The technical reference document released Friday from the US Food and Drug Administration (FDA) provides recommendations to pharmaceutical companies on the submission of records and other information to support FDA’s calculation of quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment.
The 10-page guide follows the creation of an Office of Pharmaceutical Quality, the release of draft guidance for industry, known as “Request for Quality Metrics” from July 2015, and is intended to ensure clear expectations for industry on the submission of quality metrics data as described in the draft guidance, for which FDA said it is still reviewing comments and may update.
“Our goal is to institute efficient regulatory review, compliance oversight, and inspection policies established on risk-based methods, including quality metric reporting,” the agency said. “Due to the inherent variability among reporting establishments’ implementation of the process validation lifecycle and PQS assessment, it is difficult to identify and compare quality issues between firms. As such, FDA recognizes the importance of industry input and agreement regarding standardized indicators of manufacturing and product quality.”…
read more of it here: Source: Quality Metrics: FDA Outlines What Data to Submit | RAPS