Section 3: Interpretation

In these Regulations, unless the context otherwise requires- "Act" means the National Drug Policy and Authority Act, Cap. 206; "active ingredient" means the antigenic substance or compound of an antigenic substance that induce specific responses in humans and animals against an infectious agent, its antigens or toxins; "active pharmaceutical ingredient" means any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of a human being or animals; "antigen" means a substance that when introduced into the body stimulates the production of an antibody and includes toxins, bacteria, foreign blood cells, and the cells of transplanted organs; "Authority" means the National Drug Authority; "batch" means a defined quantity of starting material, packaging material, or product processed in a single process or series of processes and in the case of continuous manufacture, means a defined fraction of the production, characterised by its intended homogeneity and includes lot; "batch number" means a distinctive combination of numbers or letters which specifically identifies a batch, on the labels, the batch records and the certificates of analysis of a manufactured product and includes lot number; "bulk product" means any product that completes all processing stages including the final packaging; "commitment batch" means the production batches of an active pharmaceutical ingredient or finished pharmaceutical product for which the stability studies are initiated or completed post-approval through a commitment made in a regulatory application; "diagnostic antigen" means a crude or purified fraction isolated from the microbial culture and intended for in vitro detection of an existing specific immune response or antibodies; "dosage form" means the physical form in which a product is prepared for administration to the recipient; "drug" includes a herbal medicine product which is packaged for commercial purposes; "generic product" means a drug which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference drug , and whose bioequivalence with the reference drug has been demonstrated by appropriate bioavailability studies; "herbal medicine product" means a finished, labeled herbal medicine product that contain as active ingredients aerial or underground parts of plants, or other plant materials, or a combination of these, whether in the crude state or as plant preparations and which may contain conventional excipients in addition to the active ingredients and may also contain by tradition, natural organic or inorganic ingredients which are not of plant origin; "immunological product" includes vaccines, immunoglobulins and antisera and in vitro diagnostic antigens; "indication" means the intended use of the product; "in-process control" means checks performed during production in order to monitor and if necessary, to adjust the process to ensure that a product conforms to its specifications and includes the control of the environment or equipment; "licensed person" means a person licensed under the Act; "manufacturer" means a person licensed to manufacture drugs or active pharmaceutical ingredients; "manufacturing process" means the transformation of starting materials into finished products including drug substances or pharmaceutical dosage forms through a single operation or a sequence of operations; "master cell seed" means a collection of aliquots of a preparation of cells, for use in the preparation of a product, distributed into containers in a single operation and processed together in a manner that ensures uniformity and processed and stored in a manner that ensures stability; "master formula" means 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 manufactured product as well as the processing instructions, including the in-process controls; "ongoing stability study" means the study carried out by a manufacturer on production batches according to a predetermined schedule in order to monitor, confirm and extend the projected re-test period or shelf-life of the active pharmaceutical ingredient, or to confirm or extend the shelf-life of the finished pharmaceutical product; "patent holder" means an owner of a patent for a particular product seeking to register the product; "pharmaceutical form" means the form stating- (a) the presentation of a product including solution, suspension, eye drops, emulsion, ointment, suppository, tablet, capsule; (b) in case of injections, the type of presentation including vial and ampoule; and (c) the dental cartridge and the type of content including powder for reconstitution, solution, suspension, oily solution; "pharmaceutical product" means any medicine intended for human use and a veterinary product administered to food-producing animals, presented in its finished dosage form or as a starting material for use in the dosage form; "primary batch" means a batch of an active pharmaceutical ingredient or finished pharmaceutical product used in a stability study, from which stability data is submitted in an application for registration for the purpose of establishing a re-test period or shelf-life; "product" means a drug or preparation for human or veterinary use or a vaccine or other immunological product; "production" means all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to completion of the product; "production batch" means a batch of an active pharmaceutical ingredient or finished pharmaceutical product, manufactured at production scale by using production equipment in a production facility as specified in the application; "proprietary name" means the trade or brand name which is unique to a particular product and by which the product is generally identified and registered in the country of manufacture; "reprocessing" means the reworking of all or part of a batch of a product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations; "shelf life" means the time during which the quality of the product remains acceptable for its intended use, established based on stability studies; "starting material" means any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials; "validation protocol" means a document describing the activities to be performed in a validation exercise; "validation report" means a document in which the records, results and evaluation of a completed validation program and proposals for the improvement of processes or equipment are assembled.