The Role of QbD in ANDA Review Draws Comment from Generics Office Management

FDA’s Office of Generic Drugs (OGD) is advising industry that consistency around key quality-by-design (QbD) terminology will help release the potential of QbD to facilitate the Abbreviated New Drug Application (ANDA) review process.

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In a presentation on the growing importance of QbD to the generic drug development and approval process at a CMC workshop co-sponsored by the Generic Pharmaceutical Association (GPhA) and FDA in late May in Bethesda MD, OGD Science and Chemistry Director Lawrence Yu stressed the amount of work that went into clarifying the definitions of critical material attribute (CMA), critical process parameter (CPP) and critical quality attribute (CQA), in particular.

“We went through a lot of discussions internally” and received industry input during “a number” of roundtable discussions on these key QbD terms, he reported.

“For any pharmaceutical unit operation, the input material attributes are called CMAs if they are critical,” Yu explained.  “For outputs, we call them CQAs.  Any process parameter that could potentially impact the quality of the output material we call a CPP.”

Recognizing that ICH allows the term CQA to be used for an input material, Yu pointed out that “if you want to define it this way, that is OK – I have no issue with that.  But when you use CQA, you have to say of what.  For example, for compression, if you talk about mixture uniformity, it needs to be the uniformity of the input mixture material.  You cannot just call it a CQA or we will be confused.  If you call them material attributes, we know that is for input materials.”

The importance of the changes FDA is making to its generic drug review process was marked by the attendance of 300 industry and regulatory representatives from around the world at the workshop and a sizable waiting list.

The meeting included presentations by OGD on the key issues on which the staff is currently focused, including: ● elements of quality by design ● the refinement of the question-based review (QbR) process (IPQ “The News in Depth” August 22, 2012) ● product and process understanding ● risk assessment ● the drug master file (DMF) and drug substance review ● control of starting materials, and ● stability expectations.

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See related stories:

FDA’s Generics Office is Revising its QbR Questions to Sharpen Focus on QbD and Control Strategy

FDA Generic Drugs Office Advances QbD, Review Processes and Quality Management System in Anticipation of User Fees

IPQ Special Report May 2010, pp. 17-19