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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. Immacule Lifesciences Private Limited |
18 Sep 2025 | Normal | Justification: The observation highlights ineffective contamination control practices, evidenced by improper sanitization and non-representative airflow studies. Excerpt: When wiping with the sanitizing agent, blue marker ink smeared onto surface; inadequate airflow pattern studies recorded. View Details |
| There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components Immacule Lifesciences Private Limited |
18 Sep 2025 | Normal | Justification: Removal of key air sampling steps affects control over microbial contamination. Excerpt: “...your firm eliminated the active air sampling before clearing the line for the assembly of machine parts...” View Details |
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions Fareva Amboise |
16 Sep 2025 | Normal | Justification: The observation points out failures in maintaining aseptic conditions and cleaning practices, which are directly linked to contamination control issues. Excerpt: There is no routine use of a sporicidal agent on equipment surfaces inside your Grade A filling barrier. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed Fareva Amboise |
16 Sep 2025 | Normal | Justification: Contamination Control is crucial as operators' actions directly affected sterile conditions. Excerpt: Operators reached under the barrier, transferred items without disinfection, and stored items improperly within Grade A areas. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process Fareva Amboise |
16 Sep 2025 | Normal | Justification: Inadequate airflow tests and aseptic validations are directly linked to Contamination Control issues. Excerpt: The quality unit approved airflow smoke tests...did not include adequate validation of the aseptic process. View Details |
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