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A SEMINAR ONPROCESS VALIDATION OF OINTMENT/CREAM FORMULATION
Why need of process validation for ointment/cream?
• • • • Product bio burden high? Multiple component? More adequate preservative system? All have Newtonian flow behavior?
• History: Zinc oxide rash cream that was heated to a relatively high temperature solely by the action of rotating mixing plate.
Ointment
• Soft, semisolid preparation intended for application to skin and mucus membrane.
Cream
• Viscous emulsion of semisolid consistency intended for application to skin and mucus membrane. Appearance: Translucent Type: oil-in-water(o/w) water-in-oil(w/o)
Appearance: Opaque
Type: Oleaginous bases Absorption bases Emulsion bases Water soluble bases
● Processes must be validated in pharmaceutical manufacturing are:
• • • • • • • • • • • Cleaning Sanitization Fumigation Depyrogenation Sterilization Sterile filling Fermentation Bulk production Purification Filling, capping, sealing Lyophilization
Process Validation
• Documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specification and quality characteristics.
Process Validation Program
cont..
Process validation
• WHY ENFORCE IT? • WHEN IS IT PERFORMED? • WHO PERFORMS IT?
Why?
• Makes good engineering sense. • Results in fewer product recalls and troubleshooting assignments in manufacturing operations.
• Results in more technically and economically sound products and their manufacturing processes.
When?
Development stage Product design Product characterization Formula selection Process design Product optimization Process characterization Process qualification Process demonstration Process validation program Product / process certification 1X batch size 1X 1X 1X 10x batch size 10X 10x 100X batch size 100x 100x Batch size
Who?
• • • • • • • • • Formulation development Process development Pharmaceutical