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In this stage all production processes and manufacturing equipment is proofed to confirm quality and output capabilities. Critical quality attributes are evaluated, and critical process parameters taken into account, to confirm product quality. Once the process qualification stage has been successfully accomplished, production can begin.
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process. CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes. Those attributes with a higher impact on CQAs should be ...
This was critical for the industry due to the sensitivity of drug substances, biologics and vaccines to various temperature conditions. The FDA has also been very focused on this final area of distribution and the potential for a drug substances quality to be impacted by extreme temperature exposure. 4.6.
It involves defining the Critical Process Parameters (CPPs) of the equipment used to make the product, which affect the Critical Quality Attributes (CQAs) of the product and then controlling these CPPs within defined limits. This allows manufacturers to produce products with consistent quality and also helps to reduce waste & overall costs.
Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [1] This may include testing equipment at maximum operating capacity to show quantity demands can be met. [2]
There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets.
Critical to quality is an attribute of a part, assembly, sub-assembly, product, or process that is literally critical to quality or more precisely, has a direct and significant impact on its actual or perceived quality. [1]
The identification of all possible critical quality attributes (CQAs) underpin effective QA. Microfluidic modulation spectroscopy facilitates the measurement of secondary structure attributes of biopharmaceuticals in all stages of the manufacturing process. This helps establish quality parameters at stages not possible with traditional techniques.
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