The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified.
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The development of the somewhat recently implemented USP General Chapter <790>, Visual Inspections in Injections, was undertaken to address this gap in information. Information Chapter USP <1790>, Visible Particulates and Injections, was also prepared to provide further guidance in this area .
It is important to remember that USP General Chapters, those with numbers below 1000 (USP<790>) are enforceable by the FDA and compliance is expected. Informational USP chapters, with numbers of 1000 and above (USP <1790>), are meant as guidance and are written to support successful implementation of the General Chapters.
Despite these new USP Chapters, there is still confusion in the industry concerning the requirements of Visual Inspection and the implementation of an inspection system compliant with USP <790>.
In a 2014 publication and seminars, John Shabushnig, PhD, one of the leaders of the committee that wrote the new USP Chapters on Visual Inspection, highlighted the intent and changes in USP <790> and <1790>.
“The intent of USP General Chapter <790> was to move towards a global standard to define what is visible by defining a common set of inspection conditions:
- An inspection light intensity of 2000 to 3750 LUX
- Inspection for five seconds against black and white backgrounds
- The container should be swirled or inverted during the inspection provided that this does not damage the product.
- No magnification requirement is specified
- The inspection processes applies to extrinsic (coming from outside of the process) and intrinsic (coming from processing equipment and the primary packaging).
- In the special case of inherent particles, such as protein agglomerates, individual monographs may need to be developed and included and approved in the regulatory filing for the product.
- Defines the use of accepting sampling for batch release, after 100% inspection, using a General Level II sampling plan from ANSI/ASQ Z1 .4 standard with an AQL of 0.65%. ISO 2859 also provides an equivalent sampling plan. “
To support the implementation of USP <790>, the USP Information Chapter <1790> Visible Particulates and Injections was written. The scope of USP <1790> includes manual inspection but also extends to other visible defects such as container integrity and other inspection methods such as semi – automated and automated systems. USP <1790> provides the following information:
- Introduces the concept of the inspection lifecycle to help identify types of particulates and their source with the goal of continuous improvement and reduction in particulates throughout the process.
- Provides more detailed discussion on the risk of particulates to patients to aid in risk assessments.
- Provides recommendations and methods for the proper preparation of test sets to assess manual inspection performance and to qualify inspectors. These procedures may be applied to the qualification and validation of semi–automated and automated inspection processes.
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