quality
     
 
  MENOVO has established an independent, strict and sound quality management system in accordance with GMP and ICH Q7A guideline, delivered by the two executive organs QA and QC.
  The Quality control department(QC) is well equipped with state of the art instruments such as, High Pressure Liquid Chromatograpy (HPLC), Gas Chromatography(GC), Ultraviolet Spectroscopy (UV), IR. We cooperate with famous China Institute which can jointly use the below equipment .
--- Polarimeter
--- Adiabatic Calorimeter (RC1)
--- GC-MS / HPLC - MS
--- FT-IR
--- Nuclear magnetic resonance (500 MHz, H,C,N,P)
--- DSC
--- XRPD
  The QC is staffed with a team of qualified professionals, testing and analysis of incoming materials, raw materials, packing materials, intermediates, in process controls of API products,
the Quality Assurance department (QA)With an expert team of professionals on cGMP/GLP, helps realize the maintenance of highest level of compliance with the cGMP/GLP regulations at Menovo manufacturing units . In ensuring the essential importance of product quality and compliance to cGMP in today’s globally competitive pharmaceutical market, Menovo welcomes both customers and government authorities to inspect its facilities.
  The Quality Assurance(QA) plays a frontier role towards the goal of menovo becoming a certified manufacturer by major international regulatory authorities. Menovo is plan to be active member of Responsible Care and holds an ISO 9001 and ISO 14001 certificates as an API manufacturer.
  The Quality Assurance department also brings forward the Quality Policy of the company. The policy portraits the companies approach towards achieving global quality standards.
  Some standard QA activities: Periodic audits of manufacturing facilities to ensure product purity, integrity and safety. Supplier audits/trainings for ensuring the quality of raw materials and compliance of suppliers with cGMP. Training and auditing to assure compliance with cGMP/GLP of new process transfer activities from R&D to scale-up and manufacturing.
  The plant projects unit prepares an annual Validation Master Plan according to which, all calibration, installation qualification, operational qualification, laboratory instruments-IQ/OQ/PQ, analytical method validation, process validation, equipment cleaning validation, HVAC, water and nitrogen validation studies are performed in compliance with cGMP regulations.
 
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