Unit 4 Flashcards
The basic document from where the
master formula and batch production
records are based.
MANUFACTURING MONOGRAPH
The document which provides the basis
for accepting the quality of each and every component used in the manufacture of the product in accordance with the specifications and methods.
QUALITY CONTROL MONOGRAPH
The document generated to explain in detail the reason behind a procedure and proper sequence of steps to be done, and how equipment are to be operated for maximum performance.
STANDARD OPERATING PROCEDURES
(SOPs)
The original document used as the key
in the manufacture of products
MASTER FORMULA RECORD
An accurate reproduction of the master
formula record.
BATCH REPRODUCTION RECORD
It means a specific amount produced in a unit time or according to a single manufacturing order during the same cycle of manufacture
BATCH
It is a batch, a portion of a
batch, or a combination of batches.
lot
Control codes should not be identified as
such on the label. (T/F)
False (Should be)
Differences in format and content of
batch production records from product
to product are to be expected. (T/F)
True
In order to satisfy product identity,
purity, safety, quality and strength,
products must be subjected to certain
specific tests. (T/F)
True
Determines the material type,
assembly, special properties
and integrity
PACKAGING TEST
Determines the physical and
chemical reactions particular for
the compound, gives the gross
physical appearance.
IDENTIFICATION TEST
Determines the presence of
impurities: gross, chemical, and
biological
LIMIT TESTS
Determines conformance of dosage form when compared to label claim; this may be
instrumental, chemical, or biological.
ASSAYING
Tests for properties, functionalities of particular dosage forms.
DOSAGE FORM – SPECIFIC TEST
