Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP<790> Visible Particulates in Injections

References

1. 1.↵
   U.S. Pharmacopeial Convention. General Chapter <771> Ophthalmic Products – Quality Tests. In USP 43—NF38, USP: Rockville, MD, 2022.
2. 2.↵
   U.S. Pharmacopeial Convention. General Chapter <790> Visible Particulates in Injections. In USP 43—NF38, USP: Rockville, MD, 2016.
3. 3.↵
   U.S. Food and Drug Administration. Draft Guidance for Industry: Quality Considerations for Topical Ophthalmic Drug Products, Docket No. FDA-2023-D-4177, Rev. 1; Issued December 2023.
4. 4.↵
   1. Cherris R.,
   2. Valley U.,
   3. Aabye-Hansen L.,
   4. McLean R.,
   5. Overroedder D.,
   6. Owen A.,
   7. Shabushniq J.,
   8. Aldrich S.,
   9. Veillon R.,
   10. Watson R.

   Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals; Parenteral Drug Association Inc.: Bethesda, MD, 2018.
5. 5.↵
   U.S. Pharmacopeial Convention. General Chapter <1788.2> Membrane Microscope Method for the Determination of Subvisible Particulate Matter. In USP 43—NF38, USP: Rockville, MD, 2021.
6. 6.↵
   American Society for Quality. ANSI/ASQ. Z1.4 Sampling Procedures and Tables for Inspection of Attributes. ASQ: Milwaukee, WI, 2013.
7. 7.↵
   1. Uemura O.,
   2. Sato H.,
   3. Terayama H.,
   4. Nitta H.,
   5. Ryokai J.,
   6. Namiki G.,
   7. Hattori H.,
   8. Sato H.

   Experimental Ocular Injuries Caused by Plastic Particulate Matter Possibly Contaminating Ophthalmic Solutions. Iyakuhin Kenkyu 1998, 29 (11), 793–807.

   OpenUrl
8. 8.↵
   1. Meyers V.,
   2. Garcia H.,
   3. Monds K.,
   4. Cooper B.,
   5. James J.

   Ocular Toxicity of Authentic Lunar Dust. BMC Ophthalmol. 2012, 12 (1), 26.

   OpenUrlPubMed