Glossary of terms

Abortion

Termination of a pregnancy; an abortion may be spontaneous (miscarriage) or induced by medical or surgical methods.
 

Active pharmaceutical ingredient (API)

An active pharmaceutical ingredient (API) is the ingredient in a finished pharmaceutical product (FPP) that is responsible for its pharmacological activity. Some products may contain more than one active ingredient.
 

Batch

A batch is a specific, identified amount of finished pharmaceutical product (FPP) manufactured in a unit of time or quantity in a manner that assures it having uniform character and quality within specified limits. Each batch is given a discrete batch number and is associated with a specific shelf life (see below). 'A lot' is usually used interchangeably with 'a batch'. 
 

Certificate of analysis

The list of test procedures applied to a particular sample with the results obtained and the acceptance criteria applied. It indicates whether or not the sample complies with the specification for that sample.
 

Contract manufacturer

A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer. A manufacturer undertaking all aspects of manufacturing of a finished pharmaceutical product for another agency to be sold under that agency’s brand name.
 

Co-packaged product (combipack)

A product consisting of two or more separate pharmaceutical products in their final dosage form that are packaged together for distribution to patients in the co-packaging. In the context of mifepristone and misoprostol, when they are co-packaged in a single pack, it is often referred to as a combipack.
 

Counterfeit pharmaceutical product

A pharmaceutical product which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can occur with both branded and generic products, and counterfeit pharmaceutical products may include products with the correct ingredients, with the wrong ingredients, without active ingredients, with an incorrect quantity of active ingredient or with fake packaging.
 

Date of manufacture

A date fixed for the individual batch, indicating the completion date of the manufacture. It is normally expressed by a month and a year. 
 

Ectopic pregnancy

A pregnancy that has implanted outside of the uterus, most commonly in the fallopian tube.
 

Expert Review Panel (ERP) Process

The ERP process was developed as an interim mechanism in cases when procurement of certain medicines is necessary and there are not enough reproductive health medicines available that are WHO prequalified or SRA approved. The ERP assesses the quality standards of the requesting manufacturers and decides whether or not to recommend procurement of the medicines in question for a period of 18 months. In some cases, this period may be extended for an additional 12 months after reassessment of a new submission of the product.
 

Expiry date

The date after which a compounded preparation should not be stored, transported or used; the date is determined from the date or time the preparation is compounded. It is also known as beyond-use date. It is usually expressed in months and years and dermined from the stability studies undertaken by the manufacturer and which are appropriate for the geographic region in which the product is to be sold. 
 

Finished pharmaceutical product (FPP)

A finished dosage form of a pharmaceutical product that has undergone all stages of manufacture, including packaging in its final container and labelling.
 

Generic product

The term generic product has somewhat different meanings in different jurisdictions. The use of this term is therefore avoided if possible; the term 'multisource pharmaceutical product' is preferred. Generic products may be marketed either under the approved nonproprietary name or under a brand (proprietary) name. They may be marketed in dosage forms and/or strengths different from those of the innovator products in some jurisdictions. Where the term 'generic product' is used, it means a pharmaceutical product, usually intended to be interchangeable with the innovator product, which is usually manufactured without a license from the innovator company and marketed after expiry of the patent or other exclusivity rights. The term should not be confused with generic names for active pharmaceutical ingredients.
 

Gestational age 

The number of days of pregnancy that has lapsed since the first day of the last menstrual period (LMP). Before an abortion, the gestational age must be calculated to ensure that the correct doses of medication are used to achieve a safe abortion. It can be determined by clinical examination or ultrasound.
 

Good manufacturing practice (GMP)

The 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 marketing authorization. 
 
Compliance with current GMP (c-GMP) is normally determined as part of the inspection and review by the regulatory agency authorizing marketing approval in its territory. It is not usually a process that is certified, although some stringent regulatory agencies will supply a certificate of compliance if requested. Some purchasing organizations undertake independent audits of GMP but these cannot be certified as conforming to international standards. 
 
Many manufacturers claim to meet WHO GMP, often due to national or regional authorization processes that inform the manufacturer that they meet WHO GMP but in reality may not be c-GMP. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) also plays a role in harmonizing GMP requirements and assisting in improving the capability of national regulatory agencies. 
 

Innovator product

Generally the pharmaceutical product which was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality according to requirements at the time of the authorization. 
 

