This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.
|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
about 10 years ago
Cell Line Quality Technologiesabout 10 years ago
Investigation Effectiveness Drives Human Performance Excellenceabout 10 years ago
Evaluating Technology and Innovation in Biopharmaceutical Manufacturingabout 10 years ago
Seeking Accelerated Biosimilar Characterizationabout 10 years ago
Plant-Made Pharmaceuticals—Accelerating Drug Development Globallyabout 10 years ago
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