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After almost two years of discussion and analysis, FDA is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics.
After almost two years of discussion and analysis, FDA is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics. The agency hopes to issue draft guidance by the end of the year that will outline a set of metrics indicative of a company’s ability to produce high quality products consistently. FDA sees quality metrics as supporting a range of initiatives for addressing drug shortages and recalls and for assisting manufacturers in preventing situations that could undermine quality operations.
The initial proposal is considering collection of data from manufacturers on annual lot rejection/acceptance rate; right-first-time rate; complaints received related to product quality; and invalidated out-of-specification results. To gain a broader measure of a manufacturer’s quality system, the draft plan also may examine on-time rate for annual product reviews, what level of management signs off on annual product reviews, whether an establishment calculates a process capability or performance index for critical quality attributes; and how an establishment’s Corrective and Preventive Action (CAPA) program operates.
FDA aims to publish a draft guidance outlining this program by the end of the year, according to Russ Wesdyk, scientific coordinator at the Office of Strategic Programs (OSP) in the Center for Drug Evaluation and Research (CDER), which has headed up this initiative under OSP director Theresa Mullin since it was announced in February 2013. An agency working group, which includes staff from OSP, the Office of Pharmaceutical Science, the Office of Compliance, and FDA’s Office of Regulatory Affairs, is developing the program. The working group will review comments on the draft guidance and hold public meetings to gain further input. The aim is to publish final guidance by the end of 2015 and initiate data collection in 2016. Manufacturers will have a year grace period to comply but could face regulatory action after that.
Data will be collected for manufacturing sites and by products, Wesdyk explained at last week’s FDA/PQRI conference on evolving product quality. FDA will issue overall results for industry, and also provide each manufacturer with a confidential score that then can be compared to industry averages-somewhat similar to SAT scores, in that the individual will see a specific score and also how it fits overall results.
In developing the program, the FDA working group has solicited and reviewed white papers from manufacturers on what data they currently collect and what metrics they consider most valuable. In submitting proposals to FDA, the International Society for Pharmaceutical Engineers (ISPE), the Parenteral Drug Association (PDA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA) have addressed different aspects of this broad initiative, clarified definitions of key terms, and emphasized the need to take a balanced approach to assessing quality production. A second PDA workshop in December will further examine the attributes and measures of a “quality culture.” Ideally, this initial set of metrics will lay the basis for further harmonization of quality standards on a global basis.