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block

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 trader

drug distributor

none of the above

drug manufacturer

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

a. excipient

d. b and c

c.actives

none

Statement of expiration date assure of:

Select the correct answer(s).  

(0/0)

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absence of interaction

full therapeutic efficacy

absence of toxicity

recovers from ailment

none

Documentation is the main responsibility of:

Select the correct answer(s).  

(0/0)

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purchasing department

promotion and merchandising department

checking & investigation section

central release office

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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in-process analysis

labeling and other packaging materials

inventory control

production personnel control

none

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

Select the correct answer(s).  

(0/0)

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in-process test

dispensing batch number quantitative and qualitative formula

finished product QC test results

general manager’s signature

manufacturing procedures

none

In the CGMP, we usually consider the:

Select the correct answer(s).  

(0/0)

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all

equipment

building

personnel

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

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

Select the correct answer(s).  

(0/0)

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stock rotation (FIFO)

protection of material from cross contamination

all of these answers

separation of materials; quarantine; approved; rejected

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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comply with DOH requirement

less than 90%

meet BFAD requirement

sufficient activity to be outside the USP monograph requirement

none

The barcodes imprinted in labels of products serve to:

Select the correct answer(s).  

(0/0)

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comply with DOH requirement

meet BFAD requirement

impart elegance

distinguish one product from another

none

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

Select the correct answer(s).  

(0/0)

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wrong label

components are tightly sealed

components are improperly dispersed

improper partitioning of working areas

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

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 1; 1999

dispense the tablets only until January 15;1999

none

One of the ff. is not a QC function:

Select the correct answer(s).  

(0/0)

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in process analysis

inspection of container

inventory control

labeling & other packaging material