Purity:

It is calculated by area normalisation method, it can be directly find out by chromatograms obtained
from HPLC.

% Purity = (Area of desired peak / Sum of area of all peaks) x 100

Assay:

It is calculated against standard. It may be of following types:

1) On as is basis = (Area of sample / Area of standard) x (conc. of standard / conc. of sample) x

potency or assay of standard
2) On anhydrous basis = (Assay on as is basis / 100 – moisture) x 100
3) On dried basis = (Assay on as is basis / 100 – LOD) x 100

Potency:

100 – (moisture or LOD + residual solvents + heavy metals + sulphated ash + impurities)

CALIBRATION

A calibration is a process that compares a known (the standard) against an unknown (the customer's
device). During the calibration process, the offset between these two devices is quantified and the
customer's device is adjusted back into tolerance (if possible). A true calibration usually contains
both "as found" and "as left" data.

VALIDATION
A validation is a detailed process of confirming that the instrument is installed correctly, that it is
operating effectively, and that it is performing without error. Because a validation must test all three
of these operational parameters, it is broken into three different tests: the installation qualification
(IQ), the operational qualification (OQ), and the performance qualification (PQ)

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Aseptic Processing
Processing conditions designed to achieve a sterile product.

Aseptic Processing Area

Area in which sterile product is formulated, filled into containers, and sealed.

Assay
A technique (test) for measuring a biological response or for determining characteristics such as
composition, purity, activity, and weight.

At Rest
HVAC room condition when unmanned, and without machinery operating. Previously called "static
condition".

Bactericide
An agent that kills vegetative bacteria but not mycobacteria or spores.

Bioactivity
A protein's ability to function correctly after it has been delivered to the active site of the body (in
vivo).

Bioassay
The determination of the biological activity of a substance (e.g. a drug) by observing its effect on an
organism (or organ) compared to a standard preparation

Bioequivalency
A scientific basis on which generic and brand name drugs are compared with one another. Drugs
are bioequivalent if they enter circulation at the same rate when given in similar doses under similar
conditions.

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Biological Indicators
Resistant microorganisms placed into or on various materials to confirm that a sterilization process is
effective. They may for instance be placed within a filter in order to determine if a proposed
autoclave cycle is effective. After autoclave, they are removed and culture tests are performed to
see if the microorganisms were killed.

Biological Safety Cabinets (BSCs)

Bench-top or freestanding cabinets with unidirectional airflow used for handling materials that
present a health hazard. The National Institutes of Health (NIH) Guidelines classify them as:

1. Class I - A negative pressure, ventilated cabinet for personnel protection having an inward
flow of air away from the operator. The exhaust air is filtered through a HEPA filter (located
at rear or top) either into the laboratory or to the outside. This cabinet is designed for general
microbiological research with low and moderate risk agents (BL-2 and BL-3 agents), and is
used in three operational modes:
a) With a full width open front. The face velocity of the inward flow of air through the full width
open front is at least 75' feet per minute.

b) With an installed front closure panel (having four 6-inch diameter openings) without
gloves. The face velocity of the inward flow of air through the openings will increase to
approximately 150' feet per minute.

c) With an installed front closure panel equipped with arm-length rubber gloves, and inlet air
pressure relief for further protection. In this configuration, it is necessary to install a make-up
air inlet fitted with a HEPA filter in the cabinet.

2. Class II - A ventilated cabinet for personnel and product protection having an open front
with inward airflow for personnel protection (75' to 100' feet per minute), and HEPA filtered
downward unidirectional airflow for product protection. The exhaust air is filtered through a
HEPA filter for environmental protection. For selection and procurement of Class II cabinets
refer to standards developed by the National Sanitation Foundation, Ann Arbor, Michigan.
Cabinets are further classified as:
a) Type A - Suitable for microbiological research in the absence of volatile or toxic chemicals
and radionuclides (BL-2 and BL-3), with 70% recirculated air through HEPA. They are
exhausted through HEPA into the laboratory or to the outdoors via a "thimble" connection to
the building exhaust system.

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 b) Type B - Hard ducted to the building exhaust system, contains negative pressure plena,
and face velocity of 100' feet per minute. Type B cabinets are further sub-typed into types:
B1 (30% recirculated air through HEPA; exhaust via HEPA and hard ducted. BL2 and BL-3),
B2 (No recirculation; total exhaust via HEPA and hard ducted. BL-2 and BL-3), and B3
(same as IIA, but plena under negative pressure to room and exhaust air is ducted. BL-2 and
BL-3).
Classes I and II should be located away from traffic patterns and doors, airflow from fans,
room air supply louvers, and other air moving devices.

