(2003; 148 pages)
The definitions given below of some of the terms used in this document take into account the terminology of current regulations and recommendations.
active pharmaceutical ingredient (API)
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used in the production of a drug, becomes an active ingredient of that drug. 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.
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a starting material, or intermediate or finished product during production, sampling, packaging or repackaging, storage or transport.
Contamination of a starting material, intermediate product or finished product with another starting material or product during production.
A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a drug delivery system to:
- aid in the processing of the drug delivery system during its manufacture;
- protect, support or enhance stability, bioavailability, or patient acceptability;
- assist in product identification; or
- enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.
The date given on the individual container (usually on the label) of a drug product up to and including which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture.
The action involving the selection of the correct label, with the required information, followed by line clearance and application of the label.
All operations of purchase of materials and products, production, quality control, release, storage and distribution of finished products, and the related controls.
A general term used to denote starting materials (active pharmaceutical ingredients and excipients), reagents, solvents, process aids, intermediates, packaging materials and labelling materials.
Any material, including printed material, employed in the packaging of a pharmaceutical product, 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.
Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.
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.
The date when a material should be re-examined to ensure that it is still suitable for use.
The storing of pharmaceutical products and materials up to their point of use.
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.