Hello.
Am I right in thinking that “Clarity” is a mandatory control parameter for injections (sterile liquid parenteral preparations), and this parameter cannot be omitted from the specification or replaced with another parameter?
I would like to ask you to share your experience in determining the clarity of highly colored injections (sterile liquid parenteral preparations): which approaches (methods, devices) are effective and which are ineffective?
Hello Lex, and welcome.
There is no regulatory expectation that ALL parenteral solutions have to be “clear”. Current regulatory expectation is that all prdocut Critical Quality Attributes (CQA) come from a risk based approach (e.g. QbD as per ICH Q8). Thus, only if the solution’s “clarity” is determined as a CQA, then it should be within a defined value or range.
I think that the most probable situation is that you understood clarity in a sense where the regulatory expectation is that 100% of parenteral solutions must be visually inspected for particles and other defects. The clarity of the solution is a characteristic that is aimed for, if possible, because it allows for an effective visual inspection of the product.
But even then, some parenterals like emulsions or opaque solutions do not have this “clarity” so guidelines like the ones stated un USP 1790 help to determine methodologies and approach to inspect these “difficult to inspect parenterals (DIP)” to ensure product is essentially free of particles.
So, the answer is no, not all parenterals need to be “clear” but must be free of any type of contamination. Clarity helps to inspect for presence of contamination. Clarity would be a mandatory specifications if justified through QRM and QbD approach.
I hope this helps.