Target product quality profile

Quality by design Product validation Critical quality attributes Process parameters Product life cycle Target product quality profile Formulation... 

Bipolar depression case study 3. Target product quality profile for a tablet... 

The target product quality profile (TPQP) provides quantitative descriptions of clinical safety and efficacy that can be utilized to design and optimize a drug product. Because it describes aspects of clinical safety, the TPQP should comprise quantitative targets for attributes that are related to product performance. Examples include stability requirements and release profiles as these attributes are specifically related to the product s performance. It must be noted that the TPQP is not a specification because it may include analyses that are not required for batch release. Effectively, the TPQP serves as the interface between the prod-uct/process and the patient, where performance characteristics of the product relevant to the clinical performance are quantified. Providing the link between the clinical performance and the process is essential in the QbD paradigm because pharmaceutical quality is defined such that risk to the consumer is minimized and the product performance is commensurate with the label. 

Quality Target Product Profile, CQA definition, and Initial RA... 

Target Product Profile and Critical Quality Attribute The target drug profile consists of prospective and dynamic summary of the characteristics of a drug that should be achieved in order to reproducibly deliver the therapeutic benefit the target product profile (TPP) sets an important number of performance parameters that will be the... 

Target Product Profile and Critical Quality Attributes... 

As introduced in Sect. 8.2.1, the roadmap of any QbD approach starts with the Target Product Proflle (TPP) definition this summary of drug characteristics (e.g., pharmacokinetic properties and stability) will serve as the basis for a set of performance parameters (e.g., immediate release drug 80 % in < 30 min, 36-month shelf life at room temperature, respectively) that, in turn, will be linked to a set of Critical Quality Attributes (CQAs e.g., shelf life will depend on the amount of residual solvents due to its impact on chemical stability release profile will depend on particle size for some drugs due to its impact on dissolution). 

From a natural products standardization perspective, the HPLC profiles of three different batches of Nicosan are illustrated in Figure 3. Here, the HPLC patterns of the three batches are nearly identical as needed. The presence and/or absence and relative ratio and total content of selected targeted compounds are used in the standardization and quality control process. Some of the compounds present in the extract have been identified and are discussed more below. 

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