OUR QUALITY ASSURANCE

At NxGen Wholesaling our number one priority is the quality of our Active Pharmaceutical Ingredients (APIs). It is for this reason that we turn to MEDISCA. MEDISCA is an FDA registered establishment in compliance with the current Good Manufacturing Processes (cGMPs).  Testing APIs is vital to the quality system and compliance with cGMP.

We make sure that we can trace the full pedigree of any API we supply at NxGen Wholesaling. MEDISCA qualifies all manufacturers by their Vendor Qualification Program. Full compendial testing is performed on the first lot of any API received from a new manufacturer. All subsequent lots will undergo partial testing, including an identification test.  In order to maintain quality products, MEDISCA purchases APIs from USFDA registered manufacturers.

Compendial testing is performed by 3rd party testing laboratories that are FDA registered. These testing laboratories are qualified by MEDISCA biennially to assure the cGMPs and cGLPs are being followed and meet MEDISCA’s standard. MEDISCA also perform in house testing which includes identification and melting point determination.

In 2010 MEDISCA’s facility has successfully obtained Verified Accredited Wholesale Distributor (VAWD) Accreditation. This accreditation confirmed that MEDISCA successfully underwent a criteria compliance assessment, which included a rigorous review of the operating policies and procedures, a thorough facility audit, background check and screening inspections

Every compounder needs to ask themselves if their products are subjected to the same ruthless testing that can be said for the full range of MEDISCA APIs. If not then you must then ask yourself ‘is it worth the risk?