Quality Assurance

This department focuses on:

  • Allchem laboratories establish, document, and implement an effective system for supervising quality control. To establish and maintain the quality management system, the active participation of control supervisors and appropriate Allchem laboratories staffs are involved.
  • The components of the quality management system is encompass the activities necessary for manufacturing control and quality control of finish product as well as organizations and other required sources to implement the activities. In established the quality management system, all quality- related activities are defined and documented.
  • The quality unit, independent of production unit. All quality-related activities are recorded at the time are performed.
  • Any deviation from established procedures are documented and explained. As to critical deviation for which the effect on product of quality cannot be denied, the quality unit is confirm the results of evaluation and necessary action by the decision of release from the Allchem laboratories.
  • The quality unit is involved in all quality-related matters; reviews confirm and approve all appropriate quality-related documents.

The main responsibilities are described in writing and are included but not necessarily are limited to:

  • Handling of customer complains forwarded by the marketing department & their investigations.
  • Handling and review of deviation, change control proposal.
  • Responsible for approval and rejection of finished products.
  • Responsible for review of APQR.
  • Responsible for preparation and checking of SOP’s.
  • Responsible for organizing training program.
  • Responsible for ensuring that all activities carried out in site in compliance with cGMP/ cGLP.
  • Review of Qualification document.
  • Responsible for Internal/Audit/Self Inspection are performed as per defined schedule.
  • Responsible for approved vendors list up dation and vendor assessment.
  • Responsible to ensure effective system for calibration of critical equipments is in place.
  • Responsible for approval of CAPA.