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# Comments on Quality Metrics Technical Guidance
- URL: https://www.fdaweb.com/comments-on-quality-metrics-technical-guidance/
- Published: 2016-09-29T12:00:00.000Z
- Updated: 2026-09-14T21:35:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136950

Pharmaceutical Research and Manufacturers of America says in a comment [letter](https://www.regulations.gov/document?D=FDA-2016-D-1594-0010&ref=fdaweb.com) on an FDA draft guidance on quality metrics technical conformance that it commends the agency’s innovative vision to harness its new authorities under the FDA Safety and Innovation Act to use quality metrics reporting in risk-based scheduling of drug manufacturing establishments. The trade association says that to date industry has devoted considerable time determining how quality metrics can be defined and used by industry and FDA to transform regulation of drug manufacturing quality. The letter offers general comments on: 

- relationship of the quality metrics technical conformance guide to the request for quality metrics draft guidance;
- continued alignment and collaboration across FDA:
- IT infrastructure and validation; and
- data security and confidentiality.

The group also provided specific technical comments.

Baxter [asks](https://www.regulations.gov/document?D=FDA-2016-D-1594-0009&ref=fdaweb.com) for an opportunity to evaluate the potential to harmonize this draft with the CDRH metrics effort since it appears that both programs are trying to accomplish similar results. It also asks for a single document clarifying all definitions.

The International Society for Pharmaceutical Engineering [says](https://www.regulations.gov/document?D=FDA-2016-D-1594-0003&ref=fdaweb.com) that additional detail and clarity as discussed in its specific comments would be beneficial in areas such as technical specifications, definitions, and format for XML data submission.

Sanofi’s [letter](https://www.regulations.gov/document?D=FDA-2016-D-1594-0006&ref=fdaweb.com) says it understands that FDA plans to issue revised draft guidance on submission of quality metrics data and asks that, as needed, the technical conformance guide be amended to reflect the contents of the revised draft comments and then be released again for public comment.

Finally, the Parenteral Drug Association (PDA) [suggests](https://www.regulations.gov/document?D=FDA-2016-D-1594-0007&ref=fdaweb.com) that to streamline implementation and maximize learning, FDA “provide a pilot or ‘sandbox’ where companies could make example submissions and receive FDA feedback on whether the response meets expectations. PDA further recommends FDA engage in collaborative dialog on preparing the validation rules for these data sets rather than waiting to disclose the rules once finalized.”