Annual Review An evaluation, conducted at least annually, that assesses the quality standards

of each drug product to determine the need for changes in drug product specifications or
manufacturing or control procedures
CAPA Corrective and preventive action: A systematic approach that includes actions needed to
correct (correction), prevent recurrence (corrective action), and eliminate the cause of
potential nonconforming product and other quality problems (preventive action) (21CFR
820.100)
Continual Improvement Ongoing activities to evaluate and positively change products,
processes, and the quality system to increase effectiveness
Correction Repair, rework, or adjustment relating to the disposition of an existing discrepancy
Corrective Action Action taken to eliminate the causes of an existing discrepancy or other
undesirable situation to prevent recurrence
Customer A person or organization (internal or external) that receives a product or service
anywhere along the products life cycle
Discrepancy Datum or result outside of the expected range; an unfulfilled requirement; may be
called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend
Harm Damage to health, including the damage that can occur from the loss of product quality
or availability
Non-conformity A deficiency in a characteristic, product specification, process parameter,
record, or procedure that renders the quality of a product unacceptable, indeterminate, or not
according to specified requirements
Preventive Action Action taken to eliminate the cause of a potential discrepancy or other
undesirable situation to prevent such an occurrence
Product/Service The intended results of activities or processes; products/services can be
tangible or intangible
Quality A measure of a product or services ability to satisfy the customers stated or implied
needs
Quality Assurance Proactive and retrospective activities that provide confidence that
requirements are fulfilled
Quality Control The steps taken during the generation of a product or service to ensure that it
meets requirements and that the product or service is reproducible
Quality Management Accountability for the successful implementation of the quality system
Quality Objectives Specific measurable activities or processes to meet the intentions and
directions as defined in the quality policy
Quality Plan The documented result of quality planning that is disseminated to all relevant
levels of the organization
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Quality Planning A management activity that sets quality objectives and defines the
operational and/or quality system processes and the resources needed to fulfill the objectives
Quality Policy A statement of intentions and direction issued by the highest level of the
organization related to satisfying customer needs. It is similar to a strategic direction that
communicates quality expectations that the organization is striving to achieve.
Quality System Formalized business practices that define management responsibilities for
organizational structure, processes, procedures, and resources needed to fulfill product/service
requirements, customer satisfaction, and continual improvement
Quality Unit A group organized within an organization to promote quality in general practice
Risk The combination of the probability of occurrence of harm and the severity of that harm
Risk Assessment A systematic process for organizing information to support a risk decision
that is made within a risk management process. The process consists of the identification of
hazards and the analysis and evaluation of risks associated with exposure to those hazards.
Risk Management The systematic application of quality management policies, procedures, and
practices to the tasks of assessing, controlling, communicating, and reviewing risk
Senior Management Top management officials in a firm who have the authority and
responsibility to mobilize resources
Stakeholder An individual or organization having an ownership or interest in the delivery,
results, and metrics of the quality system framework or business process improvements
Verification Confirmation, through the provision of objective evidence, that specified
requirements have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ
Quality Audit Division, J.P. Russell, and Editor)

Validation Validation is a documented evidence which provides a high degree of assurance

that a specific process, method or system will consistently produce to the required specification in
accordance with accepted standards of cGMP.
Active pharmaceutical ingredient (API) - Any substance or mixture of substances intended to
be used in the manufacture of a pharmaceutical dosage form and that, when used in the
production of a drug, becomes an active ingredient of that drug. Such substances are intended to
furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment
or prevention of disease, or to affect the structure and function of the body.
Contamination - The undesired introduction of impurities of a chemical or microbiological
nature, or of foreign matter, into or onto a starting material, or intermediate or finished product
during production, sampling, packaging or repackaging, storage or transport.
Cross-contamination - Contamination of a starting material, intermediate product or finished
product with another starting material or product during production.
Excipient- A substance, other than the active ingredient, which has been appropriately evaluated
for safety and is included in a drug delivery system to:
aid in the processing of the drug delivery system during its manufacture;
protect, support or enhance stability, bioavailability, or patient acceptability;
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 assist in product identification; or