3. Class III - Closed-front ventilated cabinet of gas tight construction that provides the highest
level of personnel protection from infectious aerosols, as well as protection of research
materials from microbiological contaminants. The interior of the cabinet is protected from
contaminants exterior to the cabinet. The cabinet is fitted with arm-length rubber gloves and
is operated under negative pressure of at least 0.5 inches water gauge. All supply air is
filtered through HEPA filters. Exhaust air is filtered through two HEPA filters in series or one
HEPA filter and incinerator before being discharged to the outside environment. Class III
cabinets are most suitable for work with hazardous agents that require Biosafety Level 3 or 4
containment. Cabinets must be connected to a double-door autoclave and/or chemical dunk
tank used to sterilize or disinfect all materials exiting the cabinet, and to allow supplies to
enter the cabinet.
Bioprocessing
The creation of a product utilizing a living organism.

Biosafety Level
The National Institutes of Health (NIH) specifies physical containment levels and defines Biosafety
Levels in their "Guidelines for Research Involving Recombinant DNA Molecules" - Appendix G - May
1999. There are four biosafety levels for operations performed with infectious agents:

1. BL1: Practices, safety equipment, and facilities appropriate for work performed with
defined and characterized strains of viable microorganisms not known to cause disease in
healthy adult humans. The Basic Laboratory. This laboratory provides general space in
which work is done with viable agents that are not associated with disease in healthy adults.
Conventional laboratory designs are adequate. Areas known to be source of general
contamination, such as animal rooms and waste staging areas, should not be adjacent to
patient care activities. Public areas and general offices to which non-laboratory staff requires
frequent access should be separated from spaces, that primarily support laboratory
functions.

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 2. BL2: Practices, safety equipment, and facilities appropriate for work performed with a
broad spectrum of moderate risk agents present and associated with human disease of
varying severity. The Basic Laboratory. This laboratory provides general space in which work
is done with viable agents that are not associated with disease in healthy adults.
Conventional laboratory designs are adequate. Areas known to be sources of general
contamination, such as animal rooms and waste staging areas, should not be adjacent to
patient care activities. Public areas and general offices to which non-laboratory staff requires
frequent access should be separated from spaces, which primarily support laboratory
functions.

3. BL3: Practices, safety equipment, and facilities appropriate for work performed with
indigenous or exotic agents where the potential for infection by aerosols is real and the
disease may have serious or lethal consequences. Just walking through the area and
breathing the air could infect one. The Containment Laboratory. This laboratory has special
engineering features that make it possible for laboratory workers to handle hazardous
materials without endangering themselves, the community, or the environment. The unique
features that distinguish this laboratory from the basic laboratory are the provisions for
access control and a specialized ventilation system. The containment laboratory may be an
entire building, a single module, or complex of modules within a building. In all cases, a
controlled access zone from areas open to the public separates the laboratory.

4. BL4: Practices, safety equipment, and facilities appropriate for work performed with
dangerous and exotic agents that pose a high individual risk of life-threatening disease.
Exposure to the skin could cause infection. The Maximum Containment Laboratory. This
laboratory has special engineering and containment features that allow activities involving
infectious agents that are extremely hazardous to the laboratory worker or that may cause
serious epidemic disease to be conducted safely. Although the maximum containment
laboratory is generally a separate building, it can be constructed as an isolated area within
the building. The laboratory's distinguishing characteristic is that it has secondary barriers to
prevent hazardous materials from escaping into the environment. Such barriers include
sealed openings into the laboratory, airlocks or liquid disinfectant barriers, a clothing-change
and shower room contiguous to the laboratory, a double door autoclave, a biowaste
treatment system, and a treatment system to decontaminate exhaust air.
(also see: Good Large Scale Practice, Containment Level, and Table II, Section II -
Comparison of Good Large Scale Practice (GLSP) and Biosafety Level (BL) - Large Scale
(LS) Practice)
Biotechnology
A process of applying genetic engineering (recombinant DNA), hybrid (monoclonal antibody),
hybridization (gene probes), bioelectric, etc. to commercial applications in pharmaceutical, chemical,
medical diagnostic device, food, animal and plant industries.
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BOD (Biochemical Oxygen Demand)
The amount of oxygen required to oxidize the dissolved organic matter in a water sample by aerobic
(bacterial) decay. A measure of the oxygen depletion that would result from discharging organic
impurities into a waterway.

BSE (Bovine Spongiform Encephalopathy)

Sometimes called "Mad Cow Disease". A disease of cattle presumably caused by a virus or other
unidentified entity that affects the brain and causes the cow to behave [Link] in parts
of Europe but not in the United States. BSE is a contaminant that is undesirable in bovine sera. It is
not known whether the causative agent can be filtered out since the causative agent itself is not
known. In humans, it is believed to cause Creutzfeld-Jacob, a disease affecting the nervous system.

Broth
The liquid culture medium in which fermentation or cell culture takes place.

