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Sample Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | 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 issue is fundamentally connected to the improper handling and management of stability samples. Excerpt: 2023 yearly stability samples for batch could not be located. View Details |
| Established impurity profiles for US market APIs are inadequate Global Calcium Pvt. Limited |
02 Aug 2024 | Normal | Justification: Ensuring that sample batches are thoroughly analyzed and documented is critical to quality control. Excerpt: Impurity profiles describing the identified and unidentified impurities present in a typical batch of US market APIs have not been established. View Details |
| Established sampling plans and test procedures are not followed Zydus Lifesciences Limited |
23 Apr 2024 | Normal | Justification: This process type is directly linked to the observation due to the explicit mention of failure in collecting scheduled samples as per established SOPs and the falsification of records to indicate sample collection, which falls under the realm of sample management. Excerpt: Procedures 0317-SOP-QC-00193 "Sampling and Testing procedure of and 0317-SOP-QC-00118 "Quality monitoring of System" were not followed for collecting samples. Scheduled samples for specified sample points were not collected. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures Catalent Indiana, LLC |
15 Nov 2023 | Normal | Justification: Sample Management is directly linked to the observation as the issue revolves around the inadequate validation of sample storage conditions, which is a critical aspect of managing samples in the laboratory. Excerpt: There is a failure to validate the endotoxin sample storage of drug products under project code(b) (4) at(b) (4) up to (b) (4) prior to the testing. View Details |
| Established sampling plans are not documented at the time of performance. Central Admixture Pharmacy Services Inc |
25 Aug 2023 | Normal | Justification: Proper sample management includes immediate and accurate documentation to ensure traceability and quality control, which was lacking as observed. Excerpt: The Chemistry laboratory technician did not record this activity on FRM-CAPS-4000246 form, titled "FRM Quality, Potency Analysis by HPLC Form". View Details |
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