Dosage Quiz

43- According to ability of containers to protect their content from ordinary external condition of handling, shipment, storage, and distribution, which is not true? A- Amber glass or opaque plastic containers can sufficiently protect a moisture sensitive pharmaceutical substance B- Hermetic containers can maintain sterilization of preparations intended for injection or parenteral administration C- Tightly close containers can protect contents from contamination by liquids, solids or evaporation D- Well closed containers can just protect content from solid or prevent content loss E- None of them

Regarding the common terms in GMP, Which of following term is defined correctly? A- Certification: is the extent to which manufacturer is acting with prescribed regulations, standards, and practices B- Process validation is prospective experimental plan to produce documented evidence that the system has been validated C- Compliance is documented testimony by qualified authorities that a system qualification, calibration, validation, revalidation has been performed appropriately and that the results are acceptable D- Quarantine is a marked, designated area, or set aside for the holding of incoming components prior to acceptance test and qualification for use E- None of them

Regarding control of components, containers and closures regulations, which one is not true? A- The label of quarantined rejected raw material is not enough to carry only name of material B- Raw materials should verified through sampling for qualitative and quantitative analysis C- Starting raw materials do not necessarily need to be tested if there is a batch analysis certificate from the supplier D- Validation of Identification, storage, handling, and approval or rejection of all product components, containers, and closures must be maintained and followed E- None of them

Regarding different type of package, Which of the following packaging type is described correctly? A- Tamper-evident packaging means a container that is fitted with a closure that is significantly difficult to open by children less than 5 years of age B- Moisture resistance container is obtained by adding UV absorbance to transparent plastic C- Single dose parental container is one that allow withdrawal of successive dose without changing of the content quality D- Compliance packaging means unit or quantity of drug to be use, so it is useful for patients taking multiple medications E- All of them

Chapter 3 2022-2021 / الدور الأول ⬇️

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