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block

Statement of expiration date assure of:

Select the correct answer(s).  

(0/0)

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full therapeutic efficacy

recovers from ailment

absence of toxicity

absence of interaction

none

In the CGMP, we usually consider the:

Select the correct answer(s).  

(0/0)

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personnel

equipment

building

all

none

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

Select the correct answer(s).  

(0/0)

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c.actives

d. b and c

b. drug substance

a. excipient

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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less than 90%

meet BFAD requirement

comply with DOH requirement

sufficient activity to be outside the USP monograph requirement

none

Reaction kinetics study can help predict the:

Select the correct answer(s).  

(0/0)

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shelf life

effectivity of a formulation

toxicity

potency

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 distributor

none of the above

drug trader

drug manufacturer

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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dispense the tablets only until January 15;1999

dispense the tablets only until January 31; 1999

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

dispense the tablets only until January 1; 1999

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

Documentation is the main responsibility of:

Select the correct answer(s).  

(0/0)

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promotion and merchandising department

sales

checking & investigation section

central release office

purchasing department

none

One of the ff. is not a QC function:

Select the correct answer(s).  

(0/0)

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inventory control

inspection of container

labeling & other packaging material

in process analysis

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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labeling and other packaging materials

production personnel control

in-process analysis

inventory control

none

These are quality assurance functions, except:

Select the correct answer(s).  

(0/0)

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product forecasting

CGMP monitoring

environmental control

auditing and control of all manufacturing documents before and after production

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 improperly dispersed

improper partitioning of working areas

wrong label

components are tightly sealed

none

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

Select the correct answer(s).  

(0/0)

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dispensing batch number quantitative and qualitative formula

in-process test

finished product QC test results

manufacturing procedures

general manager’s signature

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

stock rotation (FIFO)

protection of material from cross contamination

all of these answers