Bubble Point Test

A filter leakage test in which the filter is wetted and air pressure is applied and slowly increased until
water is expelled from the largest pores and bubbles appear from a submerged tube in a
downstream collection vessel. Vigorous bubbling, as opposed to a diffusional airflow or occasional
bubbles, is indicative of reaching the bubble point. This visual test can be fairly accurate for low area
filters, such as discs. When used to evaluate high area filters, it is subject to limitations in
observation, test time, collection conditions, and pressurization rates. The bubble point test is not
recommended for integrity testing of filter cartridges.

Buffer
A substance capable of neutralizing both acids and bases in solution, thereby maintaining the
original acidity or causticity of the solution

Calorimetry
Analytical method that measures heat loss or gain resulting from physical or chemical changes in a
sample. Differential scanning calorimetry compares the results of heating a sample to those for
heating a reference material. For example, a method to measure the temperature at which the
sample crystallizes, changes phases, or decomposes.

Carcinogen
A substance that causes the development of cancerous growths in living tissue. A chemical is
considered to be a carcinogen if it has been evaluated by the International Agency for Cancer
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Research (IARC) and found to be a carcinogen or potential carcinogen, or if it is listed in the Annual
Report on Carcinogens published by the National Toxicology Program, or if it is regulated by OSHA
as a carcinogen.

CFR (Code of Federal regulations) Title 21

The U.S. regulations that directly apply to biopharmaceutical development are contained in Title 21
parts 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), 210 (Current Good
Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General), 211
(Current Good Manufacturing Practice for Finished Pharmaceuticals), and 600 (Biological Products:
General).
Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 312 (Investigational
New Drugs) apply to critical trials.
Part 11 provides criteria which will consider electronic records to be equivalent to paper records and
electronic signatures to be equivalent to traditional handwritten signatures. (also see: cGMPs
(current Good Manufacturing Practices))

CFU (Colony Forming Unit)

A measure of the number of bacteria present in the environment or on the surfaces of an aseptic
processing room, measured as part of qualification and ongoing monitoring. Also applied to the
testing of purified water samples.

cGMPs (current Good Manufacturing Practices)

Current accepted standards of design, operation, practice, and sanitization. The FDA is empowered
to inspect drug-manufacturing plants in which drugs are processed, manufactured, packaged, and
stored for compliance with these standards.

Change Control
A formal system by which qualified representatives of appropriate disciplines review proposed or
actual changes that might affect a validated process's status. The intent is to determine the need for
action that would ensure that the system is maintained in a validated state.

CIP (Clean In Place)

Internally cleaning a piece of equipment without relocation or disassembly. The equipment is
cleaned but not necessarily sterilized. The cleaning is normally done by acid, caustic, or a
combination of both, with WFI rinse. The design of a CIP system should considered the operating
volume design for the water consumption, chemical and biowaste effluent, and energy required to

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clean a given circuit or piece of equipment.

Class 100
Classification of an aseptic processing area where particle count should not exceed 100 particles
(3,530 particles per cubic meter) 0.5µm or larger, per cubic foot of air, and no more than 0.1 CFU
(Colony Forming Units) per cubic foot. Target uniform air velocity is 90 fpm plus or minus 20%,
HEPA filtered air. (also see Table I, Section II - Comparison of Airborne Particulate Cleanliness
Classes)

Class 1,000
Classification of an area where particle count should not exceed 1,000 particles (35,300 particles per
cubic meter) 0.5µm or larger, per cubic foot of [Link] by HEPA filtered air. Class 1,000 is not a
pharmaceutical GMP expectation. (also see Table I, Section II - Comparison of Airborne Particulate
Cleanliness Classes)

Class 10,000
Classification of an area where particle count should not exceed 10,000 particles (353,000 particles
per cubic meter) 0.5µm or larger, per cubic foot of air. Minimum of 20 air changes per hour, HEPA
filtered air. (also see Table I, Section II - Comparison of Airborne Particulate Cleanliness Classes)

Class 100,000
Classification of an area where particle count should not exceed 100,000 particles (3,530,000
particles per cubic meter) 0.5µm or larger, per cubic foot of air, and no more than 2.5 CFU (Colony
Forming Units) per cubic foot. Minimum of 20 air changes per hour of HEPA filtered air. (also see
Table I, Section II - Comparison of Airborne Particulate Cleanliness Classes)

Class Name
"For naming and describing the classes, SI names and units are preferred; however, English (U.S.
customary) units may be used". Federal Standard 209E superseded by ISO 14644-1). (also see
Table I, Section II - Comparison of Airborne Particulate Cleanliness Classes)

Cleanroom
A specially constructed space environmentally controlled with respect to airborne particles (size and
count), temperature, humidity, air pressure, airflow patterns, air motion, and lighting. ISO 14644-1
defines it as "a room in which the concentration of airborne particles is controlled, and which is

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constructed and used in a manner to minimize the introduction, generation, and retention of particles
inside the room, and in which other relevant parameters, e.g. temperature, humidity, and pressure,
are controlled as necessary." (also see Table I, Section II - Comparison of Airborne Particulate
Cleanliness Classes)

COD (Chemical Oxygen Demand)

The amount of oxygen needed to completely oxidize all oxidizable organic and inorganic substances
in water.

