Quality Control is any analysis which is performed per
Standard Operating Procedures using approved methods and
techniques. Your testing is "controlling the quality" of
Quality Assurance are they procedures perfomed to "ensure
the quality" of the product. So those SOPs and procedures
used, the calibrations of the instruments, the document
reviewing, the maintenace procedures, etc are all part of
QC- is ensure the total quality of of the Drugs in
differnet stages (Raw,Intermediate and FG)using very
stringent policys and meet the product for international
regulatory needs. QC is the significant Department under QA.
QA- is working for the total quality of the manufacturing
process and enusring that all the system which is requiered
for cGMP. QA have right to amend or impliment changes in
the system.Cosider one drawing: we are using may colours,
colours are the deparments in a system and we are using
brush for sketch the idea. If the brush is damaged the
total picture is become bad.
Both QC and QA are belongs to one unit that is Quality
Unit. Quality Control (QC) who ensures the quality of the
product (From starting material, Inprocess, Intermediate,
Finished product and packing materials)by using different
procedures (Standard Operating procedures, Specification
and Method of analysis and Good Laboratory Practices) whcih
are Approved by Quality Assurance.
But Quality Assurance is not only ensures the quality of
the product they prepared and approved guidelines to all
departments to prepare the product,Equaipment qualification
procedures and they monitor entire operating procedures and
and make sure that the compay is following GMP (By
preparing standard operating procedures) if any body want
to know functions of quality please go through ICH Q7 2.2
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Other Analytical Chemistry Interview Questions
why we want incorporate area of each solution of Intermediate precision and repeatability as well as Accuracy ?
What is the use to incorporate area of each solution of Intermediate precision and repeatability as well as Accuracy ?