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ParamountParamount Inc. Tokyo, Japan

Quality Control & Assurance

Specified, tested, released.

Five production sections under one DRAP GMP certificate, tested batch by batch and released with a Certificate of Analysis.

A quality management system is a web of procedures, policies, resources and objectives with one purpose: every batch meets its specification.

01

Quality management system

Built to the requirements of DRAP and of every market we export to, and certified to ISO 9001:2015, 14001:2015 and 45001:2018.

02

Quality Control

Every batch is tested in our QC laboratory and released with a Certificate of Analysis before it goes to the field.

03

Dedicated cephalosporin section

Only cephalosporins are made in the physically segregated section, with separate air handling and material flows to prevent cross-contamination. Everything else, macrolides and quinolones included, is made in the general section.

04

Quality Assurance

Written procedures alone don’t guarantee practice. QA works on three levels (procedural, behavioural and measurable) so standards hold on the shop floor.

How it works

Three levels of assurance.

  1. 01ProceduralClear, current SOPs for every manufacturing and testing activity.
  2. 02BehaviouralTraining and supervision so procedures become everyday habit.
  3. 03MeasurableTesting, audits and data that prove the standard was met, batch by batch.
QC laboratoryFluid bed dryer, granulationPackaging lineSegregated cephalosporin section

Certified to

  • DRAP GMP

    Good Manufacturing Practice certificate, Government of Pakistan

  • ISO 9001:2015

    Quality management system

  • ISO 14001:2015

    Environmental management system

  • ISO 45001:2018

    Occupational health & safety management

Other departments

Quality questions? Ask the source.

Regulators, auditors and partners can contact our quality team directly for documentation and audit requests.