Visual Inspection of Medicinal Products for Parenteral Use
1 Scope
This paper aims to highlight best practices for carrying out 100 % visual inspection of medicinal products for parenteral use in the pharmaceutical industry. It should be seen in addition and complementary to the monographs of 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 particulate matter and/or turbidity, and correct or uniform appearance of a lyo cake.
Modifications of procedures and figures proposed in this paper are possible at any time. However, following the proposed procedures and figures may lead to safer inspection processes and may avoiddiscussions in GMP audits and inspections, as the described approach reflects current practice and has shown its suitability during many years of industrial operation and GMP inspections.
The CCI (Container Closure Integrity) topic is out of scope of this paper (see ECA position paper “Container Closure Integrity testing of medicinal products for parenteral use”).
