Acceptance
criteria
Means the product specifications and acceptance / rejection criteria, such
as acceptable quality level and nacceptable quality level, with an associated
sampling plan, that are necessary for making a decision to accept or reject a
lot or batch (or any other convenient sub groups of manufactured units).
Actual yield
Means the quantity that is actually produced at any appropriate phase of
manufacture, processing, or packing of a particular drug product.
Aerosol
Pressurised spray e.g. for topical pain-reliever. Uncommon as a dosage
form.
Ampoule
All-in-one closed glass container containing liquid sealed by heat
(electrical or direct flame). Opened by reaking neck.
Antibiotics
Products such as cephalosporins, generally produced by fermentation.
Production is segregated from other pharmaceutical production.
Batch
A specific quantity of a drug or other material that is intended to have
uniform character and quality, within specified limits, and is produced
according to a single manufacturing order during the same cycle of
manufacture.
Bio-safety
Safety during the handling of biological materials such as
genetically-manipulated micro-organisms. Encompasses records and procedures.
BOM
Bill of Materials.
Bulk stock
Stock of unpacked or unlabelled drug products. Generally a buffer stock
between manufacturing and packing.
Campaign
A series of production orders or jobs run end-to-end, usually of the same
or very similar products. Designed to minimise the effect of changeovers but
reduces flexibility.
Capsule
Soluble gelatine container for direct ingestion.
Component
Any ingredient intended for use in the manufacture of a drug product,
including those.
COA
Certificate of Analysis.
COC
Certificate of Conformity
Clinical Trial
Certificate
A document giving information on the presentation of a drug, its
recommended dosage, precautions associated with its use and the list of
indications for which the drug is licenced.
Derivative
A compound with modified properties derived from a basic chemical
structure.
Diagnostic reagents
Products used for in vitro analysis of patient material e.g. blood. They
have many control and manufacturing characteristics in common with
pharmaceuticals, but are usually produced in small quantities and often rely
upon natural ingredients.
Dispensing
The process of weighing out or measuring out the quantities of component
materials for a production order or job. Carried out in protected
environments. May be treated as part of the stores/warehouse operation or,
less commonly, as part of production. Specialist systems often found here.
Document Management
Manual Document Management is rapidly being superceded by computer based
Document Management Systems, also known as DMS.
Dosage
form
The physical form of a drug product e.g. tablet, ointment. Basic division
of production operations.
Drug product
A finished dosage form, for example, tablet, capsule, solution , etc., that
contains an active drug ingredient generally, but not necessarily, in
association with in active ingredients. The term also includes a finished
dosage form that does not contain an active ingredient but is intended to be
used a placebo.
Ethical
pharmaceuticals ("Ethicals")
Prescription-only drug products. Often under patent.
Excipient
Material, such as magnesium stearate or calcium carbonate, used to bulk out
the active ingredient in tablets. May also provide other properties e.g
effervescence upon solution. Excipients are "inactive ingredients"
Formulation
The recipe or product structure for a specific dosage form of a drug
product or intermediate.
GAMP
Good Automated Manufacturing Practice. A guide which explains the
recommended documentation, terminology and work methods which should be used
by suppliers of automated equipment to the pharmaceutical industry to enable
users to more easily validate these systems. GAMP was developed by the
Pharmaceutical Industry Computer Systems validation Forum.
GCP
Good Clinical Practices.
GLP
Good Laboratory Practices.
GMP
Good Manufacturing Practice. A comprehensive of standards covering the
physical production environment and its operation and maintenance, materials
and their recording and control, recallability, quality standards and their
application, personnel qualifications, validation and other topics.
cGMP
Current Good Manufacturing Practice. The version of GMP legally mandated in
the USA by the FDA; elsewhere GMP is generally operated more by consent and
agreement.
Generic pharmaceuticals ("Generics")
Non-branded drug products e.g. benzodiazepine rather than Valium. These are
generallyimitations of formulations previously covered by patents. While the
same cGMP and other regulations apply to generics as to original formulations,
the producing companies do not have the same R&D costs and can therefore
sell the products more cheaply.
Granules &
powders
Loose products, packed in bags, sachets, tubs, etc.
Hard gelatine
capsule
Two-part capsule, often in two colours. May be printed or un-printed.
Filled with powder or granulated materials (such as controlled-release
granulations). Supplied to the pharmaceutical manufacturer as empty closed
capsules which are then taken apart, filled and reassembled.
Homeopathic medicines
Ultra-low dosage medicines, generally manufactured from natural
ingredients.
Inhaler
Non-pressurised spray or pump. May be pre-filled with drug product or
supplied separately.
Injectables
Products for injection, either before or after dilution, e.g. anaesthetics.
Usually produced under sterile conditions. see also: vial, ampoule, liquid
Ingredient (Inactive)
Any component other than an "active ingredient".
Ingredients
(Natural)
Extracts from organic materials, either derived from crops or from
fermented or genetically-manipulated organisms. Essentially variable in
attributes.
