Manufacturing and QC of Semi-solids

What is a Critical Process Parameters

Critical Process Parameters are process parameters whose variability has a direct impact on the critical quality attributes of a product

What is critical quality attributes and process parameters

Critical quality attributes are the physical , chemical, biological or microbiological properties that must be within an appropriate limit to ensure product quality

Process parameters: Conditions like temperature, ph, mixing speed, pressure during manufacturing

What are the properties that needs to be considered in the packaging of semi-solid

Compatibilit- packaging material must not react with the product

Barrier Properties: Product from moisture, oxygen, light

Ease of use: Patient-friendly dispensing

Sterility: For products like ophthalmic gels or medicated creams

Storage conditions: temperature, humidity sensitivity

What are semi solds packaged in

Syringes/Applicators

Bottles with pumps

What’s the difference between quality assurance and quality control

Quality assurance is a proactive, process-oriented approach aimed at preventing defects by ensuring proper procedures and systems are in place

Ensure the process produces a product that meets quality standards consistently

Quality control is a product-oriented approach aimed aimed at detecting defects in finished products through testing and inspection

Ensure the product meets predefined specifications before release

What is stability testing

Commercial manufacture and packaging, jars and tubes are

first tested for compatibility and stability of the intended

product

• Samples removed from a minimum of 3 independently

manufactured batches and placed on stability under 2

conditions