Colony
A growth of microorganisms on a solid medium. The growth is visible without magnification.

CMC (Chemistry, Manufacturing, and Controls)

The section on a BLA (Biologics License Application) or IND (Investigational New Drug) describing
the composition, manufacture, and specifications of a drug product and its ingredients.

Conductivity
The reciprocal of resistivity (C=1/R). A measure of the ability to conduct an electric current. Since
ionized impurities increase the conductivity of water, it is also an accurate measure of ionic purity.
Conductivity is normally expressed in micromhos/cm (µmho/cm) or microsiemens/cm (µS/cm). To
measure it, current is passed between two electrodes a fixed distance apart.

Controlled Area
An area constructed and operated in such a manner that some attempt is made to control the
introduction of potential contamination, and the consequences of accidental release of living
organisms. The level of control exercised should reflect the nature of the organism employed in the
process. At a minimum, the area should be maintained at a pressure negative to the immediate
external environment and allow for the efficient removal of small quantities of airborne
contaminants.

Cross Contamination
The measurable and detrimental contamination of a material or product with another material or
product.

Dead Leg
An area of entrapment in a vessel or piping run that could lead to contamination of the product. In a
piping system, a non-flowing pocket, tee, or extension from a primary piping run that exceeds a

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defined number of pipe diameters from the ID of the primary pipe. Denoted by the term L/D or L/A,
where L is equal to the leg extension perpendicular to the normal flow pattern or direction, A is the
annular gap width, and D is equal to the ID (or inside dimension) of the extension or leg. In some
existing standards, the dimension L is measured from the centerline of the primary pipe. For
bioprocessing systems, an L/D of 2:1 is achievable with today's component technology for most
valving and piping configurations.

Depyrogenation
The removal or destruction of endotoxins.

Desiccators
Closed containers, usually made of glass or plastic, with an airtight seal used for drying materials.

Disinfection
Process by which viable microbiological agents or eukaryotic cells are reduced to a level unlikely to
produce disease in healthy people, plants, or animals. These processes may use chemical agents,
heat, ultraviolet light, etc. to destroy most (but not necessarily all) of the harmful or objectionable
microorganisms, pathogens, and potential pathogens. Disinfection does not necessarily result in
sterilization

Distillation
The process of separating water from impurities by heating until it changes into vapor and then
cooling the vapor to condense it into purified water.

DOP (Dioctyl Phthalate)

A mono-dispersed test aerosol of sub-micron particles, generated to challenge (evaluate integrity) of
HEPA filters for HVAC.

Dry Heat Sterilization

Sterilization utilizing a heating oven or continuous tunnel (gas or electric heated), as opposed to
steam sterilization in an autoclave, usually used for glassware and metal parts. In depyrogenation
temperatures of 250ºC result in sterilization and the inactivation of endotoxin present on the surface
of the equipment.

Electrophoresis
The migration of electrically charged proteins, colloids, molecules, or other particles when dissolved
or suspended in an electrolyte through which an electric current is passed. The most important use

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of electrophoresis is in the analysis of blood proteins. Since the proportion of these proteins varies
widely in different diseases, electrophoresis can be used for diagnostic purposes. Electrophoresis is
used to study bacteria and viruses, nucleic acids, and some types of smaller molecules, including
amino acids.

ELISA (Enzyme Linked Immunosorbent Assay)

A test to measure the concentration of antigens or antibodies.

Endotoxin
A poisonous complex molecule (lipopolysaccharide) that forms an integral part of the bacterial
(gram-negative bacteria) cell wall and is only released when the integrity of the wall is disturbed.
Certain organisms may release endotoxins (e.g. E. coli) during biosynthesis of a recombinant DNA
product, thus necessitating purification steps to ensure their removal. In water treatment, it most
often refers to pyrogens.

EPO (Erythropoietin)
A glycoprotein hormone that stimulates the production of red blood cells. It is a commercialized
product of recombinant DNA technology.

Epoxy
These materials are based on the reactive oxirane group, which are characterized by the attachment
of one oxygen atom to two different adjacent carbon atoms. Standard epoxy resins are the reaction
product of bisphenol A and epichlorohydrin. Curing of epoxy resins generally occurs at ambient
temperatures and is achieved by the chemical reaction of the epoxy with a second reactant such as
amines, polyamines, amine products, or other reactants. Cure can occur at higher temperatures
when reacted with anhydrides, carboxylic acids, phenol or novolac (phenol-formadehyde)
thermoplastic resins. These reactants are sometimes referred to as catalysts, which is a misnomer.

