Question 1
Testing alone cannot be used as the only measure of ensuring the quality of a product. The quality is based on the desired purity, strength, identity, and other characteristics. Hence, the FDA can only protect the average consumer by assuring the final good meets the criteria for effectiveness and safety. Otherwise, simply inspecting the international manufacturing facilities does not help the average buyer. The organization needs to establish a quality system that will oversee the measurements, evaluate and document the changes, and provide an action program that will address the issues that affect the product quality and performance (Buckley ...
