Section II. QUALITY CONTROL
INTRODUCTION TO QUALITY CONTROL
Quality control is an important term in pharmacy. Patient lives, as well as the
reputation of the pharmacy, depend upon quality control procedures. This section will
focus on quality control procedures that can be used in the manufacturing section.
a. Definition. Quality control is a process which builds high quality into a
product by ensuring the use of good raw materials and the adherence to a rigid set of
good manufacturing practices during every step of the manufacturing process. Quality
control begins with checking raw ingredients and continues by performing many checks
throughout the production process. Quality control ensures that the correct number of
labels are printed and used for each batch of a manufactured product. Quality control
procedures are used to ensure that the manufactured product meets the standards that
have been established for its use.
b. Quality Control Information. Each particular manufactured product has
certain characteristics that can easily be determined. Originally, when the product was
first formulated, these characteristics (for example, specific gravity, refractive index,
and/or pH were determined and established on the Master Formula Card for that
particular product see figure 2-12). Always be familiar with this area of the Master
Formula Card because it clearly describes the standards the product must meet before
it can be dispensed to patients.
QUALITY CONTROL TESTS
The following quality control tests are used to evaluate manufactured products to
ensure their quality and purity for patient use.
a. Visual Inspection. With visual inspection, the ingredients and the final
products are carefully examined for purity and for appearance.
b. Specific Gravity. Specific gravity is defined as the weight (in grams) of a
substance per unit volume (in milliliters). Each prepared product has a characteristic
specific gravity. A device called a hydrometer tube is used to measure the specific
gravity of a liquid preparation. If the specific gravity of a prepared product does not
meet established standards for that product, the product must not be dispensed to
c. Refractive Index. The refractive index is a measure of the degree of the
bending of light, which passes through the substance. The refractive index of a
substance is measured with a device called a refractometer. Again, each product has
an established refractive index.