Filtration
Removal of suspended matter from a fluid by passing it through a porous matrix that prevents
particles from getting through, usually by entrapment on or in the filter matrix.

Fluidized Bed
A container holding powder coating material which is aerated from below so as to form an air-
supported expanded cloud of such material through which the preheated object to be coated is
immersed and transported.

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Generic Drug
A drug produced and marketed under its chemical or "generic" name (e.g. acetaminophen) as
opposed to "Tylenol", a brand name for the former produced by Johnson & Johnson. A generic drug
can be sold only after a proprietary drug goes off patent (i.e. when the patent runs out after 17
years). There are numerous generic drug manufacturers. While generic drugs are cheaper for
consumers, they still must meet the standards of GMPs as set out by the FDA.

Germicide
An agent that destroys microorganisms, especially pathogenic microorganisms ("germs").Sterilants,
disinfectants, and antiseptics are germicides

Heavy Metals
High molecular weight metal ions, such as lead. Known for their interference with many processes,
and "poisoning" of catalysts, membranes, and resins.

HEPA (High Efficiency Particulate Air) Filters

Filters with a minimum efficiency of 99.97% for 0.3µm particle size as determined by test. The test
can be by the monodisperseddioctyl phthalate (DOP) method or other equally sensitive method.
When operated at design velocity, larger and smaller particles are captured at higher efficiencies.
HEPA filters are made of compressed and bonded micro-fiberglass or Teflon® corrugated to
produce a high surface area in a small area panel of filter medium. Employed in unidirectional airflow
benches, air handlers, and as terminal air supply filters in cleanrooms.

HPLC (High Pressure Liquid Chromatography)

Sometimes called high-performance liquid chromatography, is a separation technique based on a
solid stationary phase and a liquid mobile phase. Separations (into distinct bands) are achieved by
partition, adsorption, or ion-exchange processes, depending upon the type of stationary phase used.
Each band is then profiled as the solvent flows through a UV detector, or by fluorescence, or
refractive index detectors.

Hydrolysis
A chemical reaction between water and organic compounds, particularly esters, ketones, and
alcohols. This reaction can lead to breakdown of some proteins.

LAL (Limulus Amoebocyte Lysate)

A material obtained by rupturing the cellular components of the blood of a horseshoe crab (Limulus

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Poliphemus). This material coagulates in the presence of LPS (lypopolysaccharides) and is a test
used to quantitate bacterial endotoxins (pyrogens).

Laminar Flow
Non-turbulent fluid flow is usually considered laminar if the Reynolds number is less than 2000 in a
pipe. Depending upon many possible varying conditions, the flow may be laminar at a Reynolds
number as low as 1,200 or as high as 40,000; however, such conditions are not experienced in
normal practice. In the pharmaceutical industry, this term incorrectly refers to the air discharge of a
clean air bench or wall.

Lipids
Hydrophobic biological compounds (fats and fatlike materials) that are insoluble in water, but soluble
in nonpolar solvents such as benzene, chloroform, and ether. The major components in most lipids
are fatty acids.

Lipoprotein
A conjugated protein containing a lipid, prosthetic group.

Liposome
An artificial phospholipid vesicle. Liposomes can be useful for the enclosure of macromolecules such
as nucleic acids or, after loading with an appropriate drug. They may be used therapeutically to
achieve slow release of the drug into circulation.

Lyophilization
Also known as freeze drying, it is a means of stabilizing wet substances by freezing them, then
evaporating the resulting ice, to leave a substantially dry, porous residue which has the same size
and shape of the original frozen mass.

Manufacturing Process
All manufacturing and storage steps in the creation of the finished product from the weighing of
components through the storing, packaging, and labeling of the finished product, including, but not
limited to, the following: Mixing, granulating, milling, molding, formulating, lyophilizing, tableting,
encapsulating, coating, sterilizing, and filling

Medicinal Product
Any substance or combination of substances presented for treating or preventing disease in human

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beings or animals. Any substance or combination of substances that may be administered to human
beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying
physiological functions in human beings or in animals is likewise considered a medicinal product.

Methods Validation
Establishing, through documented evidence, a high degree of assurance that an analytical method
will consistently yield results that accurately reflect the quality characteristics of the product tested.

Molecular Weight
The weight of a molecule that may be calculated as the sum of the atomic weights of its constituent
atoms. Atomic weight is the weight of an element in relation to some element taken as the standard,
usually oxygen (16) or carbon (12).

MSDS (Material Safety Data Sheet)

Document describing the chemical and physical properties of a substance as related to its safe
handling and storage. The substance manufacturer originates it.

