the PDA Standards Manager at [email protected]. The deadline to submit notification of interest in serving on the consensus body is November 23, 2020.

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