Safety Data Sheet
Packaging materials which do not have direct contact with the excipient.
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
Any change that has the potential to alters an excipient’s physical, chemical, or microbiological property from the norm, and/or that may alter the excipient’s performance in the dosage form. [1]
A defined location of the equipment in which the excipient is manufactured. It may be within a larger facility. A change in site may be to a different part of the existing facility, but in a different operational area, or to a remote facility including a contract manufacturer.
The performance of specified tests at release on pre-selected batches and/or at predetermined intervals, rather than on a batch-to-batch basis, with the understanding that those batches not tested must still meet all the acceptance criteria established for that product. This represents a less than full schedule of testing. [16]
Periodic or intermittent testing performed for a particular test parameter, which is justified by historical data demonstrating a state of statistical process control.
Standard Operating Procedure
A list of tests, references to analytical procedures and pre-established numerical limits, ranges or other criteria for the tests described, that the material is required to meet. [1] [3] [7] [23]
An identified or unidentified impurity that is selected for inclusion in excipient product specification and is individually listed and limited in order to assure the quality of the excipient. [4] [7]
Statistical Quality Control
Any individual, group or organization that can affect, be affected by, or perceive to be affected by any action. Primary stakeholders often include excipient manufactures, distributors, users, regulators and pharmacopeial organizations. [10] [23]
A condition in which the set of controls consistently provides assurance of continued process performance and product quality. [1]
A statistical technique involving ongoing evaluation of measurements to monitor and analyze the variation in processes. [EIP]
Person or company providing excipients on request. Suppliers may be distributors or traders, etc. [1] [2] [16]
Supply chain is defined as all steps in the entire chain of distribution starting from the point at which an excipient is transferred outside the control of the original manufacturer’s material a management system downstream to the final user of the excipient. [1] [2]
Products which are not derived from starting materials sourced from plants, animals or minerals and that are not products of fermentation. Note: Also see specific regional or national organic food legislation for additional information on the use of the term synthetic.
