Unit 3 Flashcards
Each container of raw materials is examined visually for damage or contamination in transit, including breakage of seals when indicated.
Materials Control
assigned to each
batch received from the supplier
Receiving number
A receiving number is not distinct (T/F)
False (Distinct)
It is a completed upon receipt of material.
Receiving Tally Report (RTR)
A document used to record the amount
and type of finished goods or raw
materials when a shipment has been
accepted.
Receiving tally report
Information under PRE-PRINTED DATA (5)
Name of report
Name of drug/cosmetic company
Address
Receiving number
Name of the department receiving a copy
(2) subtypes of INFORMATION TO BE SUPPLIED
Warehouse
Quality control
Information under Warehouse
Name of the material
Item code number
Label claim
Purchase order number
Invoice number
Vendor (supplier/distributor)
Unit of measure
Number of containers received
Weight/volume/pieces contained in each container.
Date of the report was prepared
Date of the shipment was received
Name of the warehouse personnel receiving the shipment
Information under quality control
Inspector’s report
Analysis
Disposition
Name of the person responsible for receiving the report
Date of review
The RTR is prepared not in the warehouse (T/F)
False (In warehouse)
Manufacturing firms may have different
entries but the basic information is quite
similar. (T/F)
True
These are performed to determine conformance to specifications for properties that can be checked by appearance, odor or flavor.
ORGANOLEPTIC INFORMATION
Used as an aid in verifying the identity
of articles as they are purported to be,
e.g., those taken from labeled contain
and to establish whether it is the article
named in USP–NF.
IDENTIFICATION TESTS
Used in determination of strength, potency, or
purity of the material.
ASSAY
Determines presence of living
organisms which compromises the
quality of the material such as
pathogens
MICROBIOLOGICAL TESTS
Tests to limit such substance to amounts
that are unobjectionable under
conditions in which the article is
customarily employed.
LIMITS OF IMPURITIES AND FOREIGN
SUBSTANCES
Periodic testing is done to revalidate
the material.
REASSAY DATE
REASSAY DATE of – highly unstable materials
Monthly or prior to use
REASSAY DATE: vitamins, flavorants
6 months
REASSAY DATE: active ingredients,
dyes
12 MONTHS
REASSAY DATE: excipients
24 months
These tests are intended to
provide protection from light as
specified by the standard.
Light Transmission
These test are intended to
provide protection from moisture
permeation as specified by the
standard
Water Vapor Permeation
Used to create rigid translucent
lightweight bottles that can withstand solvents or weak acids and bases.
Polyethylene terephthalate (PET)
