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A Contamination Control Strategy Gone Wrong.pdf

9-21-IVT Network - A Contamination Control Strategy Gone Wrong - 2022-04-06.pdf

Preview of A Contamination Control Strategy Gone Wrong

🔗 Source: bpi.bioprocessintl.com

📊 Size: 87 KB

📄 Pages: 3 pages

⬇️ Downloads: 63

Summary

A vaccine production facility received an FDA 483 report due to contamination control issues. The report highlighted several problems, including:
1. Inadequate investigation of potential cross-contamination, with insufficient consideration of operator actions and equipment use.
2. A leak was observed, and a recipe was aborted without a procedure in place, leading to insufficient investigation of product impact.
3. Logbook entries indicated repairs were made, but no investigation was conducted to assess the impact on product quality.
4. The manufacturing site was not maintained in a clean and sanitary condition, with issues such as peeling paint, unvalidated decontamination methods, and inadequate waste management.
5. The building used for manufacturing was not of suitable size, design, or location, with inadequate decontamination facilities, overcrowded hallways, and insufficient doorway sizes.

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Description

A vaccine production facility received an FDA 483 report due to contamination control issues. The report highlighted several problems, including:
1.

Technical Information

File Format: PDF
File Size: 87 KB
Pages: 3
Language: EN
Total Downloads: 63
Last Updated: 6 hours ago

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