Arrangement undertaken by and legally binding on parties.
Auditing is an independent, objective assurance and consulting activity designed to add
value and improve an organization's operations. It helps an organization accomplish its
objectives by bringing a systematic, disciplined approach to evaluate and improve the
effectiveness of risk management, control, and governance processes.
(modified, from Professional Practices Framework published by the Institute of Internal
A defined quantity of starting material, packaging material or product processed in a single
process or series of processes so that it is expected to be homogeneous. (For further details
please see Good manufacturing practices for pharmaceutical products: main principles.
WHO Technical Report Series, No. 908, 2003, Annex 4.)
A distinctive combination of numbers and/or letters which uniquely identifies a batch on the
labels, its batch records and corresponding certificates of analysis, etc.
Any product that has completed all processing stages up to, but not including, final packaging.
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.
Consignment (or delivery)
The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time
in response to a particular request or order. A consignment may comprise one or more
packages or containers and may include material belonging to more than one batch.
The material employed in the packaging of a pharmaceutical product. Containers include
primary, secondary and transportation containers. Containers are referred to as primary if they
are intended to be in direct contact with the product. Secondary containers are not intended to
be in direct contact with the product.
Contamination (new: "handling" added)
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign
matter, into or on to a starting material, intermediate or pharmaceutical product during
handling, production, sampling, packaging or repackaging, storage or transport.
Business agreement for the supply of goods or performance of work at a specified price.
А counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to
identity and/or source. Counterfeiting can apply to both branded and generic products and
counterfeit products and may include products with the correct ingredients or with the wrong
ingredients, without active ingredients, with insufficient active ingredients or with fake
Contamination of a starting material, intermediate product or finished product with another
starting material or product during production.
The division and movement of pharmaceutical products from the premises of the manufacturer
of such products, or another central point, to the end user thereof, or to an intermediate point by
means of various transport methods, via various storage and/or health establishments.
A substance or compound, other than the active pharmaceutical ingredient and packaging
materials, that is intended or designated to be used in the manufacture of a pharmaceutical
The date given on the individual container (usually on the label) of a 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
FEFO (First Expiry/First Out)
A distribution procedure that ensures the stock with the earliest expiry date is distributed and/or
used before an identical stock item with a later expiry date is distributed and/or used; EEFO
(Earliest Expiry/First Out) shall have a similar meaning.
FIFO (First In/First Out)
A distribution procedure to ensure that the oldest stock is distributed and/or utilized
before a newer and identical stock item is distributed and/or utilized.
Good distribution practices (GDP) (new)
Good Distribution Practices are that part of quality assurance that ensure that the quality of a
pharmaceutical products is maintained through adequate control throughout the numerous
activities which occur during the distribution process.
Good manufacturing practices (GMP )
That part of quality assurance which ensures that products are consistently produced and
controlled to the quality standards appropriate to their intended use and as required by the
Good Storage Practices (new)
Good Storage Practices are that part of quality assurance that ensure that the quality of a
pharmaceutical products is maintained through adequate control throughout the storage.
Good Trade and Distribution practices (new)
Good Trade and Distribution Practices are that part of quality assurance that ensure that the
quality of a pharmaceutical products is maintained through adequate control throughout the
numerous activities which occur during the trade and the distribution process.
A health establishment is the whole or part of a public or private facility, building or place,
whether operated for profit or not, that is operated or designed to provide health care services
including the supply of pharmaceutical products to the end user.
The act of bringing or causing any goods to be brought into a customs territory (national
territory, excluding any free zone).
Partly processed product that must undergo further manufacturing steps before it becomes a
Process of identifying a product including the following information, as appropriate: - name, -
active ingredient(s): type and amount, - batch number , - expiry date, - special storage
conditions or handling precautions, - directions for use, warnings, and precautions, - names and
addresses of the manufacturer and/or the supplier.
(adapted from GMP, chapter 15.11)
All operations of purchase of materials and products, production, quality control, release,
storage and distribution of pharmaceutical products, and the related controls.
A general term used to denote starting materials (active pharmaceutical ingredients and
excipients), reagents, solvents, process aids, intermediates, packaging materials and
Any medicine intended for human use or veterinary product administered to foodproducing
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.
Product recall is a process for withdrawing or removing a pharmaceutical product from the
pharmaceutical distribution chain because of defects in the product or complaints of serious
adverse reactions to the product. The recall might be initiated by the manufacturer/importer/
distributor or a responsible agency.
Quality assurance is a wide-ranging concept covering all matters that individually or
collectively influence the quality of a product. It is the totality of the arrangements made with
the object of ensuring that pharmaceutical products are of the quality required for their intended
Quality control covers all measures taken, including the setting of specifications, sampling,
testing and analytical clearance, to ensure that starting materials, intermediates, packaging
materials and finished pharmaceutical products conform with established specifications for
identity, strength, purity and other characteristics.
An appropriate infrastructure, encompassing the organizational structure, procedures,
processes and resources, and systematic actions necessary to ensure adequate confidence
that a product (or services) will satisfy given requirements for quality.
The status of starting or packaging materials, intermediates, or bulk or finished products
isolated physically or by other effective means while a decision is awaited on their release,
rejection or reprocessing.
Operations designed to obtain a representative portion of a pharmaceutical product, based on an
appropriate statistical procedure, for a defined purpose, e.g. acceptance of consignments, batch
The period of time during which a finished pharmaceutical product, if stored correctly, is
expected to comply with the specification as determined by stability studies on a number of
batches of the product. The shelf-life is used to establish the expiry date of each batch.
Standard operating procedure (SOP)
An authorized, written procedure giving instructions for performing operations not necessarily
specific to a given product but of a more general nature (e.g. equipment 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
The storing of pharmaceutical products up to the point of use.
Going, conveying, being conveyed, across, or over or through; passage, route,