PTI - international

• Meet current FDA GMP expectations and avoid regulatory action
• Maintain compliance by correctly interpreting cGMP/GMP/QSR requirements
• Understand how GMPs apply to combination products
• Use PAT to develop innovative approaches and a real-time, continuous approach to quality
• Understand the FDA's risk-based approach to GMPs to ensure your compliance programs target the highest risk areas
• Implement proven strategies for process validation to enhance product quality and manufacturing process efficiency
• Establish and maintain beneficial audit programs to avoid FDA common trigger points
• Conduct effective failure and OOS investigations
• Utilize Failure Mode Effect Analysis (FMEA) to help identify and counter weak spots early in the development cycle
• Provide control within the laboratory to increase efficiency and productivity of lab operations
• Develop consistent and thorough GMP documentation that is ready and retrievable during an FDA inspection
• Establish effective change control and CAPA systems to account for errors and changes
• Train personnel effectively to understand GMP compliance and increase efficiency
• Properly maintain facilities and equipment within GMP's to help avoid delays due to contamination issues 

GMPs
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