Quality Policy
SHE Policy
Company Objectives
The principle of Total Quality Management is a way of life at Calyx.
Calyx Quality Policy ensures basic values are instill in our employees and quality inbuilt in our products.. Our SHE Policy expresses our commitment towards safety, health and environment.
Management Systems
ISO 9001: Quality management system:
Providing framework for:
  • Business operating system
  • Integration of manufacturing & other business processes
  • Customer satisfaction
  • Supplier evaluation
  • Continual improvements of processes
  • Corrective actions & preventive actions (CAPA)
  • Operational improvement plans
ISO 14001: Environmental management system
It focuses on achieving and demonstrating sound environmental performance by:
  • Identifying all activities, products & services having direct or potential impact on
    environment.
  • Deciding those having significant impact.
  • Adequate operational controls on significant environmental aspects.
  • Periodic evaluation of compliance to applicable statutory and legal requirements
  • Effective environmental communication including to external interested parties.
  • Emergency response & preparedness.
Quality Assurance:
Comprehensive
  • Standard Operating Procedures (SOP’s)
  • Quality Control Specifications and test methods
  • Batch Manufacturing Records
  • Internal audits
  • cGMP and Job oriented training and evaluation
  • Validation of Equipments, Process, Analytical Methods & Cleaning
  • Effective Document Control
Quality Control:
Quality control facilities having latest analytical tools
  • Wet chemistry laboratory
  • Instrumentation rooms equipped with IR, UV. GC, HPLC, TOC
    analyser, environmental ovens for stability testing
  • Microbiology laboratory
Regulatory Affairs
Calyx regulatory cell has competence in filing DMF/CTD/COS and has proven capabilities current
filing. Calyx facilities are constantly upgraded to comply with European, US and other
international regulatory bodies to ensure regulated market share.
DMF filings planned:
  • Artementher
  • Artesunate
  • Azithromycin
  • Cetirizine hydrochloride
  • Clarithromycin
  • Desvenlafaxine
  • Eszopiclone
  • Hydroxyzine hydrochloride
  • Irbesartan
  • Isoniazid (New Process)
  • Losartan Potassium
  • Lumefantrine
  • Meclizine hydrochloride
  • Piperaquin
  • Telmisartan