Norac Pharma has a state-of-the-art cGMP Compliance Program incorporating the latest FDA and ICH guidelines for Active Pharmaceutical Ingredients (API), Laboratory Controls, Validation Methodology, and Stability Testing Programs.

Norac Pharma has a staff of highly trained Quality Assurance and Quality Control personnel with modern quality systems in place for all facets of operation, from control and release of starting materials to comprehensive batch review and approval of final API products. A proactive Quality Assurance and Quality Control presence throughout the pharmaceutical operations ensures that all requirements and expectations of the customer and regulatory agencies are fully met.

Norac Pharma has expertise in the following Quality Systems:

• Change Control Management System

• Document Control

• Training Program

• Internal Audit Program

• Supplier Qualification Program

• Raw material and Components Control and Release

• Label Control

• Investigation and prompt resolution of Deviations

• Investigation and Handling OOS and OOT results

• Validation Master Planning

• Equipment Qualifications

• Process Validation

• Cleaning Validation

• Validated Water and Utilities Systems

• Environmental Monitoring

• Preventative Maintenance and Calibration Program

• ICH compliant Stability Programs

• ICH compliant Method Validation Program

• Technology Transfer and Scale Up