Article Regulatory 2015 Best Practice Paper Visual Inspection Vs 1.0
Article Regulatory 2015 Best Practice Paper Visual Inspection Vs 1.0
Article Regulatory 2015 Best Practice Paper Visual Inspection Vs 1.0
Visual Inspection of
Medicinal Products
for Parenteral Use
Version 1.0
(September 2014)
This ECA Good Practice Paper was developed by the Steering Committee oft he
ECA Visual Inspection Working Group
Authors
Review
Non-liability: While every effort has been made to assure the accuracy oft he
content, Concept Heidelberg or the ECA Foundation cannot be held liable for
any errors or omissions
This paper aims to highlight best practice for carrying out visual
inspection of medicinal products for parenteral use in the
pharmaceutical industry. It should be seen as additional to and
complimentary with the different Pharmacopoeias. Visual inspection of
medicinal products for parenteral use should detect any readily
identifiable visible container defect and ensure constant quality of the
product in terms of absence of particular matter and/or turbidity, correct
or uniform appearance of a lyo cake.
Deviations from the herein proposed procedures and figures are possible
any time. But sticking to the proposed procedures and figures may lead
to safer inspection processes and less discussions in GMP inspections, as
the described approach has shown its suitability during many years of
industrial operation and GMP inspections.
2. Manual inspection
2.1 Workplace
The premises where the manual visual inspection takes place
should be suitable for carrying out this operation. Besides the
common GMP requirements for manufacturing or quality control
areas, of substantial importance for suitable inspections conditions
are:
Illumination:
The intensity of the illumination at the inspection point should
have at least 2000 lux. For Blow-Fill-Seal Products an illumination
of 10.000 lux is recommended. The total uncertainty of the lux-
meter should be considered. The color reproduction n, using the
CRI index, should have an RA value > 90% and not less then 80%.
Ambient conditions:
The ambient conditions are of enormous importance for carrying
out this operation. Temperature should be ambient and should not
exceed 25 °C in the summer if not otherwise justified. The relative
humidity and air velocity should be controlled and ensure
comfortable working conditions. The noise level should therefore
be below 55dB.
2.2 Personnel
Personnel involved in the visual inspection should regularly
undergo an eye test. The optometrist should focus on the ability to
discriminate small differences in uniform structures, e.g.
open/closed circles.
The post inspection recovery time for the employees carrying out
the Visual Inspection is of essential importance. The maximum
time for continuous inspection activity between break periods and
the total maximum inspection time for a shift/workday must be
limited.
3. Automated inspection
3.3 Requalification
Requalification of an automated inspection system should be
ideally carried out annually, or every two years at the latest. This
must be done by evaluation of the changes and deviations that
occurred during the period of operation. This review must include
a statistical trend analysis of the performance data obtained during
routine inspection and system suitability determinations using the
function sets before and after every machine use.
3.4 Revalidation
An automated visual inspection machine should be seen
as a critical system. Therefore a periodic revalidation
should be carried out, e.g. ever 3-5 years. Revalidation (as
validation) is product specific. Bracketing approaches for
the revalidation are possible.
Independent from the approach used, the result and its evaluation
should be documented in a revalidation report.
4. Defect Classes
Major defects: may alter the content or the function of the product
NOTE:
“Grey Channel” for fully automated inspection systems: The usage
of a “grey eject channel” in automated inspection may be useful
for containers for which the inspection result is not clear. On a
technical point of view a grey channel is also meaningful due to
e.g. machine stops, when it is uncertain whether a vial has been
fully inspected or not.
Critical: 0
Major: AQL 0.65 or 1
Minor: AQL 4 to 6.5
AQL
Acceptable Quality Limit, using ANSI/ASQ Z1.4 or ISO 2859-1,
general inspection level II
CRI-Index:
The Color Rendering Index (CRI) is a unit of measure that
defines how well colors are rendered by different illumination
conditions in comparison to an ideal or natural light source. The
Ra value uses only the first eight from the 14 test colors of the
DIN 6169. Light sources have different Ra values, e.g. a white
LED 80-95; fluorescent lamps 50-90.
Function set:
A function test kit (system suitability test kit) used before and
after the inspection of each batch to demonstrate the
functionality of the fully automated inspection system. It may
contain an abridged set of more crude defects such as big
particles, cracked or empty containers.
Particle:
A particle in this context means a readily visible particle with a
diameter or span of 150 µm or bigger. Smaller, for example
colored particles may be visible down to a size of 50 µm or
smaller. These particles have also to be counted to the visible
particles.
Training set:
A test set used for the training of the operators of the manual
inspection, to teach the possible defects. Similar to the
qualification set but contains only containers with defects.
Visual Inspection:
The process of sorting unacceptable units from acceptable units
by human visual inspectors and/or through qualified
equipment.