Page 3 - Introduction QC

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

laboratory conditions to determine their safety. The term does not include
studies utilizing human subjects or clinical studies or field trials in animals.
The term does not include basic exploratory studies carried out to determine
whether a test article has any potential utility or to determine physical or
chemical characteristics of a test article."

G(QC)LP: GOOD (QUALITY CONTROL) LABORATORY PRACTICES

Refers to the laboratory practices and procedures within a laboratory that
conducts regulated quality control testing, usually the results are used for
commercial reasons.

It is well-documented that working within a documented quality systems
framework will provide more consistency in laboratory processes, which will in
turn improve the laboratory efficiency through error minimization.

Think of the consequential problems if, through a laboratory error, a batch is
rejected when it is actually satisfactory: the company will lose the income that
would have been generated from that batch. Even worse would be the situation
where QC incorrectly passed a defective batch this may have critical
consequences for the company, through harm to patients, recall of the batch,
and loss of confidence in the company by the regulators and the public. Rather
than simply being an overhead, the QC laboratory is often the last chance to
catch a problem before it becomes much bigger.

What do the GMP rules say?

US FDA CFR 211

Sec. 211.160 General requirements.
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