Lesson 1 Flashcards
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
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)
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)
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
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)
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
mainly used to quantify any compound in the sample or to determine the amount of each compound present in the sample.
Technique of Analysis
Samples of Technique Analysis
Proximate Analysis
Partial Analysis
Trace Constituent Analysis
Complete Analysis
Methods of Analysis
Chemical Method
Electrical Method
Instrumental Method
Chromatographic Method and Electrophoretic Method
Biological and Microbiological Method
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
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
this device enables the selection of relatively narrow bonds of wavelengths from a broad brand of radiation.
Wavelength Selector
prevent the passage of radiation at all wavelengths except in a fixed wavelength region.
Filters
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
It is used routinely to monitor in vitro release of active ingredients from formulations.
UV Spectrophotometry
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
Has the potential to replace chromatography as a method for m more rapid analysis of multicomponent samples.
NIR Spectrometry
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
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
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
Radiation in the wavelength passed through a solution of a compound ranges from?
200-700 nm
relationship between absorbance, concentration, and path length is described, which states that absorbance is directly proportional to concentration and path length.
Beer-Lambert Law
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
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
API
Active Pharmaceutical Ingredient
BE
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.
