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block

The barcodes imprinted in labels of products serve to:

Select the correct answer(s).  

(0/0)

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distinguish one product from another

meet BFAD requirement

impart elegance

comply with DOH requirement

none

Statement of expiration date assure of:

Select the correct answer(s).  

(0/0)

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recovers from ailment

absence of toxicity

absence of interaction

full therapeutic efficacy

none

One of the ff. situations can avoid cross contamination and mix-ups:

Select the correct answer(s).  

(0/0)

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components are tightly sealed

wrong label

improper partitioning of working areas

components are improperly dispersed

none

Reaction kinetics study can help predict the:

Select the correct answer(s).  

(0/0)

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effectivity of a formulation

shelf life

potency

toxicity

none

If a bottle of tablets has an expiration date of January 1999, the pharmacist may,

Select the correct answer(s).  

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dispense the tablets only until January 1; 1999

dispense the tablets only until January 31; 1999

dispense the tablets only until January 15;1999

continue to dispense the product if he has already opened the container

none

The manufacturing batch record should contain the ff. information, except:

Select the correct answer(s).  

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manufacturing procedures

dispensing batch number quantitative and qualitative formula

in-process test

finished product QC test results

general manager’s signature

none

Documentation is the main responsibility of:

Select the correct answer(s).  

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purchasing department

promotion and merchandising department

checking & investigation section

central release office

sales

none

The expiration date of paracetamol tablet states January 1999. This statement means that, by January 1999, the product will have lost its activity:

Select the correct answer(s).  

(0/0)

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meet BFAD requirement

sufficient activity to be outside the USP monograph requirement

comply with DOH requirement

less than 90%

none

The QA inspectors usually inspect and audit warehouse CGMP’s :

Select the correct answer(s).  

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separation of materials; quarantine; approved; rejected

all of these answers

stock rotation (FIFO)

protection of material from cross contamination

none

These are quality assurance functions, except:

Select the correct answer(s).  

(0/0)

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CGMP monitoring

product forecasting

environmental control

auditing and control of all manufacturing documents before and after production

none

It means any establishment engaged in operations involved in the production of drugs including propagation, processing, compounding, finishing, filling, packing, repacking, and labeling in view of storage distribution or sale of the product:

Select the correct answer(s).  

(0/0)

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drug manufacturer

drug trader

drug distributor

none of the above

none

In the CGMP, we usually consider the:

Select the correct answer(s).  

(0/0)

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building

all

equipment

personnel

none

The production department of a pharmaceutical manufacturing establishment is in charge of, except:

Select the correct answer(s).  

(0/0)

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inventory control

labeling and other packaging materials

production personnel control

in-process analysis

none

Any substance of a drug product intended to furnish pharmacologic effect is:

Select the correct answer(s).  

(0/0)

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a. excipient

c.actives

d. b and c

b. drug substance

none

One of the ff. is not a QC function:

Select the correct answer(s).  

(0/0)

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labeling & other packaging material

inventory control

in process analysis

inspection of container