Glossary
The definitions given below apply to the terms as used in these guidelines. They may have different meanings in other contexts.

Active Pharmaceutical Ingredient (API)
Any substance or mixture of substances intended to be used in themanufacture of a pharmaceutical dosage form and that, when so used,becomes an active ingredient of that pharmaceutical dosage form.Such substances are intended to furnish pharmacological activity orother direct effect in the diagnosis, cure, mitigation, treatment, orprevention of disease or to affect the structure and function of thebody.

Agreement
Arrangement undertaken by and legally binding on parties.

Batch (or lot)
A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it couldbe expected to be homogeneous. It may sometimes be necessary todivide a batch into a number of sub-batches, which are later broughttogether to form a final homogeneous batch. In the case of terminalsterilization, the batch size is determined by the capacity of theautoclave. In continuous manufacture, the batch must correspond toa defined fraction of the production, characterized by its intendedhomogeneity. The batch size can be defined either as a fixed quantity
Gor as the amount produced during a fixed time interval.
 
Batch Number (or Lot Number)
A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, the batch records, the certificates of analysis, etc.

Calibration
The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.

Certificate Of Analysis (COA)
A document listing the results of testing a representative sample drawn from the batch to be delivered. A COA should be equivalent to the WHO Model COA (1)

Consignment
The quantity of a pharmaceutical starting material 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.

Contract
Business agreement for supply of goods or performance of work at a specified price.

Earliest Expiry/First Out Principle Concept (EEFO)
A distribution procedure to ensure that the stock with the earliest expiry date is distributed and/or utilized before an identical stock item with a later expiry date is distributed and/or utilized.

Excipient
A substance or compound, other than the active pharmaceutical ingredient and packaging materials, that is intended or designated to be used in the manufacture of a pharmaceutical product.

Expiry Date
The expiry date displayed on the container of a pharmaceutical starting material is the date up to and including which the pharmaceutical starting material is expected to remain within specification if stored correctly. It is established for every batch by adding the shelf-life to the date of manufacture.  

First In/First Out Principle Concept (FIFO)
A distribution procedure to ensure that the oldest stock is distributed and/or utilized before a newer and identical stock item is distributed and/or utilized.

Good Manufacturing Practice (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.

Homogeneous Material
Material of uniform consistency and composition throughout a batch.

In-Process Control
Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the material conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.

Intermediate
Partly processed material that must undergo further manufacturing steps before it becomes a bulk product.

Labelling
The action involving the selection of the correct label, with the required information, followed by line-clearance and application of the label.

Manufacture
All operations of purchase of materials, production, quality control, release, storage, and distribution of pharmaceutical starting materials, and the related controls.

Original Manufacturer
Person or company manufacturing a material to the stage at which it is designated as a pharmaceutical starting material.

Pharmaceutical Starting Material
A pharmaceutical starting material is an active pharmaceutical ingredient (API) or an excipient intended or designated for use in the production of a pharmaceutical product.

Production
All operations involved in the preparation of a pharmaceutical start-Ging material, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished pharmaceutical starting materials.

Quality Assurance
A wide-ranging concept covering all matters that individually or collectively influence the quality of a product, including pharmaceutical starting materials. It is the totality of the arrangements made with the object of ensuring that pharmaceutical starting materials and pharmaceutical products are of the quality required for their intended use.

Quality Control
All measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that raw materials, intermediates, packaging materials and finished pharmaceutical starting materials conform to established specifications for identity, strength, purity and other characteristics.

Quarantine
The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.

Recall
A process for withdrawing or removing a pharmaceutical material from the distribution chain because of defects in the materials or complaints of a serious nature. The recall might be initiated by the manufacturer/importer/distributor or a responsible agency.

Relabelling
The process of putting a new label on the material (see also labelling)

Repackaging
The action of changing the packaging of the material.

Retest Date
The date when a material should be re-examined to ensure that it is still suitable for use.

Sampling
Operations designed to obtain a representative portion of a pharmaceutical starting material based on an appropriate statistical procedure, for a defined purpose, e.g. acceptance of consignments, batch release, etc.

Skip Lot (Periodic) Testing
The performance of specified tests at release on preselected batches and/or at predetermined intervals, rather than on a batch-to-batch basis, with the understanding that those batches not tested must stillmeet all the acceptance criteria established for that product. Thisrepresents a less than full schedule of testing and should thereforebe justified, presented to, and approved by, the regulatory authoritybefore implementation. When tested, any failure of the starting material to meet the acceptance criteria established for the periodic (skiplot) test should be handled by proper notification of the appropriateregulatory authority (authorities). If these data demonstrate a need torestore routine testing, then batch-by-batch release testing should bereinstated.

Supplier
Person or company providing pharmaceutical starting materials onrequest. Suppliers may be distributors, manufacturers, traders, etc.

Validation
The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expectedresults.