Nephelometer
Any apparatus used to measure the size and concentration of particles in a liquid by analysis of light
transmitted through or reflected by the liquid.

Ozone
Formed by an electric discharge or by the slow combustion of phosphorus, ozone is a modified and
condensed form of oxygen, in which three atoms of oxygen are combined to form the molecule, O3.
Because it is a powerful oxidizing agent it is used in deionized water systems to kill bacteria and to
reduce by oxidation the amount of Total Organic Carbon (TOC) in the water. Air containing a
perceptible amount of ozone has an odor suggesting chlorine or sulfurous acid gas.

Parenteral Drug (LVP, SVP)

A parenteral drug is defined as one intended for injection through the skin or other external boundary
tissue, rather than through the alimentary canal, so that active substances they contain are
administered, using gravity or force, directly into a blood vessel, organ, tissue, or lesion. They are
infused when administered intravenously (IV), or injected when administered intramuscularly (IM), or
subcutaneously into the human body. A large volume parenteral (LVP) is a unit dose container of
greater than 100ml that is terminally sterilized by heat. Small volume parenteral (SVP) is a "catch-all"
for all non-LVP parenterals products except biologicals.

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Particle
Solid or liquid object which for purposes of classification of air cleanliness, falls within a cumulative
distribution that is based upon a threshold (lower limit) size in the range from 0,1 µm to 5 µm. ISO
14644-1

Particle Size
The apparent maximum linear dimension of a particle in the plane of observation as seen with a
microscope or the equivalent diameter of a particle detected by automatic instrumentation. The
equivalent diameter is the diameter of a reference sphere having known properties and producing
the same response in the sensing instrument as the particle being measured. ISO 14644-1

Pathogen
Any microbiological or eukaryotic cell containing sufficient genetic information, which upon
expression of such information is capable of producing disease in healthy people, plants, or animals.

pH
The pH value of an aqueous solution is a number describing its acidity or alkalinity. A pH is the
negative logarithm (base 10) of the concentration of hydrogen ions (equivalent per liter). The pH
value of a neutral solution is 7. An acidic solution has a pH less than 7, while a basic solution has a
pH greater than 7, up to 14.

Polymerase Chain Reaction (PCR)

A method for amplifying a DNA base sequence using a heatstable polymerase and two 20-base
primers, one complementary to the (+) strand at one end of the sequence to be amplified and the
other complementary to the (-) strand at the other end. Because the newly synthesized DNA strands
can subsequently serve as additional templates for the same primer sequences, successive rounds
of primer annealing, strand elongation, and dissociation produce rapid and highly specific
amplification of the desired sequence. PCR also can be used to detect the existence of the defined
sequence in a DNA sample.

PPM (Parts Per Million)

The most common measure of dissolved ionized impurities in water. It is the same as milligrams per
liter. For discussion of ppm as a measure of Total Ionized Solids see Milliequivalent.

PQ (Performance Qualification)
Documented evidence that a process or system consistently and reproducibly performs as intended

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and does what it purports to do. This accomplished through extended time studies or process runs
with simulated products or conditions.

PTFE (Polytetrafluoroethylene) Teflon®

Afluoroplastic that is resistant to practically every known chemical or solvent in combination with the
highest useful temperature limit of commercially available plastics. PTFE has a melt point of 620°F
(327°C), a useful temperature range from -436°F (-260°C) to 500°F (260°C), high impact strength,
and exceptionally low coefficient of friction. Usual processing techniques like injection molding are
not possible with PTFE due to a very high molecular weight which results in a melt viscosity about 1
million times higher than is acceptable for conventional thermoplastics. PTFE resin is pressed into
shapes under high pressure at room temperature and then heated to 700°F (371°C) to complete the
molding (sintering process) and adjust the crystalline content.

Purified Water, U.S.P.

Water rendered suitable for pharmaceutical purposes by processes such as distillation, ion-
exchange treatment (deionization or demineralization), or reverse osmosis. It meets rigid
specifications for chemical purity, the requirements of the Federal Environmental Protection Agency
(EPA) with respect to drinking water, and it contains no added substances. Cannot be used as raw
material for parenterals. Common uses are: a rinse for equipment, vials, and ampoules, and as
make up for cosmetics, bulk chemicals, and oral products. For FDA acceptance, purified water must
contain less than 0.5 mg/l of TOC (Total Organic Carbon), and less than 100 CFU (Colony Forming
Units).

QA (Quality Assurance)
The sum total of the organized arrangements made to ensure that all APIs (Active Pharmaceutical
Ingredients) are of the quality required for their intended use and that quality systems are
maintained.

QC (Quality Control)
Checking or testing, that specifications are met, or the regulatory process through which the industry
measures actual quality performance, compares it with standards, and acts on the difference.

Qualification
Action of providing that equipment or ancillary systems are properly installed, work correctly, and
actually lead to the expected results. Qualification is part of validation, but the individual qualification
steps alone do not constitute process validation.

