quality unit(s). An organizational unit independent of production which fulfils both quality assurance (QA) and quality control (QC) responsibilities. This
can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.
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.
reconciliation. A comparison between the theoretical quantity and the actual quantity.
recovery. The introduction of all or part of previous batches (or of redistilled solvents and similar products) of the required quality into another
batch at a defined stage of manufacture. It includes the removal of impurities waste to obtain a pure substance or the recovery of used materials for a
separate use.
reprocessing. Subjecting all or part of a batch or lot of an in-process medicine, bulk process intermediate (final biological bulk intermediate) or bulk
product of a single batch or lot to a previous step in the validated manufacturing process due to failure to meet predetermined specifications. Reprocessing procedures are foreseen as occasionally necessary for biological medicines and, in such cases, are validated and pre-approved as part of the marketing authorization.
reworking. Subjecting an in-process or bulk process intermediate (final biological bulk intermediate) or final product of a single batch to an alternate manufacturing process due to a failure to meet predetermined specifications.Reworking is an unexpected occurrence and is not pre-approved as part of the marketing authorization.
self-contained area. Premises which provide complete and total separation of all aspects of an operation, including personnel and equipment movement, with well established procedures, controls and monitoring. This includes physical barriers as well as separate air-handling systems, but does not necessarily imply two distinct and separate buildings.
specification. A list of detailed requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.
standard operating procedure (SOP). An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material (e.g. equipment operation, maintenance and cleaning;validation; cleaning of premises and environmental control; sampling and inspection). Certain SOPs may be used to supplement product-specific master and batch production documentation.
starting material. Any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials.
validation. Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results (see also qualification).
