Definitions and technical terms
Batch
A defined quantity of starting material, packaging material or product processed in a single process or series of processes so that it is expected to be homogeneous.
Batch number
A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.
Consignment (or delivery)
The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.
Container
The material employed in the packaging of a pharmaceutical product. Containers include primary, secondary and transportation containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product.
Contamination
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material, intermediate or pharmaceutical product during handling, production, sampling, packaging or repackaging, storage or transport.
Counterfeit
À counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products and may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.
Cross-contamination
Contamination of a starting material, intermediate product or finished product, with another starting material or product during production.
Distribution
The division and movement of pharmaceutical products from the premises of the manufacturer of such products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.
Expiry date
The date given on the individual container (usually on the label) of a 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.
Labeling
Process of identifying a product, by choosing and attaching the primary and secondary packaging (container) with the right label which includes all needed information regarding the product or material.
Manufacture
All operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls.
Material
A general term used to denote starting materials (active pharmaceutical ingredients and excipients), reagents, solvents, process aids, intermediates, packaging materials and labeling materials.
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.
Pharmaceutical 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.
Product recall
Product recall is a process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product. The recall might be initiated by the manufacturer/importer/ distributor or a responsible agency.
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 control
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.
Quality system
An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality.
Quarantine
The status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.
Shelf-life
The period of time during which a finished pharmaceutical product, if stored correctly, 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.
Standard operating procedure (SOP)
An authorized, written procedure giving instructions for performing operations not necessarily specific to a given product but of a more general nature (e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection).
Storage
The storing of pharmaceutical products up to the point of use.
Validation
A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting pre-determined acceptance criteria.
Vehicle
Vehicle refers to trucks, vans, buses, minibuses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey pharmaceutical products.
Supplier:
A person or party which provide the concerned establishment, pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Suppliers should be authorized by a competent authority.
Retest date:
The date when a material should be re-examined to ensure that it is still suitable for use.
Normal Storage Conditions
Means to practice storage under environmental conditions described as dry with a good ventilation within temperature degrees range between 15 to 25 degrees Celsius that could extend to 30 degrees Celsius as marginal limit. The storage environment should be protected from any external vapors or smells, contamination factors and extensive direct light.
Packaging material
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.
Specific Storage conditions:
Some pharmaceutical products require specific conditions to be stored within, and needs special instructions for storage handling and methods.
Interpretation of instructions included on the product label:
Not to exceed 30 Degree Celsius: means to store within the range from +2 to +30 Degrees Celsius.
Not to exceed 25 Degree Celsius: means to store within the range from +2 to +25 Degrees Celsius
Not to exceed 15 Degree Celsius: means to store within the range from +2 to +15 Degrees Celsius.
Not to exceed 8 Degree Celsius: means to store within the range from +2 to +8 Degrees Celsius.
Do not store below 8 Degree Celsius: means to store within the range from +8 to +25 Degrees Celsius.
The product should be protected from humidity: means to protect it from conditions where humidity exceeds 60%, and should be kept in a humidity resistant container.
Keep away from light: means that should be stored in places not exposed to light. It should be kept in light proof containers.
