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Posted 04 November 2013 | By Alexander Gaffney, RAC,
European regulators have announced that they, along with the US Food and Drug Administration (FDA), have released a second question-and-answer document intended to provide guidance to industry on the concept of "quality by design," or QbD.
The QbD concept is well-known within most regulatory circles. Simply stated, it is the belief that quality should be designed-not tested-into the final product, including its manufacturing processes. In theory (and regulators say in practice as well), this results in fewer compliance problems because a manufacturer addresses problems before they exist, and more systematically when they occur.
In the pharmaceutical sector, QbD concepts are broadly incorporated into the regulatory systems of any region that uses the International Conference on Harmonisation (ICH) and its Q8, Q9, Q10 and Q11 documents.
Both FDA and the European Medicines Agency (EMA) have been pushing QbD concepts heavily in recent years.
"CDER is focusing on ways of improving its assessment of quality," said Howard Sklamberg, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance, at the 2013 RAPS conference in Boston. "We're in the process of forming an Office of Pharmaceutical Quality (OPQ)," which would combine many review functions-good manufacturing practices and chemistry, manufacturing and controls, for example-that are currently spread throughout various CDER offices into one office."
The goal, Skalmberg said, is to adopt a "lifecycle approach to reviewing products," much in the same way that regulators within industry often work.
Richard Friedman, associate director of the Office of Manufacturing and Product Quality, also within the Office of Compliance, elaborated on the importance of quality at the same conference. Asked Friedman, "We must ask ourselves, in an area where the stakes are so high, why are high degrees of quality not being achieved?"
In March 2011, EMA and FDA announced the launch of a pilot program they said was intended to allow them to better communicate review findings with respect to QbD elements of applications chosen for review. Regulators said the pilot program is meant to allow simultaneous review by both regulators of certain aspects of the application-in this case, QbD elements-allowing for an expedited and more thorough review process.
Under the program, applications "are submitted to either both agencies at the same time resulting in a parallel evaluation, or either to EMA or FDA in which case the agency doing the evaluation obtains consultative advice from the other agency," EMA wrote in its Q&A document.
"This parallel assessment aids sharing of regulatory decisions and facilitates the availability of consistent quality pharmaceutical products throughout the US and EU," FDA wrote in a statement.
In August, EMA and FDA released a question-and answer document with advice on several aspects of the QbD process based on what they had learned through their participation in the pilot to date.
Some of the initial advice regarded:
At the time, both regulators said additional Q&A documents would be forthcoming, and now a second Q&A document has been released. The slightly longer three-page document contains nine questions and answers, including:
As with the August 2013 document, EMA and FDA said further Q&A documents will be released in the future.
FDA/EMA Q&A Report
EMA Press Statement
Tags: Latest News, Quality by Design, QBD, guidance, EU
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