Annex 5 WHO good distribution practices for pharmaceutical products

Containers are referred to as primary if they are intended to be in directcontact with the product. Secondary containers are not intended to be indirect contact with the product.contaminationThe undesired introduction of impurities of a chemical or microbiologicalnature, or of foreign matter, into or on to a starting material, intermediate orpharmaceutical product during handling, production, sampling, packagingor repackaging, storage or transportation.contractBusiness agreement for the supply of goods or performance of work at aspecified price.counterfeit pharmaceutical productA pharmaceutical product which is deliberately and fraudulently mislabelledwith respect to identity and/or source. Counterfeiting can apply to bothbranded and generic products, and counterfeit pharmaceutical products mayinclude products with the correct ingredients, with the wrong ingredients,without active ingredients, with an incorrect quantity of active ingredientor with fake packaging.cross-contaminationContamination of a starting material, intermediate product or finishedpharmaceutical product with another starting material or product duringproduction, storage and transportation.distributionThe procuring, purchasing, holding, storing, selling, supplying, importing,exporting, or movement of pharmaceutical products, with the exception ofthe dispensing or providing pharmaceutical products directly to a patient orhis or her agent.expiry dateThe date given on the individual container (usually on the label) of apharmaceutical product up to and including the date on which the product isexpected to remain within specifications, if stored correctly. It is establishedfor each batch by adding the shelf-life to the date of manufacture.fi rst expiry/fi rst out (FEFO)A distribution procedure that ensures that the stock with the earliest expirydate is distributed and/or used before an identical stock item with a laterexpiry date is distributed and/or used.239