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Why Quality is Important in Pharmaceuticals?
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Quality

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

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Quality Assurance

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

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Quality Control

Part of GMP concerned with sampling, testing and specifications.

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Organizational Structure

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

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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
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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.
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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.