PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 269

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PHARMACEUTICAL PRODUCT
MANUFACTURING

MARLENE RASCHIATORE

This chapter focuses on the areas of risk that a drug company may encounter
in pharmaceutical manufacturing. The chapter specifically addresses oral solid
and liquid formulations, and uses a case study to illustrate how to apply a risk
management tool to identify and mitigate risks that could affect product quality
and patient safety. The beneficial outcome of this process is that the manufacturer
critically evaluates the operation and from it gains product and process under-
standing. This information can then be used to make more informed decisions
on a day-to-day basis if and when quality issues arise.
All pharmaceutical product manufacturing processes have inherent risks that
can impact the product quality and patient safety of a drug product. Therefore, it is
important to assess the risks in each manufacturing process. The assessment starts
by identifying and understanding the potential risks, then controlling them to an
acceptable level to ensure that the product consistently meets approved quality
standards for patient safety. The use of risk assessment plays an important role
in the following:

• providing a systematic approach to identify potential risks;
• providing measures to mitigate their occurrence;
• increasing awareness of what will happen in the event of a failure;