Lesson 1 Flashcards by Marianne Nadeen Aini Tupay

Addresses the requirements for control of the quality of methods of analysis (validation)and registration of the pharmaceuticals for Human Use

Standardized the requirements of medicine regulation.

International Conference on Harmonisation (ICH) Guideline

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facilitates access to quality-assured, safe and effective health products by assessing medicines, vaccines and medical devices for priority diseases, while working to fight the growing issue of antibacterial resistance.

World Health Organization (WHO)

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Leading the international development, implementation and maintenance of harmonised GMP standards and quality systems of Inspectorates in the field of medicinal products.

Pharmaceutical Inspection Co-Operation Scheme (PIC/s)

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provide assistance to each other in the form of training and research facilities in the educational, professional, technical and administrative spheres.

Brunei Darussalam, Burma, Cambodia, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand, and Vietnam

Association of SouthEast Asian Nations

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an independent, non-governmental international organization with a membership of 170 national standards bodies.
- International standards ensure that the products and services you use daily are safe, reliable, and of high quality.

International Organization for Standardization (ISO)

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provides an exact description of how the analysis is carried out. It should describe in detail the steps necessary to perform each analytical test.

Analytical Procedure

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mainly used to quantify any compound in the sample or to determine the amount of each compound present in the sample.

Technique of Analysis

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Samples of Technique Analysis

Proximate Analysis
Partial Analysis
Trace Constituent Analysis
Complete Analysis

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Methods of Analysis

Chemical Method
Electrical Method
Instrumental Method
Chromatographic Method and Electrophoretic Method
Biological and Microbiological Method

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used to determine the concentration of components in the sample.

Employed to measure physical properties of substances like absorbance, transmittance, fluorescence, etc.

Instrumental Method of Analysis

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study of the interaction of LIGHT/EMR with matter.

Involves the measurement of the amount of EMR that is absorbed, emitted, or scattered by a sample to perform an assay.
Quantitative in nature

Spectroscopy

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this device enables the selection of relatively narrow bonds of wavelengths from a broad brand of radiation.

Wavelength Selector

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prevent the passage of radiation at all wavelengths except in a fixed wavelength region.

Filters

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one of the most widely used techniques in analytical chemistry, capable of producing accurate and precise results.

For these reasons, procedures using this technique are found in analytical, clinical, and research laboratories, and find extensive use in quality assurance.

UV and Visible Spectrophotometry

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It is used routinely to monitor in vitro release of active ingredients from formulations.

UV Spectrophotometry

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NIR radiation has good penetration properties and thus minimal sample preparation is required and thick sample layers can be used to compensate for the weakness of NIR absorption.

NIR Spectrometry

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Has the potential to replace chromatography as a method for m more rapid analysis of multicomponent samples.

NIR Spectrometry

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It is a very important and widely used sample characterization and analytical technique, whether the sample is in the form of a gas, a liquid, paste-like, or solid.

Mid IR Spectrometry

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a powerful method that can be applied to diverse biological problems.

Instruments illuminate samples with short wavelength light in the visible or ultraviolet wavelength regions.

Fluorescence Spectrometry

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is a technique used to analyze the absorption of light by molecules in the ultraviolet and visible regions of the electromagnetic spectrum.

UV and Visible Spectrophotometry

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Radiation in the wavelength passed through a solution of a compound ranges from?

200-700 nm

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relationship between absorbance, concentration, and path length is described, which states that absorbance is directly proportional to concentration and path length.

Beer-Lambert Law

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used to disperse the light into its constituent wavelengths, which are further selected by the slit.

It is rotated so that a range of wavelengths is passed through the sample as the instrument scans across the spectrum.

Monochromator

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designed to split the light beam so that the beam passes through two sample compartments, and, in such a double-beam instrument, a blank solution can then be used in one compartment to correct the reading or spectrum of the sample

OPTICS

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API

Active Pharmaceutical Ingredient

Bioequivalence

BCS

Classification System

Approval of a generic oral solid formulation of an API based on strictly defined dissolution criteria as a surrogate for an in vivo bioequivalence test (provided other aspects of the dossier are deemed acceptable according to the usual criteria).

