Page 49 - Introduction QC

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

any precautions

Pharmacopoeias

Pharmacopoeias are published standards often recognized by regulatory
agencies as official standards. Many countries make compliance to
pharmacopoeias a condition of release to market for each batch. Any official or

legal methods will prevail in any dispute situation.

The main sections included in pharmacopoeias are:

general notices for dose forms (e.g. tablets, liquids, sterile products)

monographs for raw materials and products, covering the official tests, test
methods, and information on how to conduct particular tests

guidance on conducting general tests

preparation of standard reagents

Products and raw materials that are compliant to pharmacopoeias must
continue to comply during the entire lifetime of the goods.

Where a pharmacopoeia is applicable to a starting material, this is a minimum
specification, and the QC specifications used should at least conform to it.

Reference standards

A primary reference standard is a substance that has been shown by an
extensive set of analytic tests to be authentic material that should be of high
purity. Primary standards are recognized by the pharmacopoeias and regulatory

agencies as the official industry standards for particular tests.

Primary standards can be:

obtained from an officially recognized source

prepared by independent synthesis

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