Glossary

A portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. If the quantity of material available is not sufficient for the intended analyses and for the retention samples, the inspector should record that the sampled material is the available sample (see Sampling record) and the evaluation of the results should take account of the limitations that arise from the insufficient sample size.

A product in a given presentation (identified by its name, content of active pharmaceutical ingredient(s) (API(s)), dosage form, strength, batch number, production date (if known), expiration date, collection date and name of manufacturer or labelled registration holder) collected at the specific sample collection site. It means that the same product characterized by the same name, content of APIs, dosage form, strength, batch, and from the same manufacturer collected in two different sites represents two samples. Each sample should consist of the number of dosage units (e.g. tablets, capsules, ampoules, vials or bottles) required by the sampling plan.

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 or batch release.

That part of the sampling procedure dealing with the method prescribed for withdrawing samples.

A plan that contains detailed identification of sites where samples will be collected, medicines to be sampled, minimum number of dosage units to be collected per sample, number of samples to be collected per medicine and total number of samples to be collected in the area for which the sampling plan is prepared. It also contains detailed instructions for sample collectors.

The complete sampling operations to be performed on a defined material for a specific purpose. A detailed written description of the sampling procedure is provided in the sampling protocol.

Written record of the sampling operations carried out on a particular material for a defined purpose. The sampling record should contain the batch number, date and place of sampling, reference to the sampling protocol used, a description of the containers and of the materials sampled, notes on possible abnormalities, together with any other relevant observations, and the name and signature of the inspector.

Discrete part of a consignment such as an individual package, drum or container.

A secondary chemical reference substance is a substance whose characteristics are assigned and/or calibrated by comparison with a primary chemical reference substance. The extent of characterization and testing of a secondary chemical reference substance may be less than for a primary chemical reference substance.

A carton which contains a number of individual primary containers. Most countries have traditionally stored and distributed vaccines in these cartons.

A substance whose characteristics are assigned and/or calibrated by comparison with a primary reference substance. The extent of characterization and testing of a secondary reference substance may be less than for a primary reference substance.Note: Often referred to as an “in-house” working standard.

A preparation of live cells (prokaryotic or eukaryotic) or viruses constituting the starting material for the vaccine antigen. A seed lot is of uniform composition (although not necessarily clonal), is derived from a single culture process and is aliquoted into appropriate storage containers, from which all future vaccine production will be derived either directly or via a seed lot system. A master seed lot (MSL) is a lot or bank of cells or viruses from which all future vaccine production will be derived. The MSL represents a well-characterized collection of cells or viruses of uniform composition. May also referred to as “master virus seed” for virus seeds, “master seed bank” or “master seed antigen”. A working seed lot (WSL) is a cell or viral seed lot derived by propagation from the MSL under defined conditions and used to initiate production of vaccines on a lot-by-lot basis. May also be referred to as “working virus seed” for virus seeds, “working seed bank” or “working seed antigen”.

The person or organization responsible for sending something to a receiver. 

An event that is associated with death, admission to hospital, prolongation of a hospital stay, persistent or significant disability or incapacity, or is otherwise life threatening in connection with a clinical trial.

The period of time during which a pharmaceutical product, if stored as indicated on the label, 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.

Insulated packaging used for shipping vaccines, as described in the WHO document: Guidelines on the international packaging and shipping of vaccines (WHO/IVB/05.23).

An accidental electrical circuit in a device with no or low resistance when compared to that of the normal circuit, especially one resulting from the unintended contact of components and consequent accidental diversion of current.

A biotherapeutic product that is similar in terms of quality, safety and efficacy to a reference biotherapeutic product.

Absence of a relevant difference in the parameter of interest. A difference that is expected to induce a difference in clinical effect, such as better impurity profile, could be accepted. No differences exist that are expected to induce impact on clinical activities based on a comparability or similarity exercise.

A site master file is a document prepared by the manufacturer containing information with respect to the production and/or control of pharmaceutical manufacturing operations carried out at a named site, and to any closely integrated operations at adjacent and/or nearby buildings. If only part of a pharmaceutical operation is carried out.

A supply of power intended to simulate solar array output at specific instantaneous solar radiation values.

An assembly of solar module(s), electrical cabling, support structure, control and energy storage (e.g. battery, water/ice or PCM) complying with specification WHO/PQS/E003/PV 01.

