Quality Policy
SHE Policy
Company Objectives
The principle of Total Quality Management is a way of life at Calyx.
Calyx Quality Policy ensures Quality basic values are instill in our employees and inbuilt in our products.
Our SHE Policy expresses our commitment towards safety, health and environment.
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.
CTD filings planned:
  • Alendronate Sodium
  • Venlafaxine HCl
  • Lisinopril
  • Erythromycin Stearate
  • Erythromycin Base
  • Erythromycin Ethyl Succinate
  • Erythromycin Estolate
  • Rosiglitazone
  • Pioglitazone
  • Carvedilol
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.
  • Controlled by stringent monitoring or using environmental management programmes.
  • Periodic evaluation of compliance to applicable legal requirements
  • Effective environmental communication including to external interested parties.
  • Emergency response & preparedness and
  • Adequate operational controls on significant environmental aspects.

ISO 14001 provides a framework for managing environmental responsibilities so that they become more
efficient and more integrated into overall business operations.