The definitions given below apply specifically to the terms as used in these guidelines; they may have different meanings in other contexts.
A defined quantity of any drug processed in a single process or series of processes such that it is reasonably expected to be uniform in character and quality.
A document containing information, as set out in Appendix 3 of the Guidelines for Use of the WHO Certification Scheme (16), will normally be issued for each batch by the manufacturer. Furthermore, a batch certificate may be exceptionally validated or issued by the competent authority of the exporting country, particularly for vaccines, sera and other biological products. The batch certificate accompanies every major consignment.
Drug (medicine, pharmaceutical product, pharmaceutical)1
1 The terms "drug", "medicine", "pharmaceutical product" and "pharmaceutical" are used interchangeably in these guidelines.
Any substance or mixture of substances that is manufactured for sale or distribution, offered for sale, sold, supplied or presented for use in:
(i) the treatment, mitigation, cure, prevention or diagnosis of disease, an abnormal physical state or the symptoms thereof in humans or animals
(ii) normal physiological conditions in humans or animals; or
(iii) the restoration, correction or modification of organic functions in humans or animals, or any substance in a pharmaceutical product that is used to modify or explore physiological systems or pathological states for the benefit of the recipient.
Drug regulatory authority
The national agency responsible for the registration of and other regulatory activities concerning pharmaceutical products.
Good manufacturing practices
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/product licence.
All operations of purchase of materials and products, production, quality control, release, storage, shipment of finished products and the related controls.
A company that carries out at least one step of manufacture.
An official document issued by the competent drug 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 international nonproprietary names or national generic names where they exist), the shelf-life and storage conditions and packaging characteristics. It also contains information approved for health professionals and the public, me sales category, the name and address of the licence holder, and the period of validity of the licence.
National drug distribution channels
Facilities through which drug products are distributed within a country.
All operations, including filling and labelling, which a bulk product has to undergo in order to become a finished product. Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container.
The holder of a degree or diploma in pharmacy from a recognized higher institution of learning who is registered or licensed to practise pharmacy.
That part of good manufacturing practice concerned with sampling, specifications and testing and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.