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What is Difference between Quality Control and Quality Assurance?

What is Difference between Quality Control and Quality Assurance?

Pharmaceutical Guideline1 min read
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What is the Difference between Quality Control (QC) and Quality Assurance (QA)?

I am asking this question to many fresher candidates in the interview; to evaluate their awareness about the pharmaceutical industry and the work functions of the various departments

This answer has two levels,

  • Basic level answer
  • Advanced level answer

If the question is asked to a fresher candidate; the basic level answer is acceptable, but if the candidate is experienced; the advanced level answer is expected by the interviewer to evaluate the conceptual clarity about the departmental responsibilities.

  • Basic level answer

  • Quality Control function is related to analysis as per validated and approved Method and the result shall be compared with the pre-defined approved specification.

means, QC is related to the testing of the product

  • Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.

means, QA is ensuring the quality of the product at all the stages of the product life-cycle

  • Advanced level answer

There is 7 (seven) conceptual difference between QA and QC

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General

Purified Water [PW]

PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.