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Definition of GMP Requirements for a New Aseptic Ointment Filling Line




Montreal area (Quebec), Canada


Qualification and validation


As part of its plan to upgrade its manufacturing facilities, our client wished to acquire a new aseptic ointment tube filling and packaging line to replace its existing line reaching the end of its useful life.


Genipro was commissioned to draft the User Requirement Specification (URS) documents associated with the aseptic ointment tube filler; the in-line checkweigher; and the cartoner. The URS writing process served to identify the company’s needs while complying with pharmaceutical GMP regulatory requirements.


The main challenge for our team was to understand the specificity of the client's current process for manufacturing ointments in an aseptic environment. Producing in such an environment imposes numerous constraints. We therefore had to ensure that this new production line, made up of a filler, an online checkweigher and a cartoner, complied with all the requirements.
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