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Process Validation
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| There is a failure to ensure that manufacturing processes are maintained in a validated state. Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Failure to maintain a validated process state directly relates to 'Process Validation' due to recurring OOS results. Excerpt: no holistic review, effective measures and/or assessment performed to ensure that the process is under adequate control View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written. Nephron Sterile Compounding Center LLC |
25 Sep 2024 | Normal | Justification: Validation processes must include thorough investigation and documentation of anomalies and testing failures. Excerpt: You will not investigate if that (b) (4) passes the (b) (4) as to why the (b) (4) failed. View Details |
| The process of material from the commonly performed ... has not been adequately assessed to ensure that material obtained from this process is of suitable quality prior to further processing. Granules India Limited |
06 Sep 2024 | Normal | Justification: The observation highlights deficiencies in evaluating material quality during and after the manufacturing process, which is directly related to process validation. Excerpt: There has been no documented scientific evidence that the material (b) (4) and collected meets the minimum (b) (4) in-process check of other material prior to (b) (4) including during evaluation of samples from (b) (4) the most recent process validation. View Details |
| The process of material from the commonly performed (b) (4) during routine manufacturing, including used in (b) (4) ontaining drug products for the US market, has not been adequately assessed to ensure that material obtained from this process is of suitable quality prior to further processing. Granules India Limited |
06 Sep 2024 | Normal | Justification: Process validation ensures materials used meet quality standards, supported by regulation in procedure GGMF194. Excerpt: There has been no documented scientific evidence that the material (b) (4) and collected meets the minimum (b) (4) in-process check. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. Granules India Limited |
06 Sep 2024 | Normal | Justification: Observation mentions failure in process validation, directly linked to process validation methods. Excerpt: Your OOS and OOT Investigations for Process Validation (PV) batch # 3rd batch of PV) are not (b) (4). View Details |
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