Glossary

 

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A




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.

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B




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.

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C




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.

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D




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.

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E




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"

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F




Formulation

The recipe or product structure for a specific dosage form of a drug product or intermediate.

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G




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.

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H




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.

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I




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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J




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K




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L




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.

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M




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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N




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O




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.

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P




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.

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Q




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.

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R




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.

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S




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.

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T




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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U




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V




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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W




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X




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Y




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Z




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