Quality and Regulatory
All ICROM production units work under cGMP and are regularly inspected by the Italian regulatory Agency (AIFA). ICROM is also approved by the USFDA, Japanese PMDA, Korean FDA and holds Drug Master Files registered and approved in all the main regulated Countries worldwide.
ICROM is compliant with GDUFA regulation.
500 sqm DEDICATED TO
QUALITY CONTROL AND QUALITY
ASSURANCE ACTIVITIES
The brand new Quality Control Laboratory is equipped with the most modern instruments for chemical and physical testing including HPLC, GC, GC-HS, DSC and Malvern Mastersizer
Our Quality Management System is in place to guarantee full compliance to GMP, as described in the ICHQ7 guidelines and Eudralex, Vol. 4.
Our Quality Assurance (QA) and Quality Control (QC) departments are responsible for ensuring that all Pharmaceutical Active Ingredients are manufactured in accordance with relevant procedures, requirements and specifications, in line with cGMP guidelines and client’s quality agreements.
QbD and process controls developed to transfer Quality to Operations.
Continuos training is performed to our employees in order to develop a strong compliance mindset able to guarantee adherence to pharma regulations.
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