Beruflich Dokumente
Kultur Dokumente
Quality Control
1
QUALITY CONTROL FOR REGULATED
ENVIRONMENTS
UNIVERSITY OF HOUSTON
Introduction
2
Specifications
3
Raw materials
In process control
Intermediary compounds
Drug substance and drug product
Analytical methods
5
Analytical Methods
6
Reference materials
7
Quality Assurance
Ensure the manufacturing and laboratory operations are
compliant with cGMP practices
Approve and reject raw materials and product batches
Quality Control
Testing of raw materials, in-process materials and final
products
Developing, validating, and performing assays
Providing analytical support for validation and
environmental monitoring programs
Quality Organization
9
Safe
Quality Assurance is