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In the CGMP, we usually consider the:

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all

equipment

personnel

building

none

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

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dispense the tablets only until January 15;1999

dispense the tablets only until January 1; 1999

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

dispense the tablets only until January 31; 1999

none

Statement of expiration date assure of:

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absence of toxicity

recovers from ailment

absence of interaction

full therapeutic efficacy

none

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

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general manager’s signature

dispensing batch number quantitative and qualitative formula

manufacturing procedures

in-process test

finished product QC test results

none

One of the ff. is not a QC function:

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in process analysis

inspection of container

inventory control

labeling & other packaging material

none

The barcodes imprinted in labels of products serve to:

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meet BFAD requirement

distinguish one product from another

comply with DOH requirement

impart elegance

none

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

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meet BFAD requirement

sufficient activity to be outside the USP monograph requirement

less than 90%

comply with DOH requirement

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:

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drug distributor

none of the above

drug manufacturer

drug trader

none

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

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a. excipient

c.actives

d. b and c

b. drug substance

none

Reaction kinetics study can help predict the:

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effectivity of a formulation

shelf life

potency

toxicity

none

Documentation is the main responsibility of:

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central release office

checking & investigation section

sales

purchasing department

promotion and merchandising department

none

These are quality assurance functions, except:

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environmental control

product forecasting

auditing and control of all manufacturing documents before and after production

CGMP monitoring

none

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

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all of these answers

separation of materials; quarantine; approved; rejected

protection of material from cross contamination

stock rotation (FIFO)

none

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

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wrong label

improper partitioning of working areas

components are improperly dispersed

components are tightly sealed

none

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

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inventory control

labeling and other packaging materials

production personnel control

in-process analysis