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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, written and followed. Apothecary Pharma LLC |
15 May 2025 | Normal | Justification: Area Qualification impacts were noted where procedural adherence within ISO 5 environments failed. Excerpt: Operators rest forearms on ISO 5 bench and lean their heads into the hood. View Details |
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Apothecary Pharma LLC |
15 May 2025 | Normal | Justification: Area Qualification is key here as the failure pertains to overlooking of certification reports necessary for cleanroom validation. Excerpt: Failure to review Certification Report Control ID #4049-339748-64877 for cleanroom validation. View Details |
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. PQ Pharmacy LLC |
04 Apr 2025 | Normal | Justification: Area Qualification is impacted by improper execution and review of environmental conditions. Excerpt: Smoke Studies conducted in September 2024 appear to exhibit turbulence in the Non-hazardous Cleanroom 1 ISO-7 area. View Details |
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces. Thrive Health and Wellness, LLC, dba Thrive Health Solutions |
03 Apr 2025 | Normal | Justification: Area Qualification is essential due to the use of unqualified spaces for sterile production, increasing contamination risks. Excerpt: Unclassified room that contains potential contaminants; room also serves as an office. View Details |
Lack of a certified ISO-5 classified area for sterile compounding Thrive Health and Wellness, LLC, dba Thrive Health Solutions |
03 Apr 2025 | Normal | Justification: Area Qualification directly relates to the need for ISO-5 classified environments for sterility control. Excerpt: Your firm fills syringes intended for subcutaneous injection by withdrawing sterile solution from vials on a benchtop table, located in an unclassified room. View Details |
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