enhance any other attribute of the overall safety and effectiveness of the drug during storage or
use.
Expiry date - The date given on the individual container (usually on the label) of a drug product
up to and including which the product is expected to remain within specifications, if stored
correctly. It is established for each batch by adding the shelf-life to the date of manufacture.
Labelling - The action involving the selection of the correct label, with the required information,
followed by line clearance and application of the label.
Manufacture - All operations of purchase of materials and products, production, quality control,
release, storage and distribution of finished products, and the related controls.
Material - A general term used to denote starting materials (active pharmaceutical ingredients
and excipients), reagents, solvents, process aids, intermediates, packaging materials and labelling
materials.
Packaging material - Any material, including printed material, employed in the packaging of a
pharmaceutical product, but excluding any outer packaging used for transportation or shipment.
Packaging materials are referred to as primary or secondary according to whether or not they are
intended to be in direct contact with the product.
Pharmaceutical product - Any medicine intended for human use or veterinary product
administered to food-producing animals, presented in its finished dosage form or as a starting
material for use in such a dosage form, that is subject to control by pharmaceutical legislation in
both the exporting state and the importing state.
Production - All operations involved in the preparation of a pharmaceutical product, from receipt
of materials, through processing, packaging and repackaging, labelling and relabelling, to
completion of the finished product.
Retest date - The date when a material should be re-examined to ensure that it is still suitable for
use.
Storage - The storing of pharmaceutical products and materials up to their point of use.
Supplier - A person providing pharmaceutical products and materials on request. Suppliers may
be agents, brokers, distributors, manufacturers or traders. Where possible, suppliers should be
authorized by a competent authority.
Calibration (old)
The performance of tests and retests to ensure that measuring equipment (e.g. for temperature,
weight, pH) used in a manufacturing process or analytical procedure (in production or quality
control) gives measurements that are correct within established limits.
Calibration (new)
The set of operations that establish, under specified conditions, the relationship between values
indicated by an instrument or system for measuring (especially weighing), recording, and
controlling, or the values represented by a material measure, and the corresponding known values
of a reference standard. Limits for acceptance of the results of measuring should be established.
Computer validation
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Documented evidence, which provides a high degree of assurance that a computerized system
records data correctly and that data processing complies with, predetermined specifications.
Concurrent validation
Validation carried out during routine production of products intended for sale.
Cleaning validation
Documented evidence to ensure that cleaning procedures are removing residues to predetermined
levels of acceptability, taking into consideration i.e. batch size, dosing, toxicology, equipment
size, etc.
Design Qualification (DQ)
Documented evidence that the premises, supporting utilities, equipment and processes have been
designed in accordance with the requirements of GMP.
Good Engineering Practices
Established engineering methods and standards that are applied throughout the project lifecycle to
deliver appropriate, cost-effective solutions.
Installation Qualification (IQ)(old)
IQ is the documentary evidence to verify that the equipment has been built and installed in
compliance with design specifications.
Installation Qualification (IQ)(new)
The performance of tests to ensure that the installations (such as machines, measuring devices,
utilities, manufacturing areas) used in a manufacturing process are appropriately selected and
correctly installed and operate in accordance with established specifications.
Working document QAS/03.055/Rev.2
Operational Qualification (OQ)(old)
OQ is the documentary evidence to verify that the equipment operates in accordance with its
design specifications in its normal operating range and performs as intended throughout all
anticipated operating ranges.
Operational Qualification (OQ)(new)
Documented verification that the system or subsystem performs as intended over all anticipated
operating ranges.
Performance Qualification (PQ)
PQ is the documentary evidence, which verifies that the equipment or system operates
consistently and gives reproducibility within defined specifications and parameters for prolonged
periods. (The term process validation may also be used.)
Process validation (See Validation)
Documented evidence, which provides a high degree of assurance that a specific process will
consistently produce a product meeting its pre-determined specifications and quality
characteristics.
Prospective validation
Validation carried out during the development stage by means of a risk analysis of the production
process, which is broken down into individual steps; these are then evaluated on the basis of past
experience to determine whether they may lead to critical situations.
Qualification (new)
