Develop

• Specifications - based on process capability, stability performance, regulatory expectations
• Test Methods - focused on separation of process impurities and degradation products of actives and excipients
• Validation Protocols - meeting current guidelines and laboratory practices
• CAPA Systems - for tracking responsibility and completion of corrective and preventive actions

Implement

• Change Management - local and centralized systems based on nature and impact of change
• Laboratory Investigations - clearly define the issue and determine the root cause
• Documentation Control - insure that only current versions of documents are used in the laboratory
• Training programs - laboratory practices, SOP updates, periodic GMP and GLP reviews

Analyze

• Test Results - confirm routine accuracy and precision consistent with validation, testing consistent with current compendia
• Trends - distinguish changes in process capability and testing differences
• Statistics - determine significance of variations in test results, stability parameters
• Data Integrity - review data handling and storage practices, approval process, audit process