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  • Describe the types of safety and efficacy risks that may occur after taking a drug product and various means for preventing these risks.

  • Differentiate between drug product quality and drug product performance.

  • Differentiate between quality control and quality assurance.

  • Explain how quality by design (QbD) ensures the development and manufacture of a drug product that will deliver consistent performance.

  • Define quality target product profile (QTPP) and explain how QTPP is different than conventional quality product criteria.

  • Identify various formulation and manufacturing process factors that affect product quality and performance and the concept of QTPP.

  • Describe the quality principles underlying basis for the development, manufacture, and quality assurance of the drug product throughout its life cycle in QbD.

  • Describe how product specifications relate to drug product quality and the relevance to quality assurance of the drug product through QbD.

  • Describe a practical strategy to track risks in a drug product development by drawing a scientific roadmap for validating the overall process of material acquiring, manufacturing, and distributional steps involved in a drug product appropriately labeled for medical use.

  • Define critical quality attributes and how these attributes relate to clinical safety and efficacy.

  • Explain how postapproval changes in a drug product may affect drug quality and performance.

  • List the major reasons that a drug product might be recalled due to quality defects.


Side effects from the use of drugs are the major cause of drug-related injuries, adverse events, and deaths. The FDA (FDA, CDER, 2005, 2007) has summarized various types of safety and efficacy risks from medicines (Fig. 18-1). Side effects are observed in clinical trials or postmarketing surveillance and result in listing of adverse events in the drug’s labeling. Some side effects are avoidable, and others are unavoidable. Avoidable side effects may include known drug–drug or drug–food interactions, contraindications, improper compliance, etc. In many cases, drug therapy requires an individualized drug treatment plan and careful patient monitoring. Known side effects occur with the best medical practice and even when the drug is used appropriately. Examples include nausea from antibiotics or bone marrow suppression from chemotherapy. Medication errors include wrong drug, wrong dose, or incorrect drug administration. Some side effects are unavoidable. These uncertainties include unexpected adverse events, side effects due to long-term therapy, and unstudied uses and unstudied populations. For example, a rare adverse event occurring in fewer than 1 in 10,000 persons would not be identified in normal premarket testing. Chapters 13, 21, and 22 discuss how pharmacogenetics, pharmacokinetics, pharmacodynamics, and clinical considerations may improve drug efficacy and safety in many instances. Drug product quality is another important consideration. Quality is recognized and defined in ICH (International Conference on Harmonisation,1 which provides for international standards of new drug product quality; see below) as the suitability of either a drug substance (Chapter 17) or drug product for its intended use. This term includes ...

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