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 so used, becomes an active ingredient of that pharmaceutical dosage form. 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.
airlock An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for use either by people or for goods and/or equipment.
authorized person The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that ry.
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 is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the
batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in 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, its batch records
and corresponding certificates of analysis, etc.
batch records All documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.
bulk product Any product that has completed all processing stages up to, but not including, final packaging.
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.
clean area An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce
the introduction, generation, and retention of contaminants within the area.
consignment (or delivery). The quantity of a pharmaceutical or pharmaceuticals, 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.
contamination The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or
intermediate during production, sampling, packaging or repackaging, storage or transport.
critical operation An operation in the manufacturing process that may cause variation in the quality of the pharmaceutical product.
cross-contamination Contamination of a starting material, intermediate product or finished product with another starting material or product during
production.
finished product A finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling.
in-process control Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product
conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.
