Methods for validating medication
The present disclosure provides methods and systems for providing a validated drug product to an end-user or distributing business. Also provided herein are methods and systems for providing a certificate of analysis for a drug product to provide more information to a user.
1 . A method for validating a plurality of medication batches post-manufacturing, the method comprising:
(a) obtaining at least one sample from the plurality of medication batches post-manufacturing, wherein each medication batch post-manufacturing of the plurality of medication batches post-manufacturing comprises a same active ingredient from the same manufacturer;
(b) performing an analytical test on the at least one sample from the plurality of medication batches post-manufacturing to determine one or more analysis result;
(c) determining a validation status of the plurality of medication batches post-manufacturing based on at least one of the one or more analysis result; and
(d) providing an indication of the validation status of the plurality of medication batches post-manufacturing to a drug manufacturer, a distributor, a pharmacy, a medical professional, a government agency, or an end user.
2 . The method of claim 1 , wherein the analytical test comprises at least one analytical test selected from the group consisting of: nuclear magnetic resonance spectroscopy, mass spectrometry, high-performance liquid chromatography, Fourier transform infrared spectroscopy, and Raman spectroscopy.
3 . The method of claim 1 , wherein the indication of the validation status is provided on a report.
4 . The method of claim 3 , wherein the report comprises an indication of one or more of: analytical tests performed on the at least one sample from the plurality of medication batches post-manufacturing, a number of ingredients analyzed, adherence to a quality standard, deviation from a reference quantity, dissolution test results, or any combination thereof.
5 . The method of claim 3 , wherein the report comprises an indication of indicates one or more-impurities present in the at least one sample from the plurality of medication batches post-manufacturing.
6 . The method of claim 1 , wherein the at least one sample from the plurality of medication batches post-manufacturing is in a solid form selected from the group consisting of: a pill, a capsule, a tablet, and a powder.
7 . The method of claim 1 , wherein the at least one sample from the plurality of medication batches post-manufacturing is in a non-solid form selected from the group consisting of: a liquid, a cream, a lotion, a paste, and a gel.
8 . The method of claim 1 , wherein the at least one sample from the plurality of medication batches post-manufacturing is a sample selected from the group consisting of: a drug prescribed by a licensed healthcare practitioner, a drug purchased over-the-counter, a drug purchased over the internet, a drug acquired from a manufacturer, and a drug acquired from a distributor.
9 . The method of claim 1 , wherein the at least one sample from the plurality of medication batches post-manufacturing is taken from a container or package containing more than one unit of a medication batch of the plurality of medication batches post-manufacturing.
10 . The method of claim 1 , wherein the at least one sample from the plurality of medication batches post-manufacturing comprises a biologic, a pharmaceutical, a veterinary drug, or any combination thereof.
11 . The method of claim 1 , wherein performing the analytical test of (b) comprises techniques for identifying chemicals, techniques for verifying the integrity of pharmaceutical products, or both.