Defining the Quality Target Product Profile (QTPP) is the foundational step in generic medicine development. QTPP outlines essential qualities ensuring the final product's safety, efficacy, and regulatory compliance, acting as a roadmap for the entire process.
What is QTPP?
QTPP is a summary of key attributes a generic product must possess to match the original branded drug (RLD). It focuses on delivering the same therapeutic benefits, considering factors such as the intended use, patient population, and RLD characteristics.
Key Elements of QTPP:
1. Dosage Form and Strength:
Specifies the type (tablet, capsule) and amount of active ingredient.
Example: A 10 mg immediate-release tablet releases the drug quickly for rapid action.
2. Route of Administration:
Defines how the drug is delivered (oral, injectable, topical).
Example: Oral administration involves swallowing, a convenient route for many patients.
3. Therapeutic Performance:
Ensures the generic performs similarly to the RLD in dissolution and absorption.
Example: Matching the RLD’s dissolution profile guarantees similar therapeutic effects.
4. Release Mechanism:
Describes how the drug is released (immediate, sustained).
Example: Immediate-release within 30 minutes ensures rapid drug availability.
5. Stability Requirements:
Specifies storage conditions and shelf-life to maintain efficacy.
Example: A 24-month stability ensures effectiveness under standard conditions.
6. Bioavailability/Bioequivalence (BA/BE):
Ensures the generic provides the same effect as the RLD.
Example: Bioequivalence studies confirm the generic and RLD have similar absorption rates.
Importance of QTPP in Formulation Development:
- Guides Design Decisions: Helps teams focus on critical formulation aspects and manufacturing processes.
- Facilitates Risk Assessment: Identifies potential quality risks early, allowing proactive management.
- Ensures Regulatory Compliance: Aligns with FDA or EMA standards, simplifying the approval process.
Example:
For a generic Telmisartan-amlodipine tablet, the QTPP defines strength (e.g., 40 mg Telmisartan, 5 mg Amlodipine), dissolution profiles matching the RLD, and stability (e.g., 24-month shelf-life). These ensure therapeutic equivalence and patient safety.
A well-defined QTPP sets a solid foundation, ensuring critical quality attributes (CQAs) are met, leading to a compliant generic product that delivers consistent therapeutic performance.
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Resource Person: Moinuddin syed. Ph.D, PMP
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