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Active Ingredient: a substance or bulk pharmaceutical chemical that is intended to furnish 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 man or other animals.
Adulterated Substance: a material that has either been contaminated with a foreign substance or not manufactured using good manufacturing practices. This definition does not pertain to materials that do not meet physical or chemical specifications.
Aseptic: an environment free from pathogenic microorganisms.
Batch (Lot): a defined quantity of raw material, intermediate material, packaging components, or final product processed so that it is expected to be homogeneous. In a continuous process, a batch corresponds to a defined portion of the production, based on time or quantity (e.g., vessel volume, one day's production, etc.).
Batch Number (Lot Number): a distinctive combination of numbers or letters from which the complete history of the manufacture, processing, packing, coding, and distribution of a batch can be determined.
Batch Numbering System: a standard operating procedure (SOP) describing the details of assigning batch numbers.
Batch Record: documentation that provides the history of a batch from the raw material stage to completion of the batch or lot.
Blending (Mixing): intermingling different conforming grades into a homogeneous lot.
Certificate of Analysis: a document relating specifically to the results of testing a representative sample drawn from the material to be delivered.
Clean Area: an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants in the area.
Commingling: the blending of trace carryover material from one grade of an excipient with another, usually due to a continuous process.
Contaminant: an impurity not intended to be present in an excipient, which may be introduced by poor cleaning, processing, or lack of appropriate environmental and personnel controls during the manufacturing process.
Continuous Process: a manufacturing process that continually produces an excipient from a continuous supply of raw materials.
Critical Process: a manufacturing process step that may cause variation in quality attributes.
Cross-contamination: contamination during production of a raw material, intermediate, or of a finished excipient with another raw material, intermediate, or product.
DMF: detailed information submitted to the United States Food and Drug Administration concerning a specific facility, process, or product intended for incorporation by reference into a new drug application, supplemental new drug application, abbreviated new drug application, or investigational new drug application.
Excipient: any substances, other than the active drug or product, that have been appropriately evaluated for safety and are included in a drug delivery system to either aid the processing of the drug delivery system during its manufacture, protect, support or enhance stability, bioavailability, or patient acceptability, assist in product identification, or enhance any other attribute of the overall safety and effectiveness of the drug delivery system during storage or use.
Expiration Date: the date beyond which the product may no longer conform to relevant specifications.
Finished Dosage Form (Drug Product): a finished pharmaceutical product, prepared for consumer applications, containing excipients and the active drug substance.
Finished Product: any pharmaceutical product that has undergone all stages of production, including packaging and labeling.
Finished Process Materials: any material that has undergone all stages of production and is released from quality control.
Homogeneous Material: throughout the batch, material of uniform consistency and composition.
Impurity: a substance contained in a product other than the desired substance.
In-Process Testing: monitoring checks performed during production to ensure that the product conforms to its specifications.
In-Process Material: any material that must undergo further manufacture before it becomes a bulk product.
Intermediate Product: any material that must undergo further manufacturing steps before it becomes a bulk product.
Lot: See Batch.
Manufacturer: the company that performs the final production steps and release of the product.
Manufacturing Process: all steps necessary to produce a finished product from raw materials.
Master Formula (Master Formula Record): documentation describing the manufacture of the excipient from raw material to completion of the lot or batch.
Material Review Board: a committee or group selected to evaluate the disposition of potentially nonconforming material.
Model Product: a product that simulates a group of like products.
Mother Liquor: a concentrated solution from which the product is obtained by evaporation, freezing, or crystallization.
Re-evaluation Date: that date beyond which the bulk pharmaceutical excipient should not be used without prior adequate re-examination.
Representative Sample: a sample drawn according to an appropriate sampling plan, which may involve regular or random selection.
Reprocessing: introducing back into the process previously processed material that did not conform to standards or specifications and repeating steps that are already part of the normal manufacturing process.
Nonconforming Material: any material that does not meet manufacturer's specifications or applicable good manufacturing practices.
Packaging: the act of filling and labeling a container with a product.
Packaging Material: the containers, closures, and labels employed in the packaging of a product.
Processing Instructions: the manufacturing procedures set forth in the master formula.
Production: all operations involved in the preparation of an excipient pharmaceutical product, from receipt of raw materials through the completion of a finished product.
Purification: the process of removing impurities from a substance.
Quality: the totality of features and characteristics of a product that bear on its ability to satisfy stated or implied needs.
Quality Assurance: all those planned and systematic actions necessary to provide confidence that a product or a service will satisfy given requirements for quality.
Quality Control: all activities such as measuring, examining, testing, or gauging one or more characteristics of a product (including raw materials) and comparing the findings with specified requirements to determine conformity.
Quality Control Instruments: measurement instruments used to monitor the manufacturing process, in-process controls, and the finished excipient products for final quality control approval.
Quarantine: the status of any material isolated physically or by other effective means while awaiting a decision on its use.
Raw Material: any substance used in the production of a product excluding packaging materials.
Reserve (Retained) Sample: a representative sample of the final excipient batch of sufficient quality and quantity necessary to perform quality control analyses twice.
Returned Products: finished products sent back to the manufacturer.
Reworking: introducing previously processed material that did not conform to standards or specifications to processing steps that are different from the normal process.
Significant Processing Step: processing steps that are required to produce an excipient that meets the established physical and chemical criteria.
Shelf Life: the length of time during which the excipient exhibits stability.
Specifications: the quality parameters that serve as a basis for quality evaluation and to which the products or materials must conform.
Stability: the continued conformance of the excipient to its specifications.
Standard Operating Procedures (SOPs): a written authorized procedure that gives instructions for performing operations.
Validation: documentation that states that any procedure, process, equipment, material, or activity consistently leads to the expected results.
Vendor: an organization contracted to supply a material or perform a service.