In-process material
Any material fabricated, compounded, blended or derived by chemical
reaction that is produced for, and used in the preparation of the drug
product.
Intermediate
The product of a production stage other than the last, and which is an
input material for a subsequent stage.
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Leaflet
Information material often included in drug product pack. Controlled as for
labels or other printed packaging material. see also: package insert
LIMS
Laboratory Information Management Systems. These are used manage/control
laboratory equipment and to monitor/maintain results of sample tests conducted
in the laboratory.
Liquid
Any of many liquid dosage forms for oral or topical application e.g.
syrups, suspensions, linctuses. Usually supplied in bottles.
Lot
A batch, or a specific identified portion of a batch, having uniform
character and quality within specified limits; or, in the case of a drug
product produced by continuous process, it is a specific identified amount
produced in a unit of time or quantity in a manner that assures its having
uniform character and quality within specified limits.
Lot
number, control number, or batch number
Any distinctive combination of letters, numbers, or symbols, or any
combination of them, from which the complete history of the manufacture,
processing, packing, holding, and distribution of a batch or lot of drug
product or other material can be determined.
Manufacture,
processing, packing, or holding of a drug product
Includes packaging and labelling operations, testing, and quality control
of drug products.
Manufacturing
Production of basic unpacked products.
MES
Manufacturing Execution System.
A system which can be composed of a number of separate computer systems,
which when integrated together provide the tools to manage and control the
production process from planning, scheduling, manufacturing, tracking etc.
MRP
Material Requirements Planning
MRP II
Manufacturing Resource Planning
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Ointments &
creams
Products for topical application, usually presented in collapsible tubes,
tubs or jars.
Manufacturing stage
comparable with liquids. May be produced under sterile conditions e.g. eye
ointment.
Oral
For direct ingestion (administration via the mouth).
OTC
products
"Over-the-Counter" products. Drug products which can be bought at
pharmacies without prescription. The regulatory regime and manufacturing
environment are identical with ethicals.
Packaging
material
Any of the items such as bottles, tubes, cartons, labels used to contain a
drug product. Any printed packaging materials and any which are in direct
contact with the drug product will be subject to recall and traceability
requirements (q.v.).
Packing
Production of
finished drug products from bulk product and packaging materials. also but
incorrectly Packaging.
Pill
A layman's term denoting a sugar-coated tablet or a dragée.
Pre-filled syringe
Syringe for injection of drug supplied filled with exact dose. Limited
application e.g. for adrenaline or anti-histaminics.
Presentation
A version of a drug product e.g. Bactrim 5mg blister-packed x 10, Italian
labelling.
Quality
control
Used here in the narrower sense of the functions and activities connected
with sampling, analysis and approval (or rejection) of materials.
Quality control unit
Means any person or organisational element designated by the firm to be
responsible for the duties relating to quality control.
Recallability
The ability to locate, anywhere in the supply chain, drug products or their
components at any level including starting materials, and to withdraw those
products or components from the market or from use. This requires traceability
(q.v.).
Recycling
Many materials used in pharmaceutical manufacturing can be recycled. In
view of their cost and environmental impact this can be important.
Representative sample
A sample that consists of a number of units that are drawn based on
rational criteria such as random sampling and intended to assure that the
sample accurately portrays the material being sampled.
Soft gelatine
capsule
Integral capsule used for liquids. Filling is a specialist operation and
generally sub-contracted.
SCADA
Supervisory control and data acquisition.
Solvent
Liquid used to dissolve another ingredient e.g. for coating. Often
reclaimed and reprocessed.
SPC
Statistical process control providing trend analysis from real time
monitoring of process instrumentation to predict failures / variations from
standard.
Sterile production
Production activities carried out in controlled sterile environments having
filtered laminar-flow air supplies.
Strength
Means 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 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).
Substance
Alternative name for material. Generally used of active ingredients.
Tablet
Compressed, generally flattened and often circular oral dosage form
produced in tablet press from granulated dry or moist mass e.g. conventional
aspirin tablet. May be un-coated, film-coated or sugar-coated and, if coated,
printed or un-printed.
Theoretical yield
Means the quantity that would be produced at any appropriate phase of
manufacture, processing, or packing or a particular drug product, based upon
the quantity of components to be used, in the absence of any loss or error in
actual production.
Traceability
Facilities to determine the origin and destination of all quantitiesof
every lot of lot-traced materials and products. Lot tracing proceeds generally
"backwards" or "downwards" from a finished product (drug product) to one or
more lower levels (earlier in the supply chain) in order to locate dubious
lots, and then "forwards" or "upwards" to one or more higher levels to locate
all lots containing any part of the dubious lots.see also: Lot Tracing, Lot
Tracking.
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Vaccines
Injectable or oral preparations conferring immunity from specific diseases.
Vaccines are biological products.
Vial
Glass bottle-like container with stopper, usually of rubber, containing
liquid or powder.
Vitamins
Commonly found as ingredients. Most are nature-identical, some are natural
ingredients. Synthetic production is a characteristic fine chemical operation.
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