Note : the following definitions are best suited to the QUAMED business environment. WHO has compiled the definitions of all technical terms used in its Technical Report Series and guidelines in the SAQ Terminology database available on the WHO website: http://www.who.int/medicines/services/expertcommittees/pharmprep/20111208_QASterminologyDB.pdf.
Active Pharmaceutical Ingredients (API)
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage forms. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
An independent and objective activity designed to add value and improve an organization’s operations by helping an organization to accomplish its objectives by using a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control, and governance processes.
Essential Pharmaceutical Products
Those pharmaceutical products that satisfy the health care needs of the majority of the population. WHO’s Expert Committee on the Selection and Use of Essential Medicines updates the WHO Model List of Essential Medicines at two-year intervals. Each country may use this model to generate its own list of essential pharmaceutical products.
Finished Pharmaceutical Product (FPP)
A finished dosage form of a pharmaceutical product, which has undergone all stages of production, including packaging in its final container and labelling.
The term generic product has somewhat different meanings in different jurisdictions. The use of this term is therefore avoided as far as possible, and the term multisource pharmaceutical product (see below) is used instead. Generic products may be marketed either under the approved non-proprietary name or under a brand (proprietary) name. They may be marketed in dosage forms and/or strengths different from those of the innovator products (see below). 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 licence 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 APIs.
Global Harmonization Task Force (GHTF)
An international initiative to achieve greater uniformity between national medical device regulatory systems. GHTF member countries are specified on its website: www.ghtf.org.
Good distribution practices (GDP)
That part of quality assurance that ensures that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded pharmaceutical products.
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 marketing authorization.
Good Storage Practices (GSP)
That part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof.
International Conference on Harmonization (ICH)
An initiative involving regulatory bodies and pharmaceutical industry experts that was established to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration. ICH member countries are specified on its website: http://www.ich.org.
International Non-proprietary Name (INN)
The shortened scientific name based on the active ingredient. WHO is responsible for assigning INNs to pharmaceutical substances.
A company that produces, packages, repackages, labels and/or relabels pharmaceutical products.
A legal document issued by the competent medicine regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality. It must set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose (using INNs or national generic names where they exist), the shelf life and storage conditions, and packaging characteristics. It specifies the information on which authorization is based (e.g. “The product(s) must conform to all the details provided in your application and as modified in subsequent correspondence.”). It also contains the product information approved for health professionals and the public, the sales category, the name and address of the holder of the authorization, and the period of validity of the authorization. Once a product has been given marketing authorization, it is included on a list of authorized products – the register – and is often said to be “registered” or to “have registration”. Market authorization may occasionally also be referred to as a “licence” or “product licence”.
Any instrument, apparatus, implement, machine, appliance,implant, in vitro reagent or calibrator, software, material or other similar or related article:
- Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease,
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- Investigation, replacement, modification, or support of the anatomy or of a physiological process,
- Supporting or sustaining life,
- Control of conception,
- Disinfection of medical devices,
- Providing information for medical or diagnostic purposes by means of in vitroexamination of specimens derived from the human body;
- Andwhich does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
Multi Source Pharmaceutical Product
Pharmaceutically equivalent or pharmaceutically alternative products that may or may not be therapeutically equivalent. Multisource pharmaceutical products that are therapeutically equivalent are interchangeable.
Pharmaceutical Inspection Cooperation 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 provide together an active and constructive co-operation in the field of GMP.PIC/S’ mission is “to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products.”
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.
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.
Prequalification is required for all pharmaceutical products regardless of their composition and place of manufacture or registration, but the amount and type of information requested from the supplier for use in the assessment by the procurement agency may differ.
Procurement Agency (PA)
A procurement agency in the context of this document 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.
Quality Assurance (QA)
Quality assurance is a wide-ranging concept which covers all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made to ensure that pharmaceutical products are of the quality required for their intended use.
Quality Control (QC)
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.
Stringent Drug Regulatory Authority (SRA)
A stringent regulatory authority is: – the medicines regulatory authority in a country which is: (a) a member of the International Conference on Harmonisation (ICH) (European Union (EU) Japan and the United States of America); or (b) an ICH Observer, being the European Free Trade Association (EFTA) as represented by Swiss Medic and Health Canada (as may be updated from time to time);or (c) a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement including Australia, Iceland, Liechtenstein and Norway (as may be updated from time to time); and – only in relation to good manufacturing practices (GMP) inspections: a medicine regulatory authority that is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as specified on its website).
Stringent Inspection Body (SIB)
A Stringent Inspection Body is: (a) an inspection body of the regulatory authority of a member of the ICH ; or (b) an inspection body of the regulatory authority or an organisation of an ICH observer (WHO, EFTA, Canada) ; or (c) a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement including Australia, Iceland, Liechtenstein and Norway; or (d) a regulatory authority participating or partner of the PIC/S.
(QUAMED glossary, www.quamed.org)
A person or entity engaged in the activity of providing products and/or services.
WHO Prequalification Programme (WHO PQP)
The programme managed by WHO which prequalifies medicines, Active Pharmaceutical Ingredients, vaccines, diagnostics, injection devices and quality control laboratories. http://apps.who.int/prequal/(for medicines, API, QC laboratories)http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/(for vaccines)http://www.who.int/diagnostics_laboratory/evaluations/en/(for diagnostics)http://www.who.int/immunization_standards/vaccine_quality/pqs_prequalified_devices_e08/en/index.html(for injection devices)