Page 50 - Introduction QC

GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com

obtained from existing production material of high purity ifthere is no other
external primary standard available

prepared by further purification of existing production material
Secondary reference standards are also substances of established quality and
purity, usually prepared in-house. These standards can only be used if they are
standardized against primary standards using definitive methods that are
published in pharmacopoeias, and national and international standards.

Wherever economically possible, primary standards should be used.

GOOD TO KNOW – REAGENTS AND STANDARD SOLUTIONS

Reagents made up in the laboratory should be prepared following standard
procedures. As applicable, labelling should indicate the concentration,
standardization factor, shelf life, and storage conditions. The label should be
dated and signed or initialed by the person preparing the reagent.

Where relevant, a date for re-standardization should be recorded. In certain
cases, it may be necessary to carry out tests to confirm that the reagent Is
suitable for the purpose for which it is to be used. A record of these tests should
be maintained. Where appropriate, purchased reagent solutions should be
dated upon receipt.

The accuracy and precision of tests results and test methods is dependent on
the reliability, authenticity, and control over reference standards, reagents,
and stock solutions.

Similarly, the retrospective testing of materials and product is dependent on
the protection and storage of retention samples.

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