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Why Quality is Important in Pharmaceuticals?

A measure of excellence or a state of being free from defects, deficiencies and significant variations.

Quality Assurance

Obtaining confidence that, required quality of product or service is satisfactory for their intended use.

Quality Control

Part of GMP concerned with sampling, testing and specifications.

Organizational Structure

Assures that Quality is independent and not subordinate to other organizational unit.

Quality Culture

Assures that Quality is independent and not subordinate to other organizational unit.

  • Support for the Quality Organization
  • Actions More than Words
  • Investment in Quality
  • Quality Involved in Relevant Business Decisions
  • The Quality of the Work You Accept Becomes the Organization’s Standard

Quality Responsibility

  • Quality is the collective responsibility of every individual in an organization.
  • Quality must be designed into a Product.
  • Product quality criteria must be established.
  • Detailed specifications provide quantitative parameters for measurement.
  • Written procedures document how quality is attained and maintained.
  • Continuous monitoring (sampling, testing) to confirm quality is being built-into product.

Quality Responsibility

To Ensure :

  • Raw materials used in the manufacturing are approved and procured from approved vendor.
  • All datas are recorded as per ISO, GMP & WHO and is reviewed for accuracy and traceability.
  • Procedures are in place for performing the activities, operating and calibrating the equipment.
  • Quality is built up in the plant, process and product. That a Robust Quality system is in place.
  • Trainings like induction, On job, Scheduled and after any changes are conducted to respective individuals on time.
  • To prepare and approve Quality Policy, Quality Objectives, Quality Manual and Validation Master Plan.
  • Periodic Monitoring of the Quality Objectives.
  • Monitors all validation & stability activities are completed as per the schedule.
  • Ensures that all changes impacting the product and the established systems are documented and reviewed to analyze the impact.
  • Ensures that all deviations, OOS/OOT & Market complaints are logged, investigated to identify the root cause so as to take CAPA to prevent recurrence.
  • Preparation of Annual product quality reports, trending of data, determining product and process performance.
  • To arrange and conduct the self inspection, identify gaps and take CAPA.
  • Review of related batch manufacturing records and QC testing data Prior to release of any batch.

Quality Metrics

A tool for continuous improvement in Quality.

It is a measurement standard by which efficiency, performance, progress compliance or quality of a process, or product can be assessed.

  • KPI’s shall be identified based on impact on organization goals and quality
  • Weightage to be provided for each KPI.
  • Scoring to be provided for each KPI based on actual performance.
  • Communication to top management.
  • Necessary developments to be made to improve the failed KPI
e.g. of KPI’s - Batch failures, Market complaints, deviations, Changes, OOS, Stability overdue, RM / PM / FG release time.