The accelerated stability studies are designed to increase the rate of chemical degradation or physical change of a Drug Substance (DS) / Active Pharmaceutical Ingredient (API) or Drug Product (DP) using exaggerated storage conditions. The purpose of the study is to monitor any degradation reactions which than will help to predict the shelf life of a Drug Substance (API) or Drug Product (DP) under the defined (ICH) storage conditions.
The acceptance criteria are pre-defined and agreed standards, limits or ranges between different parties such as Quality Assurance and Quality Control or Manufacturing and Quality Assurance or suppliers
The specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan that are necessary for making a decision to accept or reject a lot or batch of raw material, intermediate, packaging material, or active pharmaceutical ingredient. This term can also be applied to validation.
Means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)). All definitions in section 201 of the act shall apply to these regulations.
The action level is a pre-defined and between different parties agreed written level. Once these levels are exceeded, actions must be undertaken. A complete investigation must be carried out and documented accordingly.
Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to effect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect
An API also called Drug Substance (DS) is any physiologically active substance that is intended for use in a Drug Product. An API is also a substance when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished Dosage Form of the Drug.
Any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug. 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 of humans or other animals. APIs include substances manufactured by processes such as chemical synthesis; fermentation; recombinant DNA or other biotechnology methods; isolation/recovery from natural sources; or any combination of these processes.
The quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular API or intermediate.
Adulterated Product is a Product or Medical Devices when it contains any filthy, putrid or decomposed Substance. This also applies for a Product or Medical Devices when it was prepared under unsanitary conditions or was not made in accordance with the GMPs. This could be also a Product or Medical Devices which contains an unsafe colour additive, or does not meet the requirements of an official compendium or Product registration.
Any adverse event associated with the use of a drug in humans, whether or not considered drug related.
An airlock is called a room or space with two or more doors that is interposed between two or more rooms. This is usually build in between different class of cleanliness, for the purpose of controlling the air flow and pressure differential between those rooms. An airlock is designed for personnel or goods.