The visual inspection process is a critical
step in the reliable supply of high-quality
injectable medicines. It is required by
regulatory authorities and specified in
various international pharmacopeias. This
important step also provides information on process performance and informs
where and how to improve the manufacturing process.
Yet there continue to
be challenges in this area as evidenced
by persistent drug product recalls due
to particulate matter. In addition, in the
first few months of this year, the US FDA
released two
Warning Letters on visual
inspection issues.
For many years, the requirements for visual
inspection have been ambiguous, with little
direct guidance on how to inspect and what
acceptance criteria to apply to the inspection
process. This has resulted in a wide range of
inspection practices as evidenced by a PDA
survey on visual inspection conducted in 2014. This situation has improved with the
release of USP <790>
Visible Particulates in
Injections
in August 2014 and USP <1790>
Visual Inspection of Injections
in March 2017 (1).
PDA is also completing a technical
report to provide guidance on difficult-to-
inspect products, such as lyophilized powders, strongly colored solutions, and those
packaged in amber containers.
Since 2000, PDA has held the
Visual
Inspection Forum
each year to discuss new
technical and regulatory developments in
this field. It alternates between the United
States and Europe; this year’s meeting will
be held in Bethesda, Md. The meeting
provides a forum to present and discuss
new developments in the field of visual inspection, including a basic understanding
of the sampling and inspection process,
special aspects of biotech products, the
identification, risk assessment, and control
of particles, and the contribution of packaging materials to these observed particles.
This is an excellent opportunity to learn
more about visual inspection and to discuss inspection challenges with colleagues
and experts.
Reference
- U.S. Pharmacopeia. General Chapters. USP39–
NF34. Rockville, MD : 2016.
Learn more about the 2017 PDA Visual Inspection Forum and related PDA Education courses.
