[QC2] STATISTICAL QUALITY CONTROL & VALIDATION

Attribute chart

discrete data classifying the number of items conforming and failing to conform to any specified requirements

P chart (fraction defective)

attribute chart example

Variable

actual records of numerical measurement on a full continuous scale.

X, R charts

example of variable

Stability

to determine the ability of a particular formulation in a specific container to remain within its physical, chemical, microbiological, therapeutic and toxicological specifications under defined environmental conditions

Shelf-life determination

the period of stability of the product, i.e. the time from the date of manufacture of the formulation until its chemical or biological activity is not less than 90% of the labelled potency or the lower limit of monograph specifications

Expiration date determination

it is the time in terms of month and year calculated from shelf-life + date of the last processing stage prior to packaging

30°C/75% RH

general conditions for long term stability testing in the ASEAN region are the Zone IVB conditions

I

Temperate climate

II

Subtropical and Mediterranean climate

III

Hot and dry climate

IVA

Hot and humid climate

IVB

Hot and very humid climate

Overage

voluntary introduction of a specific excess of active

Manufacturing overage

added to compensate for loss during product manufacture

Stability overage

added to extend product shelf-life

30%

vitamins

15%

dry dosage forms

20%

fluids

25%

ointments, suppositories, aerosols, creams and foams

Validation

verification, by data analysis, that the design objectives of a given facility, system, apparatus, or procedures are reliably fulfilled in routine operation

Process Validation

gathering and documenting of sufficient evidence to give reasonable assurance that the process under review does what it purports and is expected to do

Concurrent

validation carried our during development stage on the basis of risk analysis of the production process

Prospective

prospective

Retrospective

comprehensive review of historical data to provide documented evidence that the process is doing what it is believed to do

Assay validation

process by which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements of the intended analytical applications

gross, random, systematic

Assay source of errors

% relative error (E)

expressed by accuracy

2.0%

limit of error in accuracy; limit of relative deviation

Accuracy

closeness of the results to the true value

Precision

agreement among repeated measurements; expressed as relative standard deviation or RSD (COV); measure of reproducibility

Limit of quantitation

lowest concentration of analyte in a sample that can be determined with acceptable precision and accuracy; standard deviation multiplied by 10

Selectivity/Specificity

ability to measure accurately and specifically the analyte in the presence of other components

Linearity

ability to elicit test results that are directly proportional to the concentration of analyte in sample within a given range

Terms of variance and slope

linearity expression on the regression line

Range

the interval between the upper and lower levels of the analyte

Ruggedness

degree of reproducibility of test results obtained by the analysis of the same samples under a variety of normal test conditions

Validation of existing products

related to the efficiency of the product (potency, content uniformity, dissolution/bioavailability)

Cleaning validation

utilize instruments that can detect microgram levels of contaminants from product and detergent residues