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The core of good biopharmaceutical manufacturing is accurate data.
Competitive pricing and continued cost pressures have contributed to the need for many US biopharmaceutical companies to outsource manufacture of active pharmaceutical ingredients (API) and finished products from countries with lower costs for labor, material, and equipment.
The main benefit of doing so is lower costs of manufacturing with quality standards comparable to those found in the United States.
Part 210 governs CGMP for manufacturing, processing, and packaging or holding drug products.
Part 211 describes the CGMPs for finished pharmaceuticals.
India and China now account for 80% of API production.
But those countries have received media attention because of biopharmaceutical manufacturing issues.
Even minor changes can make the difference between a high- and poor-quality drug product, so each step in a process must be recorded and validated.
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