Page 6 - QA and QC

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

GOOD TO KNOW - CONTAMINANTS

Products are expected to be pure, in that they must not contain any
unapproved ingredients or any contaminants. If a product is not pure, it may
have an adverse effect on a patient and would therefore become unsafe. An
obvious example is bacteria in a sterile product.
GMP rules throughout manufacture of the ingredients and the product help

us make a pure product.

GOOD TO KNOW – PRODUCT LABELLING

Patients and healthcare professionals rely upon the labelling of a product to
ensure that they take the right product and the right strength in the prescribed
way.

Product labelling, if wrong, can significantly impact patient health and even
cause death. GMP rules, particularly during the packaging steps, help prevent
the product from being misidentified.

GOOD TO KNOW – FACTORS AFFECTING EFFICACY

During clinical trials, products are verified that they "work", or are effective.
This is confirmed by regulatory agencies when products are approved for
commercial manufacture.

Efficacy is largely affected by the amount of active ingredient in the product.
For example, 100mg of aspirin is more effective than 50mg in most cases, so
it's important to formulate the exact amount only.

The product excipients (non-active chemicals) can also affect efficacy. For

example, some drugs release slowly into the bloodstream due to the right
excipients being present. If not, they might release too fast (a safety problem)

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