Key trends in OTC products
OTC products are required to be tested as per the monograph listed in the Pharmacopeia. All the parameters are to be tested depending on the dosage form (Tablets, capsules, Liquid, etc.) If the product is not given in the Pharmacopeia then in house method must be developed and validated.
Part of the trends include leveraging existing Big distributed data (protecting privacy and personal information) throughout health centers, pharmacy centers, geographical/demographic segments. This data combined with application of Machine Learning (about consumption, production, sources, and outcomes), and with ongoing product testing (of new or sustaining formations) build up knowledge for health providers, researchers, pharmaceuticals, and regulatory institutions like FDA to lead into new or better decisions.
the biggest trend in testing will be reporting quality metrics to FDA. The draft guidance has listed volunteer information submissions, but with any similar request, we all know it will become mandatory. You can also review 483 trends. What I see are issues with purified water systems (related testing), data integrity, software validation, sufficient procedures and specifications, proper registration, and CAPA / investigation management.