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Stability Studies
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| You assign the storage conditions and retest or expiry dates of the APIs using test procedures that are not stability indicating. Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The observation highlights flaws in determining API shelf-life, directly pertaining to the Stability Studies process. Excerpt: You assign the storage conditions and retest or expiry dates of the APIs using test procedures that are not stability indicating. View Details |
| There is no written testing program designed to assess the stability characteristics of drug products. ProRx LLC |
02 Aug 2024 | Normal | Justification: Stability Studies are directly related to the observation as the issue pertains to the lack of stability testing to support expiration dates. Excerpt: There is no written testing program designed to assess the stability characteristics of drug products. Specifically, your firm does not have a written stability program that supports the expiration of your sterile and non-sterile drug products. View Details |
| An on-going testing program to monitor the stability characteristics of APIs is not established and followed Global Calcium Pvt. Limited |
02 Aug 2024 | Normal | Justification: The observation directly relates to the failure in maintaining an established stability testing program for APIs. Excerpt: An on-going testing program to monitor the stability characteristics of APIs is not established and followed. 2023 yearly stability samples could not be located. View Details |
| The written stability testing program is not followed BSO LLC |
03 Jul 2024 | Normal | Justification: Stability Studies are implicated due to the lack of stability data supporting product shelf life. Excerpt: Lacks stability data to support the 360-day BUD for Anastrozole. View Details |
| There is no testing program designed to assess the stability characteristic of drug products. Torrent Pharmaceuticals Limited |
12 Jun 2024 | Normal | Justification: Stability Studies are fundamentally linked because they ensure that drug products remain stable within their shelf life, which was neglected. Excerpt: None of these valid OOT batches were charged on stability and monitored throughout the shelf life. View Details |
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