A Review - Quality Assurance & Quality Control

Abstract

Quality Assurance (QA) and Quality Control (QC) are complementary systems ensuring product quality, with QA being process-focused and preventative (building quality in through standards and procedures) and QC being product-focused and reactive (inspecting and testing to find defects in finished goods). Together, QA sets the framework and QC verifies the outcome, both vital for meeting customer needs, adhering to regulations, and delivering safe, effective products in fields from software to pharmaceuticals.

Introduction

Quality assurance (QA) and quality control (QC) are complementary aspects of quality management in the pharmaceutical industry. Both ensure that products meet required standards, but they differ in approach and focus.

Quality Assurance (QA)

• Definition: QA is a proactive, process-oriented approach aimed at ensuring that quality requirements are consistently met.

• Purpose: Builds confidence internally (management) and externally (clients, regulators) that products are of high quality.

• Functions:

  • Approving and sourcing raw materials from certified vendors.

  • Maintaining accurate records in compliance with cGMP.

  • Ensuring proper procedures, equipment calibration, and process standardization.

• Steps: Plan → Design & Develop → Implement → Train → Document & Report → Continuous Improvement.

• Applications:

  • Prevent defects by designing correct processes.

  • Improve processes through audits, risk assessment, and training.

  • Standardize methodologies and quality policies (e.g., ISO 9001).

  • Provide confidence that quality requirements will be met.

Quality Control (QC)

• Definition: QC is a reactive, product-oriented approach focused on detecting and correcting defects in the finished product.

• Purpose: Ensures that the final product meets defined standards before release.

• Steps: Define Standards → Inspect & Test → Monitor → Compare & Identify Deviations → Corrective Action → Continuous Improvement.

• Applications:

  • Detect defects through inspections, testing, and reviews.

  • Verify product compliance with specifications.

  • Correct issues iteratively until quality standards are met.

  • Evaluate final products before release.

Key Differences

Conclusion

Quality assurance can be delineated as “section of quality management emphasized on furnishing confidence that quality must-have will be performed.” The confidence furnished by quality assurance is twofold intrinsically to management and extrinsically to clients, government agencies, regulators, certifiers, and third parties. An alternate delineation is “entire the planned and systematic activities performed within the quality system that can be substantiated to furnish confidence that a commodity or service will perform must-have for quality.”Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. Quality control is a product-oriented process. Quality control makes sure the end product meets the quality requirements Quality control can be noted as a reactive process.

References

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Copyright

Copyright © 2025 Ravi Kant Tiwari , Pramod Mishra, Sujeet Pratap Singh, Dr. Tarkeshwar P. Shukla. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.