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Action of proving and documenting that any premises, systems and equipment are properly
installed, and/or work correctly and lead to the expected results. Qualification is often a part
(Initial stage) of Validation, but the individual qualification steps alone do not constitute process
validation.
Retrospective validation
Involves the examination of past experience of production on the assumption that composition,
procedures, and equipment remain unchanged.
Revalidation (old)
Involves the repeat of the initial process validation to provide assurance that changes in the
process and/or in the process environment, whether intentional or unintentional, do not adversely
affect process characteristics and product quality.
Revalidation (new)
Repeated validation of an approved process (or a part thereof) to ensure continued compliance
with established requirements.
Standard operating procedure (SOP)
An authorized written procedure giving instructions for performing operations not necessarily
specific to a given product or material but of a more general nature [new] (e.g. equipment
Working document QAS/03.055/Rev.2 operation, maintenance and cleaning; validation; cleaning
of premises and environmental control; sampling and inspection). Certain SOPs may be used to
supplement product-specific master and batch production documentation.
Validation (new)
Validation is a documented evidence which provides a high degree of assurance that a specific
process, method or system will consistently produce to the required specification in accordance
with accepted standards of cGMP.
Validation Protocol (VP)(old)
The VP is a written plan stating how validation will be conducted, including test parameters,
product characteristics, production equipment and decision points on what constitutes acceptable
test results.
Validation Protocol (or plan) (VP)(new)
A document describing the activities to be performed in a validation, including the acceptance
criteria for the approval of a manufacturing process - or a part thereof - for routine use.
Validation Report (VR)(old)
The VR is a written report on the validation activities, the validation data and the conclusions
drawn.
Validation Report (VR)(new)
A document in which the records, results and evaluation of a completed validation programmed is
assembled. It may also contain proposals for the improvement of processes and/or equipment.
Validation Master Plan (VMP)
VMP is a high level document that establishes an umbrella validation plan for the entire project
and summarizes the manufacturers overall philosophy and approach, to be used for establishing
performance adequacy. It provides information on the manufacturers validation work
programmed and defines details of and time-scales for the validation work to be performed,
including stating the responsibilities relating to the plan.
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Verification
The application of methods, procedures, tests and other evaluations, in addition to monitoring, to
determine compliance with the GMP principles.
Worst case
A condition or set of conditions encompassing upper and lower processing limits and
circumstances, within SOPs, which pose the greatest chance of product or process failure when
compared to ideal conditions. Such conditions do not necessarily include product or process
failure.
Air lockA small room with interlocked doors, constructed to maintain air pressure control between
adjoining rooms (generally with different air cleanliness standards). The intent of an aseptic
processing airlock is to preclude ingress of particulate matter and microorganism contamination
from a lesser-controlled area.
Alert LevelAn established microbial or airborne particle level giving early warning of potential drift from
normal operating conditions and triggers appropriate scrutiny and follow-up to address the
potential problem. Alert levels are always lower than action levels.
Action LevelAn established microbial or airborne particle level that, when exceeded, should trigger
appropriate investigation and corrective action based on the investigation.
Aseptic Manufacturing AreaThe classified part of a facility that includes the aseptic processing room and ancillary clean
rooms. For purposes of this document, this term is synonymous with aseptic processing facility
as used in the segregated segment context.
Aseptic Processing FacilityA building, or segregated segment of it, containing clean rooms in which air supply, materials,
and equipment are regulated to control microbial and particle contamination.
Aseptic Processing RoomA room in which one or more aseptic activities or processes is performed.
AsepsisA state of control attained by using an aseptic work area and performing activities in a manner
that precludes microbiological contamination of the exposed sterile product.
BioburdenThe total number of microorganisms associated with a specific item prior to sterilization.
BarrierA physical partition that affords aseptic processing area (ISO 5) protection by partially separating
it from the surrounding area.
Biological Indicator (BI)A population of microorganisms inoculated onto a suitable medium (e.g., solution, container or
closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle
efficacy of a physical or chemical process. The challenge microorganism is selected based upon
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its resistance to the given process. Incoming lot D-value and microbiological count define the
quality of the BI.
Clean AreaAn area with defined particle and microbiological cleanliness standards.
Clean room-

