Is your organization compliant with USP chapter <790>, which requires injectable drugs to be essentially free of particulates? Do you visually inspect each sterile injectable after it has been compounded under suitable and controlled conditions?

The presence of foreign particulate matter in injectable parenteral drugs is one of the most common reasons for recalls in the pharmaceutical industry. As the FDA begins to inspect more and more pharmacies and hospitals, observations are being issued regarding inadequate visual inspection procedures. State Boards of Pharmacy are beginning to notice this trend and are also expecting more from compounders. This eBook dives into the nuances of manual visible particle detection methods and how to become compliant with USP <790>, Visible Particulates in Injections.

After reading this eBook, you will be able to:

1. Discuss regulatory expectations of visual inspection of parenteral drug products.

2. Select and qualify the equipment used in the manual visual inspection of compounded drug products.

3. Qualify or assist with qualifying personnel to conduct manual visual inspections.

4. Assess the importance of using a validated inspection test kit that reflects the inspection of the types of products you compound.

5. Conduct a manual visual inspection of parenteral drug products and compounds using best practice procedures.

6. Discuss common statistical methods to determine the acceptance criteria needed to pass a visual inspection and be able to recognize when to perform a re-inspection.