Semisolids

A pharmaceutical dosage form category that

includes ointments, cream emulsions, pastes, gels,

and rigid foams.

Their common property is the

ability to cling to the surface of application for

reasonable duration before they are washed or

worn off.

The adhesion is due to plastic rheologic

behavior, which allows the semisolid to retain

shape and cling as a film until acted upon by an

outside force, in which case it will deform and flow.

Validation of Semisolids

Pre-validation Requirements : Cleaning Validation Preventive Maintenance for Facilities and Utilities Calibration of Equipment Equipment Qualification Raw Materials/Components/Test Methods Process Justification Documentation Change Control Training operators

Validation Protocol

Validation Protocol should contain: Title Page, Review/Approval Page Purpose and Overview Equipment List Ingredients and Component List Process Flow Diagram and Description Equipment Critical Process Parameter Process Validation Sampling Plan/Testing Requirements Acceptance Criteria Stability Requirements Process for evaluation of any deviations occurring during validation

Critical Processing Steps

Preparing Internal and External Phase

Mixing two phase together

Homogenizing

Final Mixing

Equipment Critical Process Parameter:

Mixing Speed Homogenizing Speed Mixing Time Heating / Cooling Time Pumping Speed (Flow Rate)

Conclusion

• Process must be continually monitored and change • control used to identify need for process revalidation • Validation Protocol identifies critical process • parameters to be evaluated and predetermined • acceptance criteria• Production and QA have to review and approve

the • validation result• Product must be held until the validation get • approval