A room designed, maintained, and controlled to prevent particle and microbiological

contamination of drug products. Such a room is assigned and reproducibly meets an
appropriate air cleanliness classification.
ComponentAny ingredient intended for use in the manufacture of a drug product, including those that may
not appear in the final drug product.
Colony Forming Unit (CFU)A microbiological term that describes the formation of a single macroscopic colony after the
introduction of one or more microorganisms to microbiological growth media. One colonyforming unit is expressed as 1 CFU.
Critical Area
An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures,
and equipment may be exposed in critical areas.
Clean ZoneSee Clean Area.
Critical surfacesSurfaces that may come into contact with or directly affect a sterilized product or its containers or
closures. Critical surfaces are rendered sterile prior to the start of the manufacturing operation,
and sterility is maintained throughout processing.
DecontaminationA process that eliminates viable Bioburden via use of sporicidal chemical agents.
DisinfectionProcess by which surface Bioburden is reduced to a safe level or eliminated. Some Disinfection
agents are effective only against vegetative microbes, while others possess additional capability
to effectively kill bacterial and fungal spores.
DepyrogenationA process used to destroy or remove pyrogens (e.g., endotoxin).
D valueThe time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent
reduction in the population of a specific microorganism.
DynamicConditions relating to clean area classification under conditions of normal production.
Endotoxin- A
Pyrogenic product (e.g., lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead
to reactions in patients receiving injections ranging from fever to death.
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Gowning Qualification- A program that establishes, both initially and on a periodic basis, the
capability of an individual to don the complete sterile gown in an aseptic manner.
HEPA filterHigh efficiency particulate air filters with minimum 0.3 m particle retaining efficiency of 99.97
percent.
HVACHeating, ventilation, and air conditioning.
InterventionAn aseptic manipulation or activity that occurs at the critical area.
Isolator- A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that
provides uncompromised, continuous isolation of its interior from the external environment (e.g.,
surrounding cleanroom air and personnel). There are two major types of isolators:
Closed isolator systems exclude external contamination from the isolators interior by
accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of
openings to the surrounding environment. Closed systems remain sealed throughout operations.
Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or
egress of materials during operations through one or more openings. Openings are engineered
(e.g., using continuous overpressure) to exclude the entry of external contamination into the
isolator.
Laminar flowAn airflow moving in a single direction and in parallel layers at constant velocity from the
beginning to the end of a straight-line vector.
Operator- Any individual participating in the aseptic processing operation, including line set-up,
filler, maintenance, or other personnel associated with aseptic line activities.
Overkill sterilization process- A process that is sufficient to provide at least a 12 log reduction of
microorganisms having a minimum D value of 1 minute.
PyrogensA substance that induces a febrile reaction in a patient.
Sterile Product- For purposes of this guidance, sterile product refers to one or more of the
elements exposed to aseptic conditions and ultimately making up the sterile finished drug
product. These elements include the containers, closures, and components of the finished drug
product.
Sterilizing grade filterA filter that, when appropriately validated, will remove all microorganisms from a fluid stream,
producing a sterile effluent.
Quality Control UnitAn organizational element with authority and responsibility as defined by 211.22.
Unidirectional flowAn airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed
to reproducibly sweep particles away from the critical processing or testing area.
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The application of a lethal agent to sealed, finished drug products for the purpose of achieving a
predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a no
sterile unit of greater than one in a million).
ULPA filterUltra-low penetration air filter with minimum 0.3 m particle retaining efficiency of 99.999
percent.
ValidationEstablishing documented evidence that provides a high degree of assurance that a specific process
will consistently produce a product meeting its predetermined specifications and quality
attributes.
or
Validation is a documented evidence which provides a high degree of assurance that a specific
process, method or system will consistently produce to the required specification in accordance
with accepted standards of cGMP.

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