Quality Assurance

• Quality Manual/Quality Review/Annual Product Review
• Written Specifications for materials & components
• Standard Operating Procedures (SOPs)
• Method Validation/ Process Validation/ Vendor Validation
• Equipment Validation (IQ/OQ/PQ)
• Batch Record Review
• Self Audit/ Change Control/ Document Control
• Management of corrective and preventive actions (CAPA)
• GMP Training