Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.
|Articles|October 15, 2016
- BioPharm International-10-15-2016
- Volume 2016 eBook
- Issue 2
Data Integrity Challenges in Manufacturing
Author(s)Jennifer Markarian
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
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Manufacturing systems should be designed using the principles of good documentation practice to ensure data integrity. Industry experts describe issues with validating, using, and auditing paper and electronic records. Records must meet the core principles of ALCOA+ (data must be attributable, legible, contemporaneous, original, accurate, complete, consistent, and enduring).
Articles in this issue
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Cell Line Quality Technologiesalmost 10 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 10 years ago
Evaluating Technology and Innovation in Biopharmaceutical Manufacturingalmost 10 years ago
Seeking Accelerated Biosimilar Characterizationalmost 10 years ago
Plant-Made Pharmaceuticals—Accelerating Drug Development Globallyalmost 10 years ago
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