[1] Quality and Defects

sum of all factors which contribute directly or indirectly to the safety, effectiveness, and reliability of the product

quality

final authority for product acceptance or reject

quality assurance

process oriented

quality control

sampling and analytical testing of incoming raw materials and inspection of packaging components

quality control

length, weight, volume, size particles are what kind of measurability?

variable defect

conformance or non conformance of the material to the specifications

attribute defect

it affects the functions of the product and therefore, may render the product useless

major defect

presence of crack in a bottle is classified under:

major defect

it contaminates liquid preparation is classified under:

critical defect

slight discoloration is classified under:

minor defect

it is the type of defect that is visible

occular defect

suppository does not melt in body temperture is classified under:

critical defect

undesirable chracteristic of a product

defects

which of the ff is correct:

major defect: sub potent

which of the ff is not considered as attribute defect?

size particles

it perfoms on environmental monitoring

quality control

conduct the required tests on finished dosage form

quality control

quality monitoring or aduit function

quality assurance

which of the ff statement is incorrect:

occular defect is determined by the presence of cotton fibers