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Radio-Immunoassay (RIA)
A highly sensitive method of detecting and measuring the concentration of biological compounds in
vivo

Recovery Time
The time after an upset in a room's HVAC environmental parameters for the room to return to
"normal" conditions, such as a return to acceptable humidity levels after a room wash down. This
occurs within a certain number of air changes after the upset source is removed, minimally six to ten,
depending on the severity of the upset, the quality of the air supply, and the degree of mixing of
room air.

Reference Standard, Primary

A substance that has been shown by an extensive set of analytical tests, to be authentic material of
high purity. This standard may be obtained from a recognized source or may be prepared by
independent synthesis or by further purification of existing production material

Regulatory Affairs
Drug companies must show that their products consistently meet standards set by government
agencies. Regulatory affairs departments document those activities, submit proposals, and follow
those proposals through completion or approval.

Relative Humidity (% RH)

The ratio (measured in percent) of actual water vapor pressure in air to the pressure of saturated
water vapor in air at the same temperature and pressure

Reprocessing
A system of reworking batches that do not conform to standards or specifications, including "the
steps taken to ensure that the reprocessed batches will conform to all established standards,
specifications, and characteristics".

Reprocessing (ICH API definition)

Introducing an intermediate or API, including that which does not conform to standards or
specifications, back into the process and repeating a crystallization step or other appropriate
chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling, etc.) that
are part of the established manufacturing process. Continuation of a chemical reaction after an in-

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process control test shows the reaction to be incomplete is considered to be part of the normal
process, and not reprocessing.

Retest Date
The date when samples of the API (Active Pharmaceutical Ingredient)a material should be re-
examined to ensure that material is still suitable for use.

Reverse Osmosis (RO)

The reversal of osmosis to purify water. In osmosis, water diffuses through a semipermeable
membrane from a region of higher concentration (such as pure fresh water) into one of lower
concentration (such as a solution of water and salt). The flow of water can be reversed with an
opposing pressure that exceeds osmotic pressure. With RO, water is forced out of the lower
concentrated solution (such as the salt solution), leaving the solute (impurities) behind.

Saponification
Alkaline hydrolysis of triacylglycerols to yield fatty acids as soaps

Sensitizer
A chemical that causes a substantial proportion of exposed people or animals to develop an allergic
reaction in normal tissue after repeated exposure to the chemical.

Sepsis
The presence of various pus-forming and other pathogenic organisms or their toxins in the blood or
tissues; septicemia.

Solvent
An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the
manufacture of an intermediate or API (Active Pharmaceutical Ingredient).

SOP (Standard Operating Procedures)

The description of necessary activities to respond to normal and abnormal situations in an operating
system. The SOP may include a troubleshooting checklist, list of personnel to contact, etc. SOPs
should also describe normal operation, maintenance, and cleaning of the system, and normal
operating parameters. An SOP may be created for any system but an SOP must be created for each
system requiring qualification.

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Specification
A list of testes, references to analytical procedures, and appropriate acceptance criteria that are
numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to
which an intermediate or API (Active Pharmaceutical Ingredient) should conform to be considered
acceptable for its intended use. "Conformance to Specifications" means that the intermediate or API,
when tested according to the listed analytical procedures, will meet the listed acceptance criteria

Stability
Generally, stability refers to the physico-chemical condition of a parenteral, biological, or shelf life of
labile drugs. Certain drugs must pass U.S.P. or CFR stability tests. For example, human serum
albumin must pass certain limits of nephelometric turbidity. Also manufacturers must have
documentation of potency of labile products under labeled storage conditions.

Sterile Water
For Injection, U.S.P. A form in which water is distributed in sterile packages. Sterile Water for
Injection is intended mainly for use as a solvent for parenteral products such as sterile solids that
must be distributed dry because of limited stability of their solutions. It must be packaged only in
single-dose containers of not larger than 1-liter size.

Sterilization
The act or process, physical or chemical, that destroys or eliminates all viable microbes including
resistant bacterial spores from a fluid or a solid. Despite being stated as an absolute, the action of
sterilization is usually stated in terms of probability. Examples of sterilization methods are: steam
treatment at 121°C, dry heat at 450°F, flushing with a sterilizing solution such as Hydrogen Peroxide
(H2O2) or ozone (O3), irradiation, and filtration.

Steroids
Classified as lipids, naturally occurring steroids are hormones that are important regulators of animal
development and metabolism at very low concentrations. A well known steroid, cholesterol, is
present in membranes of animal tissues. Other steroids include testosterone (a male sex hormone),
cortisone (an adrenocortical hormone), estrone (a female sex hormone), and progesterone.