Biowaiver

SUPAC

Scale-up and post-approval changes

It was proposed in 1995 by Amidon et al. It is a scientific framework which divides APIs into four groups, according to their solubility and permeability properties.

Biopharmaceutics Classification System

can be used to justify biowaivers for highly soluble and highly permeable drug substances (i.e., Class 1) in IR solid oral dosage forms that exhibit rapid in vitro dissolution using the recommended test methods.

Biopharmaceutics Classification Approach

high solubility - high permeability

BCS CLASS I

low solubility - high permeability

BCS CLASS II

high solubility - low permeability

BCS CLASS III

low solubility - low permeability

BCS CLASS IV

determining the earliest time at which the 95 percent confidence limit for the mean intersects the proposed acceptance criterion/ specification.

LINEAR REGRESSION

analysis of Covariance (ANCOVA)

Poolability test between batches

multi-factor, full- design studies

STATISTICAL MODELING

“trueness” of an analytical method, is the closeness of test results obtained by that method to the true or accepted reference value.

ACCURACY

degree of agreement among the individual test results by repeatedly applying that method to several replicates of the homogenous test samples.

PRECISION

same lab, same analyst, same equipment

REPEATABILITY OR INTRA ASSAY

measures the “among” and “within” lab. Precision

REPRODUCIBILITY

measures “within” lab precision of a single lab.

INTERMEDIATE PRECISION

ability of the method to produce test results that are proportional to the concentration of the analyte in the sample within a given range.

LINEARITY

the interval between the lower and the upper limits of the amount of the analyte providing sufficient accuracy and precision.

LINEAR RANGE

ability to assess unequivocally the analyte in the presence of components which may be expected to be present.

SPECIFICITY

the measure of its capacity to remain unaffected by small but deliberate changes in the method parameters.

ROBUSTNESS

Ways to Determine Accuracy

Reference Material Method Spiked Placebo Method Standard Addition Method Comparative Method Proficiency Testing Method

the ability of an active ingredient or a drug product to retain its properties within specified limits throughout its shelf-life.

STABILITY

consists of a series of tests in order to obtain an assurance of the stability of a drug product, namely maintenance of the specifications of the drug product packed in its specified packaging material and stored in the established storage condition within the determined time period.

STABILITY STUDY

This relationship is used to calculate the concentration of a substance in a sample based on its absorbance.

Beer-Lambert Law

the quantitative measurement of reflection or transmission properties

Spectrophotometry

Trace elements in trace constituent analysis

Copper, Zinc, Chromium, Iodine, Molybdenum, Cobalt, Selenium (100mg)

It has the highest electromagnetic radiation

Gamma Rays

It has the lowest electromagnetic radiation

TV/Radio Waves

instrumentation of spectroscopy that converts radiant energy to a measurable electrical signal

Detector

component of spectroscopic instruments that isolate a limited region of the spectrum of measurements

Wavelength isolator

FIVE COMPONENTS OF SPECTROSCOPIC INSTRUMENTS

Light Source Wavelength Isolator Sample Cell/Cuvette Detector Signal processing and Readout Unit

Radiation Sources/Light Source

Deuterium Lamp Hydrogen Lamp Tungsten Filament Lamp Xenon Arc Lamp

Methods of Quality System for the Analytical Laboratory

UV and Visible Soectrophotometry NIR Spectrometry Mid IR Spectrometry Fluorescence Spectrometry

EML

WHO Model List of Essential Medicines

HHS FDA

Department of Human Health: Federal Drug Agency, the United States of America

WHO working document QAS/04.093 entitled "Revision of multi-source (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability."

Multisource document

according to WHO, it is highly soluble when an API shows a dose/solubility ratio of

less than 250 ml at 37°C over a pH range of 1.2- 6.8

according to WHO, it is highly permeable when an API is absorbed to an extent of

85% or more.