Page 10 - QA and QC

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

GMP KNOWLEDGE AND BEHAVIOR

Knowing how the product is used by patients and
clinicians and what effects it may have if incorrectly

manufactured provides important understanding for
QUALITY manufacturing personnel. This knowledge enables
KNOWLEDGE people to better recognize why certain rules are
required, and hopefully recognize when
manufacturing deviations may cause patient
concerns.

All international GMP rules require formal training in

good manufacturing practices across all levels of
GMP management and personnel, the reason for this is
KNOWLEDGE that the rule have been developed over 50 years, and

contain practical experiential-based requirements to
prevent manufacturing errors and defective product.

Manufacturing personnel should be trained and have

knowledge of the products that they produce and the
PRODUCT / processes that they use, this information is often
PROCESS
KNOWLEDGE documented in the master batch or master
packaging records. Personnel should be familiar with
these before they manufacture any product.

Minimizing human error in a manufacturing
environment is one of the key factors that ensure
products are produced in a safe and effective
GMP manner. Personnel should always keep in mind that
BEHAVIOR
they are making products that are often essential life-
saving medicines. The end user relies upon
compliant GMP behavior to assure product quality.

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