Strength
The concentration of the drug substance (for example, weight/weight, weight/volume, or unit
dose/volume basis), and/or the potency, that is, the therapeutic activity of the drug product as

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indicated by appropriate laboratory tests or by adequately developed and controlled clinical data
(expressed, for example, in terms of units by reference to a standard).

Supernatant
The material floating on the surface of a liquid mixture (often the liquid component that has the
lowest density).

Surfactant
Any substance that changes the nature of a surface, such as lowering the surface tension of water.

Terminal Sterilization
The process applied to product sealed in its final container that transforms a non-sterile product into
a sterile one.

Terminal Sterilization
This term is a gross misnomer because it refers specifically to the terminal heat sterilization of LVPs
usually by steam

Theoretical Yield
The quantity that would be produced at any appropriate phase of manufacture, processing, or
packing of a particular drug product, based upon the quantity of components to be used, in the
absence of any loss or error in actual production.

Topical Product
A pharmaceutical product meant to be applied to the skin or soft tissue in the form of liquid, cream,
or ointment, and therefore needs not be aseptic. Sterile ophthalmic products throughout are
manufactured aseptically.

Total Organic Carbon (TOC)

A measure of the level of organic impurities in water by their carbon content that determines the
operating life of activated carbon beds. This is one of the parameters used to determine the purity of
Semiconductor Grade water. Feed water will have TOC measured in ppm (parts per million), and
ultrapure water (UPW) will have TOC measured in ppb (parts per billion).

Tumor
An abnormal growth of [Link] defined as a circumscribed growth, not inflammatory in character,

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arising from preexisting tissue, but independent of the normal rate or laws of growth of such tissue,
and subserving no physiological function.

Turbidity
A suspension of fine particles that obscures light rays but requires many days for sedimentation
because of small particle size.

Ultra Low Penetration Air filters (ULPA)

Extended media dry filters in a rigid frame that have a minimum particle-collection efficiency of
99.999% for particles greater than or equal to 0.12µm in size. Most commonly used in
microelectronics, few uses in pharmaceuticals.

Ultraviolet Radiation
Light in the wavelength region 200-300 nm, used to detect RNA or DNA that has the fluorescent dye,
ethidium bromide, bound to it.

Unidirectional Airflow
Previously referred as "laminar" airflow, is the "rectified airflow through the entire cross section of a
clean zone with a steady velocity and approximately parallel streamlines. This type of airflow results
in a directed transport of particles from the clean zone". ISO 14644-4.

U.S.P. (United States Pharmacopeia)

A compendium of testing and purity criteria for pharmaceuticals, ancillaries, and raw materials. (also
see: National Formulary (NF))

Vaccine
A preparation of killed microorganisms, living attenuated organisms, or living fully virulent organisms
that is administered to produce or artificially increase immunity to a particular disease.

Validation
A documented program that provides a high degree of assurance that a specific process, method, or
system will consistently produce a result meeting pre-determined acceptance criteria.

Validation Master Plan

The documented plan for qualification of a facility or part of a facility that identifies the layout of the
operation, the associated utilities and systems, the equipment, and the processes to be validated.
The validation master plan also provides preliminary information as to the extent of the qualification

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and validation (IQ, OQ, PQ), required documentation, SOPs, acceptance criteria and responsibilities.
Validation Master Plans should also establish the cross reference of qualification projects by
product, system, discipline, etc.

Validation Protocol
A written plan describing the process to be validated, including production equipment and how
validation will be conducted. Such a plan would address objective test parameters, product and
process characteristics, predetermined specifications, and factors, which will determine acceptable
results.

Verification
The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and
documenting whether items, processes, services, or documents conform to specified requirements.
(also see: IQ (Installation Qualification))

Viscosity
The tendency of a fluid to resist flowing because of molecular attraction (cohesion).

Water Treatment
Water treatment, also referred to as water conditioning, can consist of adding or removing chemicals
to change the properties of water. In water softening, for example, sodium ions are substituted for
metallic ions that cause "hardness" thus reducing the scale-forming tendencies of water. Water
purification on the other hand, always consists of removing undesirable impurities.

WFI (Water For injection), U.S.P.

WFI is water purified by distillation or by reverse osmosis, it contains no added substance. WFI
meets the purity requirements under Purified Water. Although not intended to be sterile, it meets a
test for a limit of bacterial endotoxin. It must be produced, stored, and distributed under Sterile Water
for Injection

Yield, Expected
The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of
production based on previous laboratory, pilot scale, or manufacturing data.

Yield, Theoretical
The quantity that would be produced at any appropriate phase of manufacture, processing, or

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packing of a particular API (Active Pharmaceutical Ingredient) or intermediate, based upon the
quantity of components to be used, in the absence of any loss or error in actual production.

Zygote
Single cell formed from the conjugation of gametes (egg and sperm cells). The zygote has twice as
many chromosomes as do gametes.

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