Current good manufacturing practice (CGMP): These are the basis principles, procedures and resources required to ensure an environment suitable for manufacturing products of an acceptable quality.
Contract manufacturing organization (CMO): A company offering manufacturing services with capacities ranging from small volumes for pre-clinical processes to larger volume for full-scale commercial manufacturing.
Active pharmaceutical ingredient (API): These are either substances or a mixture of substances used in the manufacture of a drug product, which becomes an active ingredient of the drug. APIs are intended to cause pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of diseases or to affect the structure and function of the body.
Dosage form: Refers to the form in which the drug is delivered to the patient. Dosage forms include parenteral, topical, tablet, oral (liquid or dissolved powder), suppository, inhalation, and transdermal.
Fill and finish: These are secondary elements of the drug manufacturing process, which includes formulation, vial preparation, filling, capping, and inspection.
Generic drug: Drug product sold under a branded drug’s chemical name, following the expiration of the pertinent patents to the branded drug. Drug patents are issued for up to 20 years from time of filing. The active ingredients in the branded and generic products are the same. Both the branded and the generic versions must have the same potency, be available in the same dosage forms (i.e. tablet, liquid, injectable), be demonstrated safe and effective, and be manufactured under government-approved GMPs.
Lyophilization: Also known as freeze drying, lyophilization is a means of stabilizing wet substances by freezing them, then evaporating the resulting ice, to leave a substantially dry, porous residue which has the same size and shape of the original frozen mass
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