Quality Management System (QMS)


The Quality unit in HPL is as per WHO guideline, consists of Quality Assurance and Quality Council, which are working independently. The Quality Assurance department consists of Quality Control and Quality Compliance (Quality Assurance). Quality assurance and Quality Council are a wide ranging of concept which covers all matters individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors relevant to quality assurance and Quality Council is confirming the consistency of quality improvement at site. The system of Quality Assurance and Quality Council appropriate for the manufacture of medicinal products:

  • Medicinal products are designed and developed in a way that takes account of the requirements of GXP.
  • Production and control operation are clearly specified and Good Manufacturing Practice adopted;
  • Arrangements are made for the manufacturer, supply and use of the correct starting and packaging materials;
  • All necessary controls on intermediate products, and any other in-process controls and validations are carried out;
  • Medicinal products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorization and any other regulations relevant to the production, control and release of medicinal products;
  • There is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance System.
    • Quality Control is responsible for testing and analysis drug substance, excipients, dosages forms and packaging materials. Reagents Management of QC Laboratory, Management of Retention sample, Reference Standard Management, preparation of testing instruction and batch release.
    • Quality Compliance is responsible for Change Control Management, deviation control, handling of product complaint, product recall handling, Product quality review, documentation management.
    • Quality Assurance is responsible for Self Inspection, Policy preparation, Gap analysis, Validation, Personnel Training, Qualification, Ensure Data Integrity onsite and also confirms quality system as per regulatory requirement.
    • Quality Council is responsible for review and evaluation of quality performance indicator, progress review and self-monitoring of Quality CAPAs, Quality Projects.