Current Good Manufacturing Practice For Drugs A.o 43 S, 1999

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The nearest value obtained during measurement or analysis to the true value.

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Accuracy

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The quantity that is actually produced at any phase of production of a particular
drug product based on the initial input.

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Actual Yield

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An enclosed space with two or more doors, which is interposed between two or
more rooms e.g. of different standard of cleanliness for the purpose of
controlling the air flow between those rooms when they need to be entered. An
airlock may be designed for and used by either people or materials; in the latter
case it can be termed a “pass through hatch”. An airlock can also be the
“anteroom” to a clean room in which sterile goods are handled.

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Airlock

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A supplier of all components of finished products generally approved for use by
the trade and accredited by the manufacturer based on a vendor rating which
include but not limited to conformance to the company or compendium material
specifications.

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Approved Supplier

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A quantity of drug product/device that is homogenous in character and quality
produced during a given cycle of manufacture and from a specific
manufacturing order.

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Batch

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A designation in numbers or letters or combination thereof that identifies the
batch, and permits the tracing of the complete history of a batch, including all
stages of its production, control and distribution.

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Batch Number or Lot Number

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A contained system, such as a fermenter, into which biological agents are introduced together with other materials in order to effect their multiplication or their production of other substances by reaction with other materials. They are generally equipped with devices for regulation, control connection, material addition and material withdrawal.

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Biogenerator

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Including genetically engineered microorganisms, cell cultures, as well as endoparasites, whether pathogenic or not.

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Microbiological Agents

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This is collected from a single donor and processed either for transfusion
or further manufacturing.

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Blood

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Any processed material which has to undergo another process including
packaging operation to become a finished product.

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Bulk Product

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The operations carried out to determine the accuracy of measuring instruments,
of “material measures” such as masses or gauges and of measurement
standards.

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Calibration

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A system whereby successive batches of a product manufactured by culture in
cells derived from the same master cell bank (see Master Cell Bank). The cell
bank system is validated for a passage level or number of population doubling
beyond that which was achieved during routine production.

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Cell Bank System

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The in-vitro growing of cells isolated from multicellular organisms.

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Cell Culture

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An area with defined environmental control of particulate and microbial
contamination, constructed and used in such a way as to minimize the
introduction, generation and retention of contaminants within the area.

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Clean Area

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The in-vitro serological tests performed on donor and recipient blood samples to
establish the serological matching of a donor’s blood or blood components with
that of a potential recipient.

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Compatibility Testing

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Any material intended to be used for the manufacture of a product whether raw
or packaging materials.

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Component

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An area constructed, operated and equipped with air-handling and filtration
system in order to prevent contamination of the external environment by
biological agents from within the area.

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Contained Area

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Anything that cause contamination to the product.

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Contaminants

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An area constructed and operated to control the introduction of potential
contamination (an air supply approximately class III may be appropriate), and
the consequences of accidental release of living organisms. The level of control
exercise shall reflect the nature of the organism employed in the process. The
area shall be maintained at a pressure negative to the immediate external
environment and allow for the efficient removal of small quantities of airborne
contaminants.

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Controlled Area

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Contaminations of a starting, intermediate product or finished product.

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Cross Contamination

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A container designed to store liquefied gas at extremely low temperature.

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Cryogenic Vessel

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A container designed to store gas at a high pressure.

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Cylinder

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The date indicating the start of processing of every batch.

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Date of Manufacture

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The activity of weighing, counting or measuring and checking of starting
materials and issuing these to the appropriate production personnel; details of
the activity being duly and properly documented.

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Dispensing

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Written recording of all procedures, instructions and processes involved in the
manufacture of drug products.

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Documentation

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Any substance or mixture of substances in finished dosage forms that is
manufactured, offered for sale, or presented for use in (1) the treatment,
mitigation, cure, prevention, or diagnosis of disease, abnormal physical state, or
the symptoms thereof in man or animal; or (2) the restoration, correction or
modification of organic functions in man or animal; regardless of whether it is in
package form.

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Drug Product

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Instrument, apparatus, or contrivances, including their components, parts and
accessories, intended (1) for use in the diagnosis, cure, mitigation, or
prevention of disease in man and animals; or (2) to affect the structure or any
function of the body of man or animal.

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Device

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A date fixed for each individual batch on or before which the batch is expected
to meet the standard specifications for quality, safety and efficacy.

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Expiration Date

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Any area used for the collection, processing, compatibility testing, storage or distribution of blood and blood components.

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Facilities - For Blood Products

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This refers to the building, premises and equipment necessary in the
manufacture of drugs.

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Facilities - For Other Products (drugs, medical devices, bulk chemical material and
others)

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A product which has undergone all stages of manufacturing operations.

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Finished Product

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It is the system of quality assurance aimed at ensuring that products are
consistently manufactured to a quality appropriate for their intended use. It is
thus concerned with both manufacturing and quality control processes and
procedures.

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Good Manufacturing Practice (GMP)

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Contaminated with extraneous biological agents and therefore capable of
spreading infection.

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Infected ( Man or Animal )

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Checks and tests instituted and carried out in the course of the manufacture of
a drug to assure identity, strength, quality and purity.

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In-Process Control

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Any processed substance or mixture of substances which has to undergo one
or more further stages of processing to become finished product.

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Intermediate Product

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The process in which blood is extracted from the donor, a leukocyte concentrate
is separated, and the remaining formed elements and residual plasma are
returned to the donor.

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Leukopheresis

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Gases that, at the specified temperature and pressure, remain as a liquid in the
cylinder.

