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A critical GMP requirement for drug manufacturers is to validate analytical test methods to ensure that they are suitable for their intended uses. There are published guidelines available that the industry can follow for validation but there are none for qualification, which is a key step in the validation process.
A critical GMP requirement for drug manufacturers is to validate analytical test methods to ensure that they are suitable for their intended uses. There are published guidelines available that the industry can follow for validation but there are none for qualification, which is a key step in the validation process. "Validation as a concept is well-understood in the industry but there are some gray areas that exist in qualification," said Melissa Smith, principal consultant at MJQuality Solutions, LLC. It is these "gray areas" that the Parenteral Drug Association's (PDA) Analytical Method Development (AMD) Task Force is aiming to address in a new technical report.
Smith, who co-chairs the AMD Task Force with Earl Zablackis (co-chair), director of method validation and transfer at sanofi pasteur, presented the first draft of the technical report, Analytical Method Development and Qualification for Biopharmaceutical Products, at the PDA Annual Meeting held in Orlando, FL, from March 15–19, 2010.
A Risk-Based Approach
According to Smith, biopharmaceutical organizations currently approach qualification in different ways, so the AMD team first defined a qualified method. The AMD Task Force is working on three different qualification models using process maps to describe how different organizations approach qualification.
Based on the process maps, the AMD team is structuring the models around five major content areas, which include method attributes and design, method development, qualification, method transfer, and validation pre-requisites.
These models represent current best practices in qualification and include elements of Quality by Design and risk assessment. "The models will evaluate the impact of risk on [analytical method] design, development, and qualification," Smith added.
Once complete, the technical report will undergo a standard review process at PDA, which will include a review by regulatory agency representatives. After the approval process is complete, the report will then be available to all members. "This will be a global document that the industry can use as a practical guidance for development and qualification," concluded Smith.
Two Harmonized PDA Reports
The AMD Task Force report will align with applicable principles of GMP requirements, ICH, FDA, and EMEA guidance documents, USP/EP, and prior PDA technical reports and FDA whitepapers.
The AMD report also will dovetail with another pending PDA task force report on analytical method validation (AMV). That report developed by the AMV Task Force, chaired by Stephan Krause, principal scientist at MedImmune, Inc., where he is responsible for analytical method qualification, validation, and transfer, and coordinating global specifications coordinator. The AMV report now is under final review by PDA and several regulatory agencies and covers method validation, transfer, and comparability, and all practical and post-validation steps. It explains how to apply quality risk management to analytical methods and AMV studies, and includes several case studies.
"The AMV report contains practical suggestions and case studies for topics such as method transfers, replacing methods, and how to best deal with failures," said Krause, who has published many articles and books on these topics. "The intent of the strategies and case studies presented in our report was to deal with all management and regulatory aspects within the modern quality framework of ICH Q8–10," he added.
The AMD and AMV teams are now working together to produce two integrated technical reports, with the AMD report focusing more on development and qualification, while the AMV report covers validation. "Although the two documents will be published separately, they are harmonized," said Smith. "The harmonized reports will cover the complete method lifecycle," added Smith. It will provide a practical guidance for test methods from development through qualification into validation.