QUALITY SYSTEMS, REGULATORY SERVICES & ENVIRONMENT MANAGEMENT SYSTEMS

• ICH Q7 GMP SYSTEMS, EU GMP (Eudralex Guidelines part II)
• STANDARD OPERATING PROCEDURES ON SITE FOR MANUFACTURING PROCESSES
• ANNUAL PRODUCT REVIEW
• CHANGE CONTROLMECHANISMS
• MARKET COMPLAINT CAPA AND FEEDBACK
• PRODUCT RECALL, RETURN GOODS, REPROCESS, REWORKS
• MATERIAL MANAGEMENT
• CRITICAL DEVIATION MANAGEMENT (CDM) AND INVESTIGATION
• OUT OF SPECIFICATIONS (OOS) INVESTIGATION
• OUT OF TREND (OOT) INVESTIGATION
• RAW MATERIAL VENDOR SELECTION, QUALIFICATION AND APPROVAL
• TRAINING

VITAL has adopted the "International Conference on Harmonization (ICH) Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients," representing their own regulations for the manufacturing of APIs. These regulations substantiate and even extend the WHO requirements. VITAL as API’s manufacturers achieves regulatory compliance and avoids production stoppages and recalls by following the guidance issued by the Food and Drug Administration (FDA) and the European regulatory agencies. In addition, VITAL also understands that education and training are a key business investment that shall produce safe and effective products in the long run.
 
VITAL HAS A SELF MANAGED EFFLUENT TREAMENT PLANT AND AN ENVIRONMENT MANAGEMENT SYSTEM ADOPTED FOR ACCREDATION OF ISO 2008-22000 SYSTEMS AND HACCP (HAZARD ANALYSIS AND CRITICAL CONTROL POINTS). HACCP is a systematic method followed by VITAL to analyze and to identify undesirable / hazardous inclusion of chemical, physical, or biological agents into manufacturing systems. It is the expectation, if not a requirement, that organizations operating within the API’s supply chain to identify, analyze, and to prevent, eliminate, reduce (or mitigate) these hazards (dangers) to acceptable levels. The principles of HACCP are endorsed by the United Nations through USA FDA and carry over to European Union, Canada, Australia, New Zealand, Japan and others.