The Quality Target Product Profile (QTPP) guides companies for drug development and regulatory decisions. ICH Q8 states that the QTPP is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy.
The QTPP outlines quality characteristics and performance parameters for development, aiding regulatory approval processes. One of the key functions of the QTPP is to define critical quality attributes (CQAs).
Clear QTPP specifications enable appropriate manufacturing processes and risk management, minimizing failures, recalls, and ensuring patient safety. Regulatory authorities rely on the QTPP to assess the adequacy of a drug’s development, manufacturing, and control strategies. Failure to meet the defined QTPP specifications may lead to regulatory non-compliance and delays in market approval.
The QTPP influences post-approval activities, guiding testing methods and acceptance criteria. Changes to QTPP require regulatory approval, triggering necessary actions and variations. Also, the QTPP facilitates flexibility during the product lifecycle, supporting continuous improvement and regulatory harmonization.
The QTPP plays a vital role in pharmaceutical development, ensuring quality assurance and regulatory compliance throughout the product lifecycle.
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