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block

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

Select the correct answer(s).  

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protection of material from cross contamination

all of these answers

stock rotation (FIFO)

separation of materials; quarantine; approved; rejected

none

These are quality assurance functions, except:

Select the correct answer(s).  

(0/0)

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CGMP monitoring

auditing and control of all manufacturing documents before and after production

environmental control

product forecasting

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

components are tightly sealed

improper partitioning of working areas

wrong label

none

Documentation is the main responsibility of:

Select the correct answer(s).  

(0/0)

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checking & investigation section

central release office

purchasing department

promotion and merchandising department

sales

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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production personnel control

labeling and other packaging materials

in-process analysis

inventory control

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

less than 90%

comply with DOH requirement

none

Statement of expiration date assure of:

Select the correct answer(s).  

(0/0)

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absence of interaction

absence of toxicity

recovers from ailment

full therapeutic efficacy

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

in process analysis

inventory control

inspection of container

none

In the CGMP, we usually consider the:

Select the correct answer(s).  

(0/0)

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equipment

building

all

personnel

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

none of the above

drug distributor

none

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

Select the correct answer(s).  

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b. drug substance

a. excipient

d. b and c

c.actives

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

general manager’s signature

finished product QC test results

manufacturing procedures

in-process test

none

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

impart elegance

meet BFAD requirement

comply with DOH requirement

none

Reaction kinetics study can help predict the:

Select the correct answer(s).  

(0/0)

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potency

toxicity

shelf life

effectivity of a formulation

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 31; 1999

dispense the tablets only until January 15;1999

dispense the tablets only until January 1; 1999