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block

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

Select the correct answer(s).  

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labeling and other packaging materials

in-process analysis

inventory control

production personnel control

none

These are quality assurance functions, except:

Select the correct answer(s).  

(0/0)

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auditing and control of all manufacturing documents before and after production

CGMP monitoring

product forecasting

environmental control

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

components are improperly dispersed

improper partitioning of working areas

wrong label

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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sufficient activity to be outside the USP monograph requirement

meet BFAD requirement

less than 90%

comply with DOH requirement

none

Reaction kinetics study can help predict the:

Select the correct answer(s).  

(0/0)

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toxicity

shelf life

effectivity of a formulation

potency

none

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

Select the correct answer(s).  

(0/0)

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finished product QC test results

in-process test

dispensing batch number quantitative and qualitative formula

general manager’s signature

manufacturing procedures

none

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

Select the correct answer(s).  

(0/0)

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b. drug substance

c.actives

a. excipient

d. b and c

none

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

Select the correct answer(s).  

(0/0)

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

dispense the tablets only until January 15;1999

dispense the tablets only until January 1; 1999

dispense the tablets only until January 31; 1999

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 distributor

none of the above

drug trader

none

The barcodes imprinted in labels of products serve to:

Select the correct answer(s).  

(0/0)

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meet BFAD requirement

distinguish one product from another

comply with DOH requirement

impart elegance

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

inspection of container

inventory control

in process analysis

none

In the CGMP, we usually consider the:

Select the correct answer(s).  

(0/0)

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building

equipment

personnel

all

none

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

Select the correct answer(s).  

(0/0)

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separation of materials; quarantine; approved; rejected

all of these answers

protection of material from cross contamination

stock rotation (FIFO)

none

Documentation is the main responsibility of:

Select the correct answer(s).  

(0/0)

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promotion and merchandising department

sales

central release office

purchasing department

checking & investigation section

none

Statement of expiration date assure of:

Select the correct answer(s).  

(0/0)

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recovers from ailment

full therapeutic efficacy

absence of interaction

absence of toxicity