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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 |
|---|---|---|---|
| Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable. Zydus Lifesciences Limited |
05 May 2026 | Normal | Justification: Area cleaning efficacy is directly impacted by surface conditions that do not support standard cleaning operations. Excerpt: Floors within the Grade B cleanroom were visibly worn, peeling, and flaking in numerous locations. View Details |
| Written procedures are not followed for the cleaning and maintenance of equipment Bora Pharmaceuticals Injectables Inc |
20 Mar 2026 | Normal | Justification: Observation highlights area cleaning failure, compromising environmental controls essential to product sterility. Excerpt: Apparent disinfectant residue on the (b) (4) panels that encompasses the (b) (4) Vial Filler. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, Bora Pharmaceuticals Injectables Inc |
20 Mar 2026 | Normal | Justification: Deficient area cleaning procedures can lead to contamination risks, affecting the aseptic environment. Excerpt: Irregularly shaped fixtures mounted on the top section...are not readily cleanable with mop heads. View Details |
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Grifols Diagnostic Solutions |
13 Mar 2026 | Normal | Justification: The observation highlights deficiencies in cleaning validation, directly tying it to the Area Cleaning process. Excerpt: Disinfectant effectiveness validation studies were inadequate as they did not simulate actual worst-case conditions. View Details |
| You did not establish and follow written quality assurance procedures. Isorx Cyclotron Center |
13 Mar 2026 | Normal | Justification: Observation of unclean interventions and construction activities is directly linked to deficiencies in Area Cleaning. Excerpt: The firm has not conducted and documented thorough cleaning and disinfection of ISO-5, ISO-7, and ISO-8 classified areas... View Details |
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