Quality Control

To achieve the organization’s goal, the Quality Control (QC) Department works with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), data integrity, Good Documentation Practice (GDP), 5S and good safety procedures.  We give importance to personnel competence, impartiality, consistent operation, right first time and established good quality culture. 

Additionally, the implementation of the ISO 9001:2015 Quality Management System is the highest priority.

Following quality management principles gives us good instruction for operating departmental functions-

  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-, based decision making
  • Relationship management
Target goals of the Quality Control Department-

For robust monitoring & control, maximum productivity and good service to its interested parties, the Quality Control Department has divided the following sections –

    1. Analytical Science & Technology (AST)
    2. Supplier Approval & Control
    3. Packaging Materials
    4. Raw Materials
    5. Finished Goods
    6. On-going Stability
    7. International Business Development- IBD ( Documentation)

Quality control department is engaged with the following processes –

    1. Packaging materials, production stationary & promotional items sampling, testing, release & labeling.
    2. API, excipients, cleaning agent, sanitizing agent and engineering chemical sampling, testing, release & labeling.
    3. Intermediate, bulk and finished product testing and reporting.
    4. Water testing and system monitoring.
    5. On-going stability study
    6. Supplier approval & control
    7. Supplier complaint management
    8. Internal documentation (SOP, Specification, Analytical method, Analytical worksheet, Logbook, raw data, audit trial data, reporting, archiving, backup, recording, trend analysis, etc.).
    9. Sample Management (Test sample, retention sample, stability study sample, source evaluation sample).
    10. Analytical method development & validation.
    11. Cleaning validation.
    12. People development (Analyst validation).
    13. Equipment purchase, qualification, calibration and maintenance.
    14. Primary and secondary reference standard management (Purchase, checking, preparation, storage & issue).
    15. Reagent and auxiliary items management ( Purchase, checking, storage & issue)
    16. Laboratory waste management
    17. Specification & analytical method ( Packaging, Raw & Finished )
    18. Solution preparation ( TS, VS, Indicator, Buffer Solution )
    19. Laboratory compliance management (CAPA, CC, Deviation, Lab Incident, Investigation, OOS, Data trending, Risk assessment, Audit, Data integrity Issue).

A modern and well-equipped QC laboratory has been set up for the pharma division. It ensures quality, safety, purity & efficacy of starting materials and verifies the quality of manufactured products considering quality, safety & efficacy.

It has a dedicated IBD section (Documentation) to give support for registering the products in overseas markets such as the United States of America, Venezuela, Guatemala, Myanmar, Sri Lanka, Cambodia, Vietnam, Laos, Kenya, Somalia, Afghanistan, Yemen, Mali, Bhutan, Georgia, Ghana, Mauritius, Senegal, Uganda and Zimbabwe.