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
During processing, the quality of the
product at various stages of production
is audited by quality control.
IN-PROCESS CONTROL
An important requirement of GMP is that
the packaging and labeling facilities are
inspected before use to assure that all
drug product have been removed
LINE CLEARANCE
Clean rooms; class 100 and below
have unidirectional airflow pattern.
Unidirectional
Conventional flow clean rooms (class
1000 & 10000) have non-unidirectional or mixed air flow patterns
Non-unidirectional
an environment where the particulate contamination & bacterial contamination are limited to prescribed levels.
‘Clean Room
Types of Clean Room Air Filters (2)
High Efficiency Particulate Air (HEPA)
Ultra Low Penetration Air (ULPA)
Minimum particle collective
efficiency of 99.97 to 99.997%
for a 0.3 micron particle
High Efficiency Particulate Air
(HEPA)
Minimum particle collection
efficiency of 99.9997% efficient
for particles greater than or
equal to 0.12-micron in size
Ultra Low Penetration Air (ULPA)
A process in which the HEPA and ULPA filter is
challenged by introducing dispersed
particulates, in a form or aerosol, and is
measured using a probe.
filter integrity testing
Substance used in filter integrity testing
Di-octylphthalate
PAO (Polyalphaolefin)
The contamination of a starting material,
intermediate product or finished product
with another starting material or product
during manufacture
Cross contamination
Focuses on acceptable product
outputs and is usually needed for
production processes.
Yield
focuses on losses or apparent gains of materials, and is usually used for labelling and packaging operations
Reconciliation
Compares the amount of material going into a process with the amount coming out of the
process.
Reconciliation
