International Journal of Drug Regulatory Affairs

32-36

Authors: 1Gupta Rajkumar

The sourcing of raw Gelatin for manufacturing hard Gelatin Capsules is a very critical function. It involves a thorough quality audit of the suppliers. The most critical audit points are: source of Gelatin used, quality control and quality assurance procedures, packaging system and storage conditions. In addition to these the facility shall be checked for domestic and international quality certifications and advance quality features.