QA and QC - Pharday QB

What mathematical formula is designated as the square root system for sampling population N in quality control

n=sqrt(N)+1

What control chart type is utilized specifically for tracking the proportion of defectives

p-Chart

What control chart type is utilized specifically for tracking the non-proportion or number of defectives

np-Chart

What control chart type is utilized for measurable characteristics

X Bar Chart

What limit on a control chart alerts the operator to stop the process and do corrective action

Action limit

What limit on a control chart alerts the operator to closely monitor the process

Warning limit

What action of proving and documenting that any process, procedure or method actually leads to expected results is termed

Validation

What action of proving that premises, systems or equipment work correctly and actually lead to expected results is termed

Qualification

What product defect classification describes a defect that may endanger the life of the patient

Critical Defect

What product recall class denotes situations that may cause death or serious adverse health consequences

Class I Recall

What product recall class denotes situations that are not likely to cause adverse health consequences

Class III Recall

What is the specified minimum acceptable potency percentage for a drug to remain within specification

90%

What mathematical equation is utilized to estimate the shelf-life of a drug product based on rate constants and temperature

Arrhenius equation

What climatic zone type corresponds to a temperate climate with 21±2°C and 45±5% humidity

Zone I

What climatic zone type corresponds to hot and very humid conditions such as the Philippines with 30±2°C and 75±5% humidity

Zone IVB

What animal species is specified as the test model for the biological assay of Digitalis

Pigeon

What animal species is specified as the test model for the biological assay of Tubocurarine

Rabbit

What animal species is specified as the test model for the biological assay of Glucagon

Cat

What animal species is specified as the test model for the biological assay of Chorionic Gonadotropin

Female Rat

What animal species is specified as the test model for the biological assay of Oxytocin

Chicken

What animal species is specified as the test model for the biological assay of Parathyroid Hormone (PTH)

Dog

What animal species is specified as the test model for the biological assay of Heparin

Sheep

What test organism is utilized in the microbial assay of Penicillin G

Staphylococcus aureus

What test organism is utilized in the microbial assay of Bacitracin

Micrococcus luteus

What test organism is utilized in the microbial assay of Streptomycin

Klebsiella pneumoniae

What test organism is utilized in the microbial assay of Chloramphenicol

Escherichia coli

What test organism is utilized in the microbial assay of Vancomycin

Bacillus subtilis

What test organism is utilized in the microbial assay of Niacin

Lactobacillus plantarum

What test organism is utilized in the microbial assay of Cyanocobalamin

Lactobacillus leichmanii

What reagent is specified for the limit test of heavy metals yielding a color reaction

Hydrogen Sulfide TS

What reagent is specified for the limit test of arsenic

Silver Diethyldithiocarbamate TS

What reagent is specified for the limit test of iron

Ammonium Thiocyanate TS

What reagent is specified for the limit test of chloride

Silver Nitrate TS

What reagent is specified for the limit test of sulfate

Barium Chloride TS

At what precise temperature in degrees Celsius is the specific gravity of alcohol measured using a hydrometer

15.56°C

What instrument is used to measure the refractive index of a substance

Abbe refractometer

What descriptive solubility term is assigned when 1 part of solute requires from 30 to 100 parts of solvent

Sparingly Soluble

What descriptive solubility term is assigned when 1 part of solute requires from 1,000 to 10,000 parts of solvent

Very Slightly Soluble

What official Karl Fischer titration method is classified as Method IA

Direct

What official Karl Fischer titration method is classified as Method IB

Residual

What official Karl Fischer titration method is classified as Method IC

Coulometric

What specific glass type test involves crushed Type I and Type III glass analyzed via acid-base titration with 0.2N H2SO4 VS

Powdered Glass Test

What specific glass type test is performed on the inner surface of Type II glass

Water Attack Test

What specific glass type test is performed on the inner surface of Type I and III glass using 0.1N HCl VS

Surface Glass Test

What new USP glass test distinguishes Type I glass from Types II and III

Glass Grains Test

What new USP glass test distinguishes Type I from Type II glass

Surface Etching Test

What maximum light transmission percentage limit is specified for colored glass containers in the range of 290 to 450nm

NMT 10%

What maximum limit in micrograms per gram is specified for arsenic in Type I or Type II glass containers

0.1 µg per g

What animal model is specified for the Systemic Injection Test in biological reactivity tests in vivo

Albino mice

What animal model is specified for the Intracutaneous Test in biological reactivity tests in vivo

Albino rabbits