Glossary

All operations, including filling and labelling, that a bulk product has to undergo in order to become a finished product. Filling of a sterile product under aseptic conditions or a product intended to be terminally sterilized, would not normally be regarded as part of packaging.

Any material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.

Cooling or heat transfer driven exclusively by temperature differential that occurs spontaneously through and between the components of the appliance, its content and the ambient temperature.

Products are pharmaceutical alternative(s) if they contain the same active pharmaceutical moiety or moieties but differ in dosage form (e.g. tablets versus capsules), strength, and/or chemical form (e.g. different salts or different esters). Pharmaceutical alternatives deliver the same active moiety by the same route of administration but are otherwise not pharmaceutically equivalent. They may or may not be bioequivalent or therapeutically equivalent to the comparator product.

The physical form in which a medicine is presented; the name of a dosage form combines its physical form and the intended route of administration, e.g. a tablet (to be swallowed), oral suspension (liquid suspension of solid particles intended for oral intake and swallowing).

Products are pharmaceutical equivalents if they contain the same molar amount of the same active pharmaceutical ingredients (APIs) in the same dosage form, if they meet comparable standards and if they are intended to be administered by the same route. Pharmaceutical equivalence does not necessarily imply therapeutic equivalence, as differences in the API solid state properties, the excipients and/or the manufacturing process and other variables can lead to differences in product performance.

A substance, other than the active pharmaceutical ingredient, which has been appropriately evaluated for safety and is included in a medicines delivery system to:

aid in the processing of the medicines delivery system during its manufacture

protect, support or enhance stability, bioavailability or patient acceptability

assist in pharmaceutical product identification

enhance any other attribute of the overall safety and effectiveness of the medicine during its storage or use.

Any substance or combination of substances marketed or manufactured to be marketed for treating or preventing disease in human beings, or with a view to making a medical diagnosis in human beings, or to restoring, correcting or modifying physiological functions in human beings.

Any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials. This includes active pharmaceutical ingredients and pharmaceutical excipients.

The specificity of pharmacopoeial reference substances has been addressed in the introduction of ISO Guide: General requirements for the competence of reference material producers. “Pharmacopoeial standards and substances are established and distributed by pharmacopoeial authorities following the general principles of this Guide. It should be noted, however, that a different approach is used by the pharmacopoeial authorities to give the user the information provided by certificate of analysis and expiration dates” (*).*International Organization for Standardization. General requirements for the competence of reference material producers. 2006, ISO Guide 34.

A material, other than water, which changes state between solid and liquid or changes between two different solid crystallization states over a defined temperature range, absorbing or releasing heat during the phase change. This process is reversible and can be useful for thermal control in cold chain devices and products. PCM-based buffers must comply with PQS/E005/PCMC0.1– PCM specification for phase-change material containers.

A loss of power on one phase of a three-phase system.  Typically caused by a failed fuse, thermal overload, severed conductors, worn contacts or other types of mechanical failure.

A voltage variation in a three-phase system in which the voltage magnitudes and/or the phase angle differences between the different phases are not equal.  Expressed as the percentage calculated by dividing the maximum voltage deviation from the phase voltage average, by the three-phase voltage average.

A batch of an active pharmaceutical ingredient or finished pharmaceutical product manufactured by a procedure fully representative of and simulating that to be applied to a full production-scale batch. For example, for solid oral dosage forms, a pilot scale is generally, at a minimum, one-tenth that of a full production scale or 100 000 tablets or capsules, whichever is the larger; unless otherwise adequately justified.

These describe the various activities and courses of action adopted by WHO in fulfilling its responsibilities vis-à-vis prequalification of immunization devices. They are fully described in the standard operating procedures.

Standardized prequalification procedure of WHO to assess, in principle, whether candidate products:

meet WHO technical guidance on quality, safety and efficacy, including compliance with WHO's recommended standards for good clinical practice, good manufacturing practices, good laboratory practices and good distribution practices

adhere to the principles laid out in the WHO guidelines on the international packaging and shipping of vaccines

meet relevant operational packaging and presentation specifications, for the purpose of providing guidance to interested United Nations agencies and WHO Member States in their procurement decisions.

United Nations agencies and WHO Member States using information resulting from WHO prequalification should perform additional steps of qualification prior to purchasing such products, including ensuring financial stability and standing of the supplier, ability to supply the required quantities, security of the supply chain, pre-shipment quality control and other related aspects, including the registration status of the products to be procured.

Preventive actions are steps taken to eliminate the causes of undesirable nonconformities or situations that could occur, but have not yet done so. While corrective actions prevent recurrence, preventive actions prevent occurrence. See also corrective action. Both types of actions are intended to prevent nonconformities.

Activities associated with the upkeep of equipment to protect against normal wear and tear. This type of maintenance requires minimal skills and training and is usually scheduled for regular intervals (daily, weekly or monthly). On-site workers who have received appropriate training are responsible for preventive maintenance.

A batch of an active pharmaceutical ingredient or finished pharmaceutical product used in a stability study, from which stability data are submitted in a registration application for the purpose of establishing a retest peropd or shelf life.

Vial, ampoule, pre-filled device, plastic dispenser or tube containing vaccine or diluent.

Store which receives vaccine directly from the vaccine manufacturer.

The process of purchasing or otherwise acquiring any pharmaceutical product, vaccine, or nutraceuticals for human use. For the purpose of this website, procurement means the preselection of products and manufacturers through a procedure of qualification, including prequalification (see above) and continuous monitoring thereafter, purchase of the prequalified products from prequalified manufacturers (linked to the specific product) through defined purchasing mechanisms, storage and distribution.

A procurement agency in the context of this website is defined as any organization purchasing pharmaceutical products, vaccines, or other health sector goods or is otherwise involved in their prequalification (see above), purchasing, storage and distribution. With respect to immunization devices, a procurement agency is an organization that purchases the equipment covered in a WHO specification and provides the qualified supplier with details of the installation site(s).

Information on pharmaceutical products submitted by manufacturers or suppliers in any of the formats specified in the procurement agency’s guidelines (including product dossiers, product questionnaires or other formats) to obtain prequalification for the products.

Printed materials that accompany a prescription medicine and all labelling items, namely: (a) prescribing information (an instruction circular that provides product information on indication, dosage and administration, safety and efficacy, contraindications and warnings, along with a description of the product for health care providers (also referred to as “summary of product characteristics” or “package insert” in various countries); (b) patient labelling or consumer information; (c) inner label or container label; and (d) outer label or carton.

A process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product, complaints of serious adverse reactions to the product and/or concerns that the product is or may be counterfeit. The recall might be initiated by the manufacturer, importer, wholesaler, distributor or a responsible agency.

All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product.

A batch of an active pharmaceutical ingredient or finished pharmaceutical product manufactured at production scale by using production equipment in a production facility as specified in the application.

A document which states the background, rationale and objectives of the trial and describes its design, methodology and organization, including statistical considerations, and the conditions under which it is to be performed and managed. The protocol should be dated and signed by the investigator, the institution involved and the sponsor. It can also function as a contract.