Page 30 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

production conditions are documented in the
master production and master packaging
instructions, the instructions are followed by
operators, and the process is monitored to ensure
that it stays in control.

Batch records provide evidence whether or not

the process remained in control.

Managing Deviation:
A deviation occurs when the batch processing is
not performed exactly as per the master
instructions or SOPs. When a deviation does
occur, GMP requires it to be formally documented

and reported to QA for review.

All deviations must be resolved before a batch can
be released to market.

Contamination Control:

A medicinal product is consumed by patients that
are unwell or otherwise vulnerable. If the product
is contaminated, this may be a health hazard for
the patient. GMP rules are largely written to
prevent the possibility of contamination of
products either by other products, the
environment, the facility, personnel, equipment
or microbiologically.

GMP rules also place particular emphasis on
proper and validated cleaning and sanitation
procedures.

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