Glossary

Sample in which the different fractions of the material have an equal probability of being represented.

All records or certified copies of original observations, clinical findings or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Such material includes laboratory notes, memoranda, calculations and documents, as well as all records of data from automated instruments or exact, verified copies, e.g. in the form of photocopies or microfiches. Raw data can also include photographic negatives, microfilm or magnetic media (e.g. computer diskettes) and optical media (CD-ROMs).

A general term used to denote starting materials, reagents and solvents intended for use in the production of starting materials, intermediates, active pharmaceutical ingredients or final products.

The rate at which the active surface responds to time-temperature exposure.

Experiments on the physical, chemical, biological, biopharmaceutical and microbiological characteristics of a drug, during and beyond the expected shelf life and storage periods of samples under the storage conditions expected in the intended market. The results are used to establish the shelf life, to confirm the projected shelf life, and to recommend storage conditions.

A rebranded product is identical in every respect to the product manufactured by the original manufacturer, except that the product is labelled with the 'rebranded' product name and product code, and bears the rebrander's name.

A process for withdrawing or removing a pharmaceutical material from the distribution chain because of defects in the materials or complaints of a serious nature. The recall might be initiated by the manufacturer/importer/distributor or a responsible agency.

The person or organization responsible for receiving something that has sent to them by a sender.

The period between the activation of the device using the ‘start’ button or switch and the de-activation of the device either automatically or by using the ‘stop’ button or switch.

A biotherapeutic product that:

has been licensed and approved by a stringent regulatory authority on the basis of a full dossier with comprehensive data on non-clinical and clinical studies

is used as the comparator for head-to-head comparability studies with the similar biotherapeutic product in order to show similarity in terms of quality, safety and efficacy.

This definition does not refer to measurement standards such as international, pharmacopoeial, or national standards or reference standards.

A reference product is a pharmaceutical product with which the new product is intended to be interchangeable in clinical practice. The reference product will normally be the innovator product for which efficacy, safety and quality have been established. Where the innovator product is not available, the product which is the market leader may be used as a reference product, provided that it has been authorized for marketing and its efficacy, safety and quality have been established and documented.

A sample of a batch of starting material, packaging material, intermediate or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned.

A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be:

obtained from an officially recognized source

prepared by independent synthesis

obtained from existing production material of high purity

prepared by further purification of existing production material.

A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.

Microorganisms defined at least to the genus and species level, catalogued and described according to its characteristics and preferably stating its origin. Normally obtained from a recognized national or international collection.

A colour patch against which the colour of the active surface can be directly compared.

A contiguous geographical area within with the legal manufacturer or reseller is able to provide the full range of services described in specification WHO/PQS/E001/CR_FR01.

A contiguous geographical area within which the legal manufacturer or supplier has previously supplied vehicles in low- and middle-income countries.

Any statutory system of approval required at national level as a precondition for introducing a pharmaceutical product on to the market.

The process whereby regulatory requirements, approaches and systems become more similar or aligned over time as a result of the adoption of internationally recognized technical guidance, standards and best practices.

Relates to the information associated with a submission for approval by a regulatory authority. The submitted version is defined by all of the documentation related to development, manufacture and intended use, labelling and post-market surveillance of the product and all the documented evidence supporting the safety and performance claims associated with that submission. If any aspect of this documentation differs in any way between the submissions to different regulatory authorities or assessment bodies (United States Food and Drug Administration, Health Canada, a Notified Body for CE marking, etc.) it is considered to be a different regulatory version.

The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of an API or FPP at the time of its release.

A system including programmable temperature and event monitor and peripheral devices in compliance with WHO PQS E006/TR03.

A commercial entity, licensed to act on behalf of a legal manufacturer and which carries product liability and warranty responsibilities no less onerous than those carried by the legal manufacturer.

A sample of a fully packaged unit from a batch of finished product. It is stored for identification purposes (for example, of presentation, packaging, labelling, patient information leaflet, batch number and expiry date) should the need arise during the shelf life of the batch concerned.

Combination of the probability of occurrence of harm and severity of the harm.

The estimation of the risk associated with the identified hazards.

A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the evaluation of risk associated with exposure to those hazards.

The sharing of information about risk and risk management between the decisionmaker and other stakeholders.

The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.

The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.

A detailed description of the activities that continuously ensure patients' safety and their benefit from a medicinal ingredient. A risk management plan includes:

safety specifications, which summarize the known and potential safety issues and missing information about the rDNA-derived biotherapeutic

a pharmacovigilance plan to further evaluate important known or potential safety concerns and to provide post-marketing data where relevant information is missing

a risk minimization plan, which provides proposals on how to minimize any identified or potential safety risk.

Review or monitoring of output or results of the risk management process considering (if appropriate) new knowledge and experience about the risk.

The ability of the procedure to provide analytical results of acceptable accuracy and precision under a variety of conditions.

The load applied to a cold room or freezer room floor arising from the routine use of metal-wheeled manual pallet trucks and/or powered or manually operated rubber-wheeled pallet lifting equipment.