Quality target product profile (QTPP)
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The document discusses the Quality Target Product Profile (QTPP), which describes the quality characteristics of a drug product. The QTPP is established early in development based on factors like intended use, dosage form, and safety/efficacy requirements. It serves as the basis for product design and helps justify choices around dosage, packaging, and delivery. The QTPP should be updated as development progresses and knowledge about the product evolves. Key components of a QTPP include details on the active substance, finished product specifications, and packaging documentation.
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The document discusses key concepts of Pharmaceutical Quality by Design (QbD), including defining a quality target product profile, identifying critical quality attributes, understanding the product and manufacturing process through tools like risk assessment and design of experiments, establishing a design space and control strategy, and enabling continual improvement. The goals of QbD are to enhance robustness and control of the manufacturing process to reliably deliver the desired product quality and performance.
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The document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses key QbD concepts like defining a quality target product profile, identifying critical quality attributes and critical material attributes, designing quality into the product through development strategies like design of experiments, and establishing a design space and control strategy. The document outlines the important steps and aspects of a QbD-based pharmaceutical development process from formulation to manufacturing. It emphasizes gaining process understanding, building quality into the product, and taking a systematic risk-based approach.
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Quality target product profile (QTPP)
- 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 th e 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 it 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 en sure 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 evo lution 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 p roduct, but also the dosage form chosen which allows to bring the product to its thera peutic 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 du ring 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 trac k and the delivery device. – QTPP is an essential document that enables the formalization and tracing the evolu tion of the knowledge acquired throughout the lifecycle of the drug
- 11. reference – The Quality Target Product Profile by Dr.Anthony Melvin Crasto POSTED ON FEB RUARY 4, 2014 UPDATED ONFEBRUARY 4, 2014. Avail at: amcrasto.wordpress.co m/2014/02/04/qtpp-the-quality-target-product-profile/ – ICH guidelines Pharmaceutical development Q8(R2)