Interchangeable pharmaceutical product

An interchangeable pharmaceutical product is one which is therapeutically equivalent to a comparator product and can be interchanged with the comparator in clinical practice.
 

Last menstrual period (LMP)  

Refers to the first date of their last menstrual period and is commonly used to estimate gestational age.  The LMP is usually two weeks prior to the date of conception. If a woman has irregular menstrual cycles, then the LMP does NOT accurately estimate the gestational age and  adjustments need to be made to arrive at a more accurate estimate of gestational age.
 

Long-term stability studies

Experiments on the physical, chemical, biological, biopharmaceutical and microbiological characteristics of an active pharmaceutical ingredient or finished pharmaceutical product, 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 re-test period or the shelf life, to confirm the projected re-test period and shelf life, and to recommend storage conditions.
 

Lot

The term "lot" is generally used interchangeably with a batch (see above).
 

Manufacture

All operations of purchase of materials for production and precursor products, production itself, quality control, release, storage and distribution of pharmaceutical products, and the related controls.
 

Manufacturer

A company that carries out operations such as production, packaging, repackaging, labelling and relabelling of pharmaceuticals.
 

Marketing authorization

Also referred to as product license or registration certificate. A legal document issued by the competent medicines regulatory authority that authorizes the marketing or free distribution of a medical product in the respective country after evaluation of safety, efficacy and quality. It establishes the detailed composition and formulation of the product and the quality requirements for the product and its ingredients. It also includes details of the packaging, labelling, storage conditions, shelf life and approved conditions of use.
 

Marketing authorization holder

Any person or entity with the legal responsibility for a product on the market after registration/approval. Particularly when the product is imported from another country, the distributor is often the responsible entity that applies for and holds the marketing authorization. 
 

Medical abortion (also known as medication abortion)

An abortion performed using either one or a combination of medications that end the pregnancy and/or expel it from the uterus without any instrumentation of the uterus.  Most commonly, such abortion procedures use either a combination of mifepristone and misoprostol or repeated doses of misoprostol. 
 

Mifepristone

A drug that blocks the effect of the hormone progesterone and causes separation of the pregnancy from the uterine wall. It also softens the cervix, making expulsion of the pregnancy easier. This is the first of two medications that are typically used for the medical abortion. It has not been shown to be effective if the pregnancy is outside the uterus (an ectopic pregnancy).
 

Misoprostol

A medication that causes the cervix to become soft and the uterus to contract and empty out its contents. This is one of the two drugs used in combination to induce abortion, although where mifepristone is unavailable, it may be used alone.
 

National regulatory agency (medicines regulatory authority)

A national body that administers the full spectrum of medicine regulatory activities, including at least all of the following functions in conformity with national legislation:
 
  • marketing authorization of new products and variations of existing products
  • quality control laboratory testing
  • monitoring of adverse drug reactions
  • provision of information on medicines and promotion of rational use of medicines
  • good manufacturing practice inspections and licensing of manufacturers, wholesalers and distribution channels
  • enforcement operations
  • monitoring of drug use
 
National regulatory agencies have considerably different competences, many having limited funding and staff, and cannot provide a full product assessment. As such, many procurers may only consider purchase of a “quality-assured” product that has been approved by a Stringent Regulatory Agency (SRA) or prequalified by the World Health Organization (WHO).   
 

Multisource (generic) pharmaceutical product

Multisource pharmaceutical products are pharmacologically equivalent products that may or may not be therapeutically equivalent. Multisource pharmaceutical products that are therapeutically equivalent are interchangeable.
 

Normal storage conditions

Storage in dry, well-ventilated premises at a temperature of 15–25 °C or, depending on climatic conditions, up to 30 °C. Extraneous odours, other indications of contamination, and intense light are not considered 'normal' conditions.
 

Off-label use

Use of a medicine by a licensed prescriber for an indication not included in its regulatory authorization. The practice is legal in many countries but it is illegal for a company to promote off-label use to prescribers.
 

Ongoing stability study

The study carried out by the manufacturer on production batches according to a predetermined schedule in order to monitor, confirm and extend the projected re-test period (or shelf life) of the active pharmaceutical ingredient, or confirm or extend the shelf life of the finished pharmaceutical product.
 

Over-branded products

A supplier may reach agreement with a manufacturer to use that manufacturer’s product under its own brand name. This is a practice usually adopted by social marketing organizations (SMOs, see below). An over-branded product will require specific regulatory authorization in most countries.  
 

