Validation-related Issues

Approach to validation
SOPs
Calibration
Environmental monitoring
Preventive maintenance
Training
Raw material sampling and qualification programs
Change control
Facilities/systems
Manufacturing/packaging methods
Formulations
Raw materials & Suppliers
Cleaning Procedures
Computer and control systems
• Problems seen recently are similar to ones in past
• Validation issues - one of top two reasons for
deficiency notices
– Protocols are not followed
– Inadequate (insufficient testing, lack of specs, etc.)
– Retrospective validation - changes occurred within
sequence
– Inadequate change control, revalidation program
– Older products - bringing up-to-date is difficult

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