Risk and quality management ? a supplier?s perspective

The report includes steps the agency has taken and will take to develop and implement a risk-based product quality regulatory system and quality systems management.

Included in the report is draft guidance on the role of quality systems in the pharmaceutical cGMPs that enable manufacturers to tailor their quality system to fit their specific manufacturing environment.

From a packaged equipment supplier?s point of view, the impact of a risk-based, quality management system ranges from minimal to severe.

Includes:
Managing the supply chain
The price of quality
The part number jungle