Pack size 

The number of tablets in each packet.
 

Pregnancy 

The period during which a woman gestates a developing embryo or fetus in her uterus.
 

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), are two international instruments between countries and pharmaceutical inspection authorities, which together provide an active and constructive co-operation in the field of GMP. PIC/S' mission is "to lead the international development, implementation and maintenance of harmonized Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products."
 

Pharmacopoeia

An official publication that comprises a collection of procedures for analysis and specifications for the determination of pharmaceutical substances, excipients and dosage forms; such publication is intended to serve as source material for reference by any Member State wishing to establish pharmaceutical requirements. A pharmacopoeia, or any part of it, shall have legal status, whenever a national or regional authority expressly introduces it into appropriate legislation.
 

Prequalification

The activities undertaken in defining a product or service need, seeking expressions of interest from enterprises to supply the product or service, and examining the product or service offered against the specification and the facility where the product or service is prepared or stored and distributed against common standards. The examination of the product or service and of the facility is performed by trained and qualified assessors and inspectors against common standards.
 

Procurement

The process of purchasing or otherwise acquiring any pharmaceutical product, vaccine, or nutraceutical for human use. 
 

Procurement agency

Any organization which is purchasing or otherwise acquiring any pharmaceutical product for human use. Normally, it will be a not-for-profit organization, a non-governmental organization or a United Nations organization. 
 

Product recall

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.
 

Quality

The suitability of either an active pharmaceutical ingredient or a pharmaceutical product for its intended use. This term includes such attributes as the identity, strength and purity.
 

Quality assurance

“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 use. Quality assurance therefore incorporates good manufacturing practice and other factors, including those outside the scope of this guide such as product design and development.
 

Quality control

All measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that raw materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.
 

Quality risk management

A systematic process for the assessment, control, communication, and review of risks to the quality of the pharmaceutical product across the product life-cycle.
 

Registration

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

Risk assessment

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.
 

Sample collected in a quality survey

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.
 

Sampling plan

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.
 

Shelf life

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 and is based on results obtained from relevant stability studies.
 

Social marketing

Social marketing is a strategy uses marketing concepts, such as product design, appropriate pricing, sales and distribution, and communications, to influence behaviors that benefit individuals and communities for the greater good. 
 

Social marketing organizations (SMOs)

Organizations providing products through social marketing. They are usually not-for-profit, non-governmental organizations (NGOs) and are dependent on external funding to provide products at a subsidized price. 
 

Stability

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

Stability studies (stability testing)

Long-term and accelerated (and intermediate) studies undertaken on the 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. The conditions of the stability studies are determined by the climatological conditions of the markets in which the product is to be used. In the case of misoprostol, which is particularly sensitive to humidity, since its use is often in tropical countries, the accelerated stability studies should be undertaken for a minimum of six months at 40°C and 75% relative humidity.  
 

Stringent regulatory agency

A specified group of national regulatory agencies providing a significant and high-level review of all aspects of quality assurance and safety and efficacy of a specific product. In 2017, WHO’s Prequalification Programme revised its definition of a stringent regulatory agency to be an authority that is: 
 
a) a member of ICH prior to 23 October 2015, namely: the US Food and Drug Administration, the European Commission and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or 
 
b) an ICH observer prior to 23 October 2015, namely: the European Free Trade Association, as represented by Swissmedic and Health Canada; or 
 
c) a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement prior to 23 October 2015, namely: Australia, Iceland, Liechtenstein and Norway.
 

Substandard medicines

Substandard medicines are pharmaceutical products that fail to meet either their quality standards or their specifications, or both. Each 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 specifications are reviewed, assessed and approved by the applicable national or regional medicines regulatory authority before the product is authorized for marketing.
 

Supplier

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.
 

WHO Prequalification Programme (WHO PQP) 

The programme managed by WHO which prequalifies specific groups of medicines (such as medicines for reproductive health), active pharmaceutical ingredients, vaccines, diagnostics, injection devices and quality control laboratories. The term “prequalification” refers to prequalification of a product for purchase by the United Nations and its agencies. However, for specific groups of medicines, such as those used for reproductive health, “prequalification” by WHO has become accepted as an option to demonstrate that a product is quality-assured for manufacturers that do not wish to market their products in countries with stringent regulatory agencies (see above).