Yes, sterility is a critical quality attribute (CQA).
Sterility, meaning the absence of viable microorganisms, is a paramount quality characteristic for many pharmaceutical products, particularly injectables, implantable devices, and other items that come into contact with sterile tissues. The provided references repeatedly highlight sterility as a key CQA. For instance, one reference explicitly lists "sterility, purity, stability, and drug release" as examples of drug product quality criteria, with sterility clearly identified as a CQA. Another states that "common CQA categories include safety, identity, sterility, purity and potency." Furthermore, several articles discuss sterility testing and its role in assuring the quality of sterile medicinal products. The importance of sterility in achieving the desired quality of a product makes it a critical quality attribute.
Several references emphasize the importance of sterility in the context of:
- Sterile pharmaceutical products: The absence of viable microorganisms is non-negotiable for injectables and other sterile applications.
- Aseptic processing: Sterility assurance is a critical aspect of aseptic manufacturing processes.
- Regulatory compliance: Regulatory bodies (like the FDA) strictly mandate sterility testing and validation for sterile products.
Therefore, maintaining sterility is crucial and directly impacts the safety and efficacy of these products, solidifying its status as a critical quality attribute.
