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level: Level 5 PRODUCT QUALITY TESTS COMMON TO PARENTERAL DOSAGE FORMS

Questions and Answers List

level questions: Level 5 PRODUCT QUALITY TESTS COMMON TO PARENTERAL DOSAGE FORMS

Question	Answer
Universal Product Quality tests	1 Identification tests 2 Assay 3 Test for impurities & Foreign substances 4 Test for foreign and particulate matter 5 Test for sterility 6 Test for bacterial endotoxins (PYROGEN, LAL) 7 Packaging systems 8 Container content 9 Container closure integrity 10 Labeling
Aid in verifying identity of articles as they are purported to be Necessary to establish/conform the identity of an article	Identification tests
specific stability tests is used to determine the strength (content) of the drug product. A specific procedure should be used when there is evidence of excipient interference with the nonspecific assay. In cases where the use of nonspecific assay is justified, other analytical procedures should be used to achieve overall specificity	Assay
Acceptance criteria for impurities in drug substances should be based on chemical characteristics and safety considerations	Test for impurities & Foreign substances
Impurities in drug substances are classified into the following three categories:	1) organic impurities (process and drug-related) 2) inorganic impurities, and 3) residual solvents
can arise during the manufacturing process and/or storage of the drug substance. They can be identified or unidentified, volatile or nonvolatile (Starting materials, Byproducts, Intermediates, Degradation products, Reagents, ligands, and catalysts, Residual solvents)	Organic impurities
can result from the manufacturing process. They are usually known and identified. (reagents, ligands, catalysts, inorganic salts, heavy metals)	Inorganic impurities
Particulate matter in injections and parenteral infusions consists of mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions every container where contents show evidence of visible particulates is rejected Inspection of visible particulates may take place during the examination of other defects, such as cracks or defective containers/seals, or when characterizing the appearance of a lyophilized product	Test for foreign and particulate matter:
applied for substances, preparations or articles that are required to be sterile as required by the Pharmacopoeia Carried out under aseptic conditions: Precautions taken to avoid contamination - monitored regularly	Test for sterility
test to detect bacterial endotoxins from gram -ve bacteria using the amoebocyte lysate from the horseshoe crab: (LAL Test) carried out in a manner that avoids endotoxin contamination these tests limit endotoxins present in the parenteral products	Test for bacterial endotoxins
designed to limit to an acceptable level the risks of febrile reactions of patients to injections. Carried out by measuring rise in rabbits' temperature	Pyrogen test
The sum of Packaging components and materials that together contain and protect the article. This includes Primary packaging components as well as Secondary packaging components	Packaging systems
Each container of an injection contains sufficient excess to allow withdrawal of the labeled quantity of drug packaging system should be closed or sealed in a manner as to prevent contamination or loss of contents	Container content
continues throughout the products' life cycle required in the whole life cycle of the product	product package integrity testing
3 phases of Integrity testing	1.) initial development of packaging system 2.) routine manufacturing 3.) shelf-life stability assessments
1 physical and microbial tests performed 2 determine if packaging or capping system is operating consistently as to performance acceptance range 3 confirm integrity as to acceptance values	1 during initial development 2 routine manufacturing 3 shelf-life stability assessments
all labels and other written, printed, or graphic matter on an article’s immediate container or on, or in, any package or wrapper in which it is enclosed, except any outer shipping container. The names and strengths of drug products and compounded preparations formulated with a salt of an acid or base are to be expressed in terms of the active moiety on the label The labeling clearly states the specific salt form of the active moiety that is present in the product or preparation because this information may be useful to practitioners and patients	Labeling