Quality Risk Management:

 Quality Risk Management:

A systematic process for the assessment, control, communication and review of risks to the quality of the drug products across the product lifecycle (ICH Q9).

Quality Target Product Profile (QTPP);

A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, safety and efficacy of the drug product.

Reference Listed Drug (RLD),

RLD is an approved drug product to which new generic versions are compared to show that they are bioequivalent.

Rheology:

is the study of the flow of matter, primarily in a liquid state. It describes the interrelation between force, deformation and time.

Robustness:

refer to the ability of an analytical method to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

State of Control:

A condition in which the set of controls consistently provides assurance of continued process performance and product quality (ICH Q10).

The Center for Drug Evaluation and Research (CDER);

performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

Therapeutic Equivalence (TE):

Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.

TOC:

Total organic carbon (TOC) is a measure of the total amount is of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment.

Validation:

is the method of analysis or process performance checking to ensure the operational activity is correctly performed.

Viscosity;

The measurement of a materials resistance to flow. Viscosity can determine using a viscometer.

Zeta Potential:

is defined as the potential difference between the dispersion medium and the stationary layer of fluid attached to the dispersed particle. The significance of zeta potential is that its value can be related to the stability of colloidal dispersions (e.g., a multivitamin syrup).