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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 |
|---|---|---|---|
| Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product. Aurobindo Pharma Limited, Unit VII |
10 Feb 2026 | Normal | Justification: The issue fundamentally arises from inappropriate cleaning of equipment which is directly linked to Equipment Cleaning processes. Excerpt: The (b)(4) non-dedicated (b)(4) used... have not been appropriately cleaned since their installation several years ago. View Details |
| You did not ensure that all surfaces that contacted ingredients were cleaned and sanitized. Blendhouse Allerton, LLC |
22 Jan 2026 | Normal | Justification: Equipment Cleaning is involved as observation indicates a cleaning verification failure affecting operational cleanliness. Excerpt: Management acknowledged that the record did not indicate that the procedure was followed. View Details |
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment Excel Vision |
22 Jan 2026 | Normal | Justification: Equipment cleaning failures, particularly sterility, impact compliance in aseptic processes. Excerpt: Equipment including the (b)(4) machine contact parts are not sterilized. View Details |
| Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment Dabur India Limited |
16 Jan 2026 | Normal | Justification: Equipment Cleaning process failed, leading to representation errors and cleaned inadequately for multi-product use. Excerpt: The deliberate misrepresentation of equipment dedication, combined with the complete absence of cleaning validation... View Details |
| Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive Dabur India Limited |
16 Jan 2026 | Normal | Justification: The stagnant fluid in hoses used for cleaning indicates a failure in equipment cleaning processes. Excerpt: hoses connected to points of use in the Unit(b)(4) area and Unit(b)(4) manufacturing area were found to contain stagnant (b)(4). View Details |
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