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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 |
|---|---|---|---|
| Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions Empower Clinic Services, L.L.C. dba Empower Pharma |
14 Nov 2025 | Normal | Justification: The observation is directly linked to 'Area Cleaning', as failure in executing cleaning protocols led to potential contamination. Excerpt: Per the firm's procedure ... cleaning shall be completed prior to the formulation of different active sterile injectable lots. View Details |
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment Fresenius Kabi Compounding, LLC |
06 Nov 2025 | Normal | Justification: The observation highlights deficiencies in cleaning tasks related to maintaining aseptic conditions. Excerpt: A brown, rust-like residue was observed on the (b) (4) of multiple tables and laminar flow hoods... 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 highlights procedural errors during area cleaning affecting aseptic conditions. Excerpt: Operators did not use a unidirectional wiping technique or clean and disinfect the area in the product flow direction. View Details |
| Written sanitation and facility maintenance procedures are not established or followed Biocon Biologics Limited |
03 Sep 2025 | Normal | Justification: Observation mentions 'soiled mop labeled as Grade D Area Cleaning' and 'standing liquid puddles,' highlighting an Area Cleaning issue. Excerpt: A soiled mop labeled as "Grade D Area Cleaning" within the Grade C room and liquid standing puddles. View Details |
| Personnel practices within the facility do not adequately prevent microbial contamination of drug product. Not available |
01 Aug 2025 | Normal | Justification: Area Cleaning is compromised, shown by contaminants like skin flakes and hair in critical zones. Excerpt: Hair follicles and skin flakes were present in the Grade A aseptic processing area... View Details |
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