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CURRENT GOOD MANUFACTURING PRACTICE (Evaluation Activities (Corrective…
CURRENT GOOD MANUFACTURING PRACTICE
Quality Unit
Quality Assurance
Auditing and performing/evaluating trend analyses
Review and approval of all procedures
Review of associated records
Quality Control
Evaluating performance of the manufacturing process
Assessing the suitability
Acceptability of each batch for release
Goals
improvements
harmonized
robust quality system
lowering the risk
high- quality drug product
Scope
finished pharmaceuticals
active pharmaceutical ingredients
products regulated
Quality Systems
Change Control
Corrective and Preventive Action
Product Development
Quality by Design
Quality Risk Management
Evaluation Activities
Corrective Action
Promote Improvement
Quality Risk Management
Preventive Actions
Analyze Data for Trends
Conduct Internal Audits
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