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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic March 2 – 4, ... - page 15 / 15

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Chapter 12: Quality Control

Main Aspects

Release of batches must be certified by the authorized person

Retained samples of starting materials and products

Established, validated and implemented QC procedures

Evaluate, maintain, and store reference standards

Monitor stability of active ingredients and products

Complaint investigations related to quality of product

Environmental monitoring

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