QC

Process validation

the analysis of data gathered throughout the design and manufacturing of a product

Process Validation

ensure that the varied inputs lead to consistent and high quality outputs

Process Design

the commercial manufacturing process is defined during this stage based on the knowledge gained through development and scale-up activities

Process Qualification

during this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing

Continued Process Verification

an ongoing assurance gained during routine production to assure that the process remain in a state of control

Assay validation

the process of demonstrating that the analytical procedures are suitable for their intended use

Accuracy

the closeness of agreement between values

Precision

express the closeness of agreement between a series of measurements from multiple sampling of the same homogeneous sample under prescribed conditions

Repeatability

express the precision under the same operating conditions over a short interval of time

Reproducibility

express the precision between laboratories

Specification

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

Detection limit

the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value

Quantitation limit

the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy

Linearity

has the ability to obtain test results which are directly proportional to the concentration of the analyte in a sample

Range

the interval between upper and lower concentrations of the analyte in a sample

Robustness

has the capacity to remain unaffected by small but deliberate variations in method parameters

Ruggedness

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

Sensitivity

refers to it being equal to the slope of the calibration line in a linear system

Qualification

a pre-requisite of validation

Design Qualification

the principles of this design should be such as to achieve the objectives of GMP with regard to equipment

Installation Qualification

this should be carried out on new or modified facilities, systems and equipment

Operational Qualification

a qualification element where tests are developed from the knowledge of the processes systems and equipments

Performance Qualification

a qualification element that tests using production materials, substitutes, or stimulated product

Spectrometry

method of analysis which deal with the measurement of spectra, power, transmitted, fluorescent, reflected or emitted energy

Spectrophotometry

A branch of spectrometry that measures the absorption by chemical species of radiant energy of definite and narrow wavelength

Electromagnetic spectrum

the complete system of energy propagated in the wave form

Colorimetric

the visible region of the spectrum

Radiant energy

the energy transmitted through electromagnetic waves

Wavelength

the length of a complete wave or cycle

Wavenumber

the number of waves per centimeter and is equal to 1 wavelength (cm)

Frequency

the number of complete cycles which pass a given point per second

Chromophore

a functional group that absorbs radiant energy in the UV or visible regions of the spectrum

Electromagnetic spectrum

a form of energy which is transmitted through a space at enormous velocities and gives colors

Optical methods

spectrochemical methods that only utilize UV/visible light and infrared

Electric field

a vector whose length is proportional to the field strength

Emission spectroscopy

refers to the methods in which the stimulus is heat or electrical energy

Chemiluminescence spectroscopy

refers to the excitation of the analyte by a chemical reaction

absorption spectroscopy

measures the amount of light absorbed as a function of wavelength

photoluminescence spectroscopy

the emission of photons is measured following absorption, its most important forms are fluorescence and phosphorescence spectroscopy

UV/Visible Spectroscopy

the absorption spectroscopy or reflectance spectroscopy in the ultra-violet-visible spectra region

Wavelength selector

it utilizes monochromators or polychromators to isolate a specific wavelength in the instrument

Nuclear Magnetic Resonance (NMR) Spectroscopy

an analytical chemistry technique for determining the content and purity of a sample as well as its molecular structure

Mass spectroscopy

it determines the identity of unknown compounds

Atomic mass spectrometry

it can determine nearly all the elements in the periodic table

Molecular mass spectrometry

it is capable of providing information about the structures of inorganic, organic, and biological molecules

mass spectrum

the ion abundance plotted against mass-to-charge ratio

Flame Photometer

an instrument used in detecting alkali, alkaline earth metals, lead in petrol, and Ca and Mg in cement

Inductively Coupled Plasma

an instrument used to detect and quantify elements in a sample

Atomic Absorption Spectroscopy

an instrument used in food, water, and clinical analysis, as well as additives in lubricating oils and greases

UV-VIS

an instrument used to detect geometrical isomers, functional groups, impurities, and in qualitative and quantitative analysis

Light-scattering

an instrument used in the analysis of macromolecules and molecular weight determination

Spectrometry

an instrument used in the analysis of air pollution and diffusion phenomena

Infrared

an instrument used to check for the identity of raw materials, in fingerprint testing, and detection of polymorphs of drugs

Infrared

an instrument used in the synthetic chemistry as a preliminary check for compound identity and in the characterization of samples in the solid and semi-solid states

Mass spectroscopy

an instrument used in the pharmaceutical, forensic and environmental analysis, and in the biomolecule characterization

Quality control

a series of analytical measurements used to assess the quality of the analytical data; “the tools”

Quality assurance

an overall management plan to guarantee the integrity of data; “the system”

Quality control

a process employed to ensure a certain level of quality in a product or service

Quality assurance

ensures public recognition and credibility through the maintenance of standards

Specifications

defined as a list of tests, references to analytical procedures and appropriate acceptance criteria which are numerical limits, rangers, or other criteria for tests described

Specifications

establishes a set of criteria to which a drug substance, a drug product or materials at other stages of manufacture should conform to be considered acceptable for their intended use

Formula

a concise and precise statement of the ingredients with percentage and accurate weights

Raw Material Specification

enumerates the characteristics of all material that go into a product and the permissible range of purity of each ingredient

Standard Operating Procedure (SOP)

a step by step method on how to go about a job and must contain instructions and information that assure variations in productions within acceptable established range

Finished Product Specification

it covers the characteristics that affect the proper performance, purity, safety, and stability of the product

Packaging Material Control

the information shall be provided to the construction of the container, with a list of different components, the type of material used in diff parts and the nature of the polymers

Defect

occurs when a product departs from its intended design and is more dangerous than consumers expect their product to be

Variable defect

can be measured directly by instruments

Attributive defect

cannot be measured directly by instruments and shows mainly conformance and nonconformance

Critical defect

kind of defect that may endanger life or property and may render the product useless or non-functional

Major defect

a kind of defect that can affect the function of the object and may render the product useless

Minor defect

a kind of defect that doesn’t endanger life or property and will affect the function but still a defect since it is outside the prescribed limit

Critical defects

Birds swings

Critical defects

Spikes

Critical defects

Overpress

Critical defects

Filament

Critical defects

Check

Critical defects

Poor distribution

Critical defects

Soft blister

Critical defects

Pinholes

Critical defects

Chipped finish

Birds swings

a glass thread joining the two walls of the container

Spikes

glass projections inside the bottle

Overpress

a finish which has excessive glass projecting upward from the edge of the finish

Filament

a hair-like string inside the bottle

Check

a crack or fracture through the wall thickness in the body of container

Poor distribution

uneven wall thickness or under height exceeding or is below specifications

Soft blister

a thin walled bottle in the glass

Pinholes

any opening causing leakage and occurs most often in bottles with pointed corners

Chipped finish

a small section is broken on the top or side of a bottle

Major defect

Stone

Major defect

Rocker bottom

Major defect

Mismatch

Major defect

Out of round finish

Stone

small pieces of refractory of unmelted batch materials

Rocker bottom/Sunken

part of the bottle that became sagged making container unstable when placed on flat surface

Mismatch

when the two halves of the neck ring are offset to each otherOu

Out of round finish

a finish which is oval-shaped and which may be pinched or flattened

Minor defect

Sunken

Minor defect

Tear