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Method Validation
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Test procedures is not scientifically sound and appropriate to ensure that raw materials, intermediates, and APIs, conform to established standards Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The observation mentions an inhouse test method which is not validated, directly linking to method validation lapses. Excerpt: A review of the corresponding Analytical Method Validation Report confirmed that the method is not validated for impurities. View Details |
| The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. Cipla Limited |
21 Jun 2024 | Normal | Justification: Validation ensures the accuracy and reproducibility of test methods, which is critical for product quality. Excerpt: The following commercial drug products test methods, including in-house and compendial test methods, were not validated, verified or transferred appropriately. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Biocon Biosphere Limited |
14 Jun 2024 | Normal | Justification: The major issues are resultant from inadequate validation procedures, affecting reliability and compliance of test methods. Excerpt: The microbial enumeration test method validation titled "Study Report to Perform the Method Suitability... does not include the strain Aspergillus brasiliensis... The test method for (b) (4) identification testing does not include gas chromatography analysis for the limit of (b) (4). View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures Hikma Pharmaceuticals USA Inc. |
12 Jun 2024 | Normal | Justification: Method validation is directly affected as the observation highlights missing validation characteristics, which are crucial for ensuring test reliability. Excerpt: omits established characteristics for conducting a method validation, such as but not limited to, Accuracy and instrument comparability. View Details |
| Analytical methods were not validated or verified under the actual conditions of use. Dr. Reddy's Laboratories Limited |
07 Jun 2024 | Normal | Justification: The observation directly mentions the failure to validate and verify test methods under actual conditions, which is a core aspect of method validation. Excerpt: The following test methods, including in-house and compendial test methods, were not validated or verified appropriately for the commercial APIs. View Details |
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