FDA Seeks Feedback on Standardisation of Pharmaceutical Quality, CMC Terminologies
The United States Food and Drug Administration (FDA) is proposing to standardise data elements and terminologies related to pharmaceutical quality and chemistry, manufacturing and controls (PQ/CMC).
Regulatory officials think standardization will enable them to convert the manufacturing and testing data companies submit into an easy-to-use electronic format. This will further its move toward filings in a specified electronic format — which was mandated by the Food and Drug Administration Safety and Innovation Act in 2012 — and continue the digital transition that began in 2004 with the electronic labelling rule.
The FDA predicts standardization will make the drug review process more efficient while raising standards. This claim is based on a belief consistency in the content and format of PQ/CMC data will make it easier for FDA reviewers to query submissions.
To realize these benefits the FDA is creating a standardized data dictionary. The FDA has begun the process by creating tables of PQ/CMC data elements. These tables name and define data elements.
For example, the data element “test usage” is defined as “a coded value specifying the time point during the manufacturing process of a substance or product when a particular analytical procedure or measurement is being performed.”
The FDA has put together 15 tables of such definitions. The tables are grouped by topic, such as test, acceptance criteria and batch information. Another section of the document details controlled terminology defined by FDA experts.
Having created the definitions, the FDA now wants to gather the views of people working in CMC and pharmaceutical quality. The agency specifically wants to hear the industry’s views on the accuracy, suitability and appropriateness of the data elements and their definitions.
The comment period is open until September. Once the comment period closes, the FDA will assess how to take the data element standardization project forward.