Totality features or conformance t specifications of a product

Regular periodic quality reviews of all registered drugs

Systematic process for the assessment, control, commnication, and review of risks to the quality of the product

A set of activities that ensures qualiy in the process by which the products are developed. Prevent defects. Process oriented

Set of activities that ensures quality in products and is focused on identifying defects in the products produced. Identify and correct defects. Product oriented

Reflects the quality attributess of medicines

Contains important information about the properties of a particular hazardous substance. How to safely handle store, and dispose it.

Most common (old). Uses master tables

Most common (new)

Used in the exam. Easier

May cause death or serious adverse health consequence

Eectent to which a product remains stable and within specifications

Period of time during which a product is expected to remain within specification

Date beyod which product loses stability

Conducted under normal conditions

Elucidates the intrinsic stability of the drug substance and identify the likely degradation products. Under more severe conditions

Uses a cylinder or plate disc impregnated with sample, placed on solidified nutrient medium in a petri dish. Base on zone of inhibition

Uses test tubed filled with fluid nutrient medium. Test organism is inoculated. Transmittance

Niacin (B3), Pantothenic acid (B5)

Cobalamin

Chloramphenicol

Bacitracin

Streptomyin

Vancomycin

Dirt or insoluble matter

Microorganisms

Hydrogen sulfide

Silver diethyldithiocarbamate

Ammonium thiocyanate

Silver nitrate

Barium chloride

Can be used for identification and determination of conentration of a component

The ratio of the density of a substance to that of a reference substance. Measured using pycnometer or mhor westphal balance

Ratio of the velocity of light in air to the velocity of light in the substance. Measured using abbe refractometer

Measure of its abiityy to rotate an incident plane of polaized light. Polarimeter

Component of karl fischer titrimetry, except:

Based on the ditillation of water and toulene or xylene

Based on loss on drying at 110-120 for inorganic materials and 105 for organic materials

Leaching

Test for glass except

For colored containers

For type 1 and 2 glass container. Limit: NMT 0.1 mcg/g

Most reliable particle size distribution analysis

Fastest particle analysis. Use 25 g of sample

2 tangents separated by the longest distance

Distance that will bisect the particle into halves

Diameter of the circle that will enclosed the particle

Vp + intraparticle spaces

Vg + interparticle spaces

Measures volume to determine density (constant wt)

Measure weight to determine density (constant volume)

Conventional and ordinary coated tablet

SL and chewable

Buccal

Used to measure tablet thickness

Determines tablet durability. Uses roche or vanderkaamp

For semisolids with labeled content of nmt 150mg or 150ml

Applicable for liquid product nmt 250ml

For steam / moist heat method

For dry heat and ethylene oxide

For ionizing radiation

Protects from extraneous solids and loss of article

Solids, liquids, and vapors; loss of article, moisture

Impervious to air