Quality target product profile (QTPP)

slide about QTPP used in ICH guidelines and Formulation and development

1. Quality target product profile By- Priyesh Singh Roll no-19 Alard college of pharmacy,pune.

2. content What is QTPP? Why QTPP? Content of QTPP. Example QTPP components for IR tablet. Example of (QTPP) safety & efficacy Requirements. Summary Reference

3. What is QTPP? Described in ICH Q8 guide (R2) published in 2009 as “ A prospective summary of the quality characteristics of a drug product.” The quality target product profile forms the basis of design for the development of the product. Considerations for the quality target product profile could include: Intended use in clinical setting, route of administration, dosage form, delivery systems; Dosage strength(s); Container closure system ; Drug product quality criteria (e.g., sterility, purity, stability and drug release) appropriate for the intended marketed product.

4. Conti.... Therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics (e.g., dissolution, aerodynamic performance) appropriate to the drug product dosage form being developed ; the Quality Target Product Profile (QTPP) is based on the approach of Quality by Design (QbD ). The QTPP is a product description that summarizes the characteristics expected during the development to respond to the therapeutic drug target. It is established from the elements relating to the active molecule , its identity, purity or stability, highlighted during the early stages of research and development but also from the scientific data studies of pharmaco-toxicology, pharmacokinetics and clinics.

5. Contents of QTPP i t consists of following...... For the active substance, a molecule and the characterization of the impurities is expected. The structure of the drug substance (conformation, molecular weight …). Its physicochemical properties (pH, melting point , solubility, polymorphism …). The results of studies of pharmaco-toxicology in vitro and in vivo. Functional testing, supporting the mechanism of action of the product . Some characteristics of the finished to meet the required efficiency and safety of the drug product are required.

6. Conti.... The composition of the final product. Related to the route of drug administration , specific features can be highlighted. The package is taken into account to ensure product stability and integrity. Criteria to justify the integrity of packaging and storage conditions necessary to ensure the quality of the product. It should be updated following the changes in the manufacturing process.

7. Example QTPP components for IR tablet Dosage Form Route of Administration Strength Weight Pharmacokinetics Identity Assay Impurities Appearance Content Uniformity Residual Solvents Dissolution Friability

8. EXAMPLE OF (QTPP) SAFETY & EFFICACY REQUIREMENTS

9. Significance of QTPP ? The QTPP is an essential document that enables the formalization and tracing the evolution of the knowledge acquired throughout the lifecycle of the drug The QTPP concerns not only the active substance itself, based on the activity of the product, but also the dosage form chosen which allows to bring the product to its therapeutic target with the desired concentration . Formalizes the state of knowledge of the future stage of drug development . QTPP ultimately justify the choice of the dose, the nature of the packaging, the track & the delivery device. To ensure product’s bioavailability necessary for its effectiveness and safety.

10. Summary QTPP is described in ICH Q8 guide (R2) . based on the approach of Quality by Design (QbD ) QTPP is a product description that summarizes the characteristics expected during the development It is established from the elements relating to the active molecule Packaging documentation is also required for QTPP QTPP ultimately justify the choice of the dose, the nature of the packaging, the track and the delivery device. QTPP is an essential document that enables the formalization and tracing the evolution of the knowledge acquired throughout the lifecycle of the drug

11. reference The Quality Target Product Profile by Dr.Anthony M elvin C rasto POSTED ON FEBRUARY 4, 2014 UPDATED ONFEBRUARY 4, 2014. Avail at: amcrasto.wordpress.com/2014/02/04/ qtpp -the-quality-target-product-profile/ ICH guidelines Pharmaceutical development Q8(R2)