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Lesson 2. Introduction to Manufacturing, Quality Control, and Prepackaging. - Compounding and Manufacturing

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LESSON 2
INTRODUCTION TO MANUFACTURING, QUALITY CONTROL, AND
PREPACKAGING
Section I. PHARMACEUTICAL MANUFACTURING
2-1.
BACKGROUND INFORMATION
a. Definition. Pharmaceutical (bulk) manufacturing is the compounding of large
quantities of a pharmaceutical product that is designed to be dispensed to more than
one patient.
b. Justification. There are two primary justifications for pharmaceutical (bulk)
manufacturing in the modern pharmacy.
(1)  In some cases, a commercially available product can be manufactured
in the pharmacy in order to save money. Obviously, all the costs (for example,
ingredients, equipment, and manpower) must be considered when this justification is
used.
(2)  In other circumstances, a product is manufactured because an
equivalent product is not commercially available. For example, if a dermatologist were
to frequently prescribe a particular ointment that is not commercially available, it would
be cost effective to manufacture this product rather than to compound each individual
prescription for the ointment.
2-2.
FORMS USED IN THE MANUFACTURING SECTION
As you might anticipate, there are no specific manufacturing forms that are used
in all U.S. Army medical treatment facilities (MTFs). This subcourse will merely provide
guidance on the types of information that should be contained on certain forms used
within the manufacturing section. Again, it is important to realize that forms are tailored
to meet the individual needs of a particular MTF. So, the forms you see in your MTF
might contain more or less information than you see on the forms used to train students
in the 91Q Pharmacy Specialist Course.
a. Bulk Compounding Formula Record (Master Formula Card). The Bulk
Compounding Form (Master Formula Card) is the official recipe for a particular product
compounded in the pharmacy. The Master Formula Card (see figure 2-1) contains
specific information on the preparation, packaging, and labeling of a product. Observe
that the Master Formula Card is designed to tell you everything you need to know about
the preparation of a product.
MD0809
2-3



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