Page 7 - QA and QC

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

or too slow (an efficacy/safety problem). GMP rules, particularly around the
formulation and manufacturing steps, help to make an effective product.

GOOD TO KNOW – BUILDING SAFETY INTO THE PRODUCT

Product safety is built into the product during its development cycle during
non-clinical and clinical studies. In these phases, products are tested and
investigated to see if they have unacceptable adverse effects on patients.
Manufacturers look for a range of "contra-indications” as well as the benefits
of the product. During manufacture, it is possible to adversely impact the
safety of a drug or biologic by, for example, mis-formulation, adding
ingredients in the wrong order, or not following the exact manufacturing
instructions. Changing the processing conditions or allowing product to
degrade over the shelf life will impact product safety. Applying the GMP rules

helps prevent loss of product safety.

Protecting consumers with GMP rules

To ensure that the product has adequate purity, identity, efficacy, and safety in
every manufactured unit every time, GMP rules, internal company procedures,
and manufacturing instruction must be strictly followed.

Some fundamental GMP rules include:

following manufacturing instructions, packaging instruction, and registered
formulae exactly

reporting to management any deviation to instructions

preventing contamination by:
- making sure all process equipment is clean before use
- keeping the facility clean

preventing product mix-ups by double-checking labels, segregating different
products, and conducting line clearances

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