intermediate product. Partly processed product that must undergo further manufacturing steps before it becomes a bulk product.
large-volume parenterals. Sterile solutions intended for parenteral application with a volume of 100 ml or more in one container of the finished
dosage form.
manufacture. All operations of purchase of materials and products, production, quality control (QC), release, storage and distribution of pharmaceutical products, and the related controls.
manufacturer. A company that carries out operations such as production, packaging, repackaging, labelling and relabelling of pharmaceuticals.
marketing authorization (product licence, registration certificate). A legal document issued by the competent medicines regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life.
master formula. A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a
description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including
the in-process controls.
master record. A document or set of documents that serve as a basis for the batch documentation (blank batch record).
packaging. All operations, including filling and labelling, that a bulk product has to undergo in order to become a finished product. Filling of a sterile product under aseptic conditions or a product intended to be terminally sterilized, would not normally be regarded as part of packaging.
packaging material. Any material, including printed material, employed in the packaging of a pharmaceutical, 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.
pharmaceutical product. Any material or product intended for human or veterinary use 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 the exporting state and/or the importing state.
production. All operations involved in the preparation of a pharmaceutical product, receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product.
qualification. Action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. The meaning
of the word “validation” is sometimes extended to incorporate the concept of qualification.