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Liquefied Gases

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A batch or any portion of batch produced by a continuous process, an amount of
drugs produced in a unit of time or quantity in a manner that assures its
uniformity and in either case which is identified by a distinctive lot number and
has uniform character and quality within specified limits.

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Lot

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Equipment or apparatus designed to enable one or more gas containers to be
filled simultaneously from the same source.

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Manifold

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The complete set of activities to produce a drug that comprise production and
quality control from dispensing of materials to the release for distribution of the
finished product.

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Manufacture or Manufacturing

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A culture of fully characterized cells filled into containers in a single operation,
processed together and stored to ensure uniformity and stability. A master cell
bank is normally stored at -70oC or lower.

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Master Cell Bank

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A culture of a microorganism distributed from a single bulk into containers in a
single operation to ensure uniformity, stability and to prevent contamination.

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Master Seed Lot

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The process of packing which is that part of the production cycle applied to a
bulk product to obtain the finished product.

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Packaging

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Any material used in the packaging of a bulk product to obtain the finished
product.

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Packaging Material

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The liquid portion of blood separated and used as material to prepare another
product.

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Plasma or Serum (for further manufacture)

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The process in which blood is extracted from the donor, the plasma is
separated from the formed elements and at least the red blood cells are
returned to the donor.

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Plasmapheresis

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The process in which blood is extracted from the donor, the platelet concentrate
is separated, and the remaining formed elements and residual plasma are
returned to the donor.

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Plateletpheresis

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The degree of variation between individual test results when the method is used
separately to different samples drawn from the same batch of material. This will
include variation between analysts, between days, between tests on the same
prepared extract of a given sample, between different extracts and between
laboratories conducting the same test. It is normally divided into two types:
- Repeatability (within laboratory), and
- Reproducibility (between laboratories).

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Precision ( in analytical assay and method)

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A system of containment that prevents the dispersal of a biological agent into
the immediate working environment. It involves the employment of closed
containers or safety biological cabinets accompanied with secure operating
procedures.

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Primary Containment

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Description of the operations to be executed, the precautions to be implemented
directly or indirectly related to the manufacture of a drug.

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Procedures

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The part of production cycle starting from weighing of raw materials to finished
product.

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Processing

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Any process employed after collection and before computability testing of blood.
It includes the identification of a unit of donor blood, the preparation of
components from such unit of donor blood, serological testing, labeling and
associated record keeping.

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Processing of Blood

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All operations starting from dispensing of materials to processing, packaging, to
finished product.

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Production

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All control measures taken designed to ensure that finished products
consistently conform to established specification of identity, strength, purity and
quality.

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Quality Control

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An act of holding off a material for use, or a product for packaging or distribution
by physically setting it apart or by system duly validated, pending a decision on
release or rejection.

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Quarantine

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All substances whether active or excipients that are employed in the processing
of a finished product.

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Raw Material

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A resolution between the theoretical and actual yield.

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Reconciliation

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The incorporation of all or part of previous batches with the required quality into
another batch at a defined step of production.

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Recovery

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The status of materials or products which are not permitted to be used for
processing, packaging or distribution.

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Rejected

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The status of materials or products which are permitted to be used for
processing, packaging or distribution.

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Released or Passed

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A sample representing the lot, the batch, or the total amount of materials based
on a sampling plan.

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Representative Sample

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The reworking of all or part of a batch of product of an unacceptable quality
from a defined step of production in order that its quality may be rendered
acceptable by one or more additional operations.

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Reprocessing

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Any finished product which is already in distribution and sent back to the
manufacturer or distributor due to complaint, damage, expiration, validity or other reasons such as the condition of the container or package which may cast doubt on the product identity, quality, strength and safety.

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Returned Product

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All measures taken to assure suitable or adequate environmental conditions in
compliance to GMP.

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Sanitation

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Secondary containment is a system of containment that prevents the dispersal
of a biological agent into the external environment or into other working areas. It
involves the use of rooms with specially designed air handling, the existence of
air locks and/or sterilizers for the exit of material. It may add to the effectiveness
of primary containment

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Secondary Containment

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A seed lot system is a system where successive batches of product are derived
from the same master seed lot at a given passage level.

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Seed Lot System

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A description of starting material, intermediate, bulk or finished product in terms
of its chemical, physical and microbiological characteristics, if any. A
specification shall include descriptive and or numerical clauses stating
standards and tolerated deviations, whenever applicable.

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Specification of Material

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Raw materials used in the production of a finished product (drugs).

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Starting Materials

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A room or area of defined environmental condition with controlled particulate
and microbial contamination, constructed, equipped and used to eliminate the
introduction, generation or retention of contaminants.

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Sterile Room or Sterile Area

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Inactivation or reduction to an acceptable level of all viable microorganisms by a
suitable process.

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Sterilization

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The quantity that is expected or planned to be obtained at any phase of
production of a particular product, based on the quantity of components to be
used.

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Theoretical Yield

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The volume of blood or one of its components in a suitable volume of
anticoagulant obtained from a single collection of blood.

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Unit (of Blood)

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The process of confirming by recognized appropriate means or manner, that
any material, process, procedure, activity, system, equipment or mechanics
used in production and control consistently achieved the desired results.

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Validation

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A culture of cell derived from the master cell bank and intended for use in the
preparation of production of cell cultures and normally stored at - 70OC or
lower.

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Working Cell Bank

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A culture of microorganism derived from the master seed lot and intended for
use in production.

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Working Seed Lot

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A condition or set of conditions encompassing upper and lower processing
limits and circumstances, within standard operating procedures, which pose the
greatest chance of product or process failure when, compared to ideal
conditions. Such conditions do not necessarily induce product or process
failure.

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Worst Case