The minimum average daily solar radiation on the plane of the solar array that is required to properly power the solar refrigerator, or combined refrigerator and water-pack freezer, expressed in kWh/m²/day.

the quality standard (that is, tests, analytical procedures and acceptance criteria) provided in an approved application to confirm the quality of antigens (drug substances), final products (drug products), intermediates, raw materials, reagents, components, in-process materials, container closure systems and other materials used in the production of the antigen (drug substance) or final product (drug product). For the purpose of this definition, acceptance criteria mean numerical limits, ranges or qualitative criteria for the applied tests. It serves as a basis for quality evaluation.

A list of tests, references to analytical procedures and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. “Conformance to specification” means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

Instrument for measuring time‒temperature indicator optical density (OD) values.

The ability of a drug to retain its properties within specified limits throughout its shelf life. The following aspects of stability are to be considered: chemical, physical, microbiological and biopharmaceutical.

Long-term and accelerated (and intermediate) studies undertaken on primary and/or commitment batches according to a prescribed stability protocol to establish or confirm the retest period (or shelf life) of an active pharmaceutical ingredient or the shelf life of a finished pharmaceutical product.

A series of tests designed to obtain information on the stability of a pharmaceutical product in order to define its shelf life and utilization period under specified packaging and storage conditions.

Solar power system capable of independently powering 100% of all electrical management system electrical needs.

Common electrical connectors including all USB receptacles, 12 volts of direct current (VDC) receptacles as used in vehicles and 120/230 VAC (volts of alternating current) receptacles as used in buildings and electrical generators.

An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material (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 production documentation.

Normative references about the product manufacturing process and product performance, quality and safety. In evaluating immunizations devices for prequalification, WHO applies standards defined by the International Organization for Standarizationm (ISO) wherever possible. In addition to ISO standards, WHO draws on the standards of other relevant international or national bodies in different parts of the world.

The appearance of the active surface of the indicator at the time when the indicator is activated.

Any material used at the beginning of the manufacturing process, as described in a marketing authorization or product licence. Generally, the term refers to a substance of defined chemical properties and structure that contributes an important and/or significant structural element (or elements) to the active substance (for example in the case of vaccines, synthetic peptides, synthetic glycans and starting materials for adjuvants). The starting material for an antigen (drug substance) obtained from a biological source is considered to consist of: (a)  cells; (b) microorganisms; (c) plants, plant parts, macroscopic fungi or algae; or (d) animal tissues, organs or body fluid from which the antigen (drug substance) is derived.

In relation to non-replaceable batteries, the period measured from the date of delivery of the device to the sender to the time at which the ‘start’ function may be activated and a sufficient operating life would remain.

A regulatory authority which is:

a. a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency

or an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015)

or a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).

Note: This interim definition is currently being revised.

A multi-dose container consisting of two layers, usually provided with perforations, suitable for containing single doses of solid or semi-solid preparations. Blisters are excluded.

Commonly used term for employee of a manufacturing company that is undergoing inspection who is presented as possessing expertise in a particular area or subject and who can therefore answer related questions and requests for futher information made by the inspection team.

Substandard medicines are pharmaceutical products that fail to meet either their quality standards or their specifications, or both. Each pharmaceutical product that a manufacturer produces has to comply with quality assurance standards and specifications, at release and throughout its shelf life, according to the requirements of the territory of use. Normally, these standards and specifi cations are reviewed, assessed and approved by the applicable national or regional medicines regulatory authority before the product is authorized for marketing.

Summary of product characteristics approved by the competent authority. The information may alternatively be presented in the container or package label.

Written request submitted to the national regulatory authority (NRA) to approve a change in the original application for a marketing authorization (MA) (or product licence) or any other notification to add to (that is, supplement) the information in the original MA or product licence file. A prior approval supplement is a supplement requiring approval from the NRA prior to implementation of the change. May also be referred to as “change application dossier”.

A person providing pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Where possible, suppliers should be authorized by a competent authority.

Any electricity a solar direct device appliance cannot use because:

the appliance does not require electricity at that instant

electricity being generated is insufficient to power the appliance at that instant

electricity is powering the appliance and there is surplus electricity that the appliance cannot use at that instant.

Continuous, systematic collection, analysis and interpretation of health-related data needed forthe planning, implementation, and evaluation of public health practice.

The local or remote programmable electronic temperature and event logging system specified in WHO/PQS/E006 performance specifications.