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Quality Considerations for Topical Ophthalmic Drug Products Guidance for Industry DRAFT GUIDANCE

  • 1.  Quality Considerations for Topical Ophthalmic Drug Products Guidance for Industry DRAFT GUIDANCE

    Community Leadership
    Posted 10-16-2023 17:18

    I did go through the Draft Guidance for Quality Considerations for Topical Ophthalmic Drug Products Guidance for Industry. FDA has requested Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. I as a retired, former USFDA/CDER/OPQ/OPMA Senior CMC Reviewer going through the draft guidance I found this has covered only the Quality Control aspect of Topical Ophthalmic Drug Products for finished stage. However, there is nothing about quality assurance i.e., by QbD (quality by design). Where in the manufacturing of such drug product what a reviewer not just of OPQ/OLDP going through QC of the product but also OPMA reviewer to find was the process and manufacturing followed by QbD aspects for the filed ANDA from the applicant/manufacturer to maintain the quality during the manufacturing process. So, the end product meets all its quality requirements. As FDA has asked Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. I have therefore submitted a request to include such QbD points into this guidance for the Topical Ophthalmic Drug Products Guidance for Industry to consider during manufacture of the drug product available in the application. FDA/CDER/OPQ/OPMA managements should look into this very needed inclusion in the guidance.

    I would appreciate other members of Manufacturing Science and Engineering Community to go through this new FDA draft guidance on "Quality Considerations for Topical Ophthalmic Drug Products Guidance for Industry" and give their comments from Process & Manufacturing QbD point of view otherwise the new guidance will be just by Quality Control only. I have proposed/suggested a tabulated draft guidance to include Critical Material Attributes, Critical Process Parameters, Critical Quality Attributes and Additional points to be included in the Batch Manufacturing Records by the Applicants.

    Thanks.

    Masih Jaigirdar



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    Masihuddin Jaigirdar
    Pharmaceutics Expert (FDA & Industry Sector)
    MJ Consultant
    Silver Spring MD
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.MasihuddinMasihuddinMasihuddinMasihuddin
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