In the context of excipient manufacturing, a general term used to denote materials, reagents and solvents intended for use in the production of intermediates or excipients. [1]
The date beyond which the excipient should not be used without further appropriate re-examination to ensure that it is still in conformance with the specification. [1]
Registration, Evaluation, Authorisation and Restriction of Chemicals
A process for withdrawing or removing product from the distribution chain because of defects in the materials or complaints of a serious nature. The recall might be initiated by the manufacturer/importer/distributor or a responsible agency. Note: In the USA, the term recall has specific regulatory implications that do not directly apply to excipients. Therefore, the term retrieval is typically used in the USA. In this document “recall” has the same meaning as retrieval. [1]
Process of putting a new label on the excipient. Traceability to the original manufacturer is only assured if the relabeler provides access to its quality systems. [EIP] [16]
An expression of the degree to which a measurement performed by different people at different times and under different circumstances produces the same results (see also validity). [19]
The action of changing the packaging of the material. [EIP, CoA] [2] [16]
Manufacturing equipment that uses the same operating principle and is of similar construction or packaging components made with the same materials of construction and sealed in a similar manner.
Repetition of an activity that is a normal part of the manufacturing process and that has been documented previously. [13]
Residual solvents are defined as organic chemicals that are used or produced in the manufacture of active substances or excipients, or in the preparation of medicinal products. ICH Q3C Impurities: Residual Solvents. [EIP, Composition] [5]
A voluntary program to achieve improvements in environmental, health and safety performance. Adopted by most Chemical Industry associations worldwide. [34]
Representative sample of a batch/delivery that is sufficient quantity to perform at least 2 full quality control analyses and will be kept for a defined period of time.
(refer to Re-evaluation Date) Note: In the USA, the term recall has specific regulatory implications that do not directly apply to excipients. Therefore, the term retrieval is typically used in the USA. In this document “recall” has the same meaning as retrieval. [1] [3] [8] [15] [16]
The period of time during which the excipient is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the excipient has been stored under the defined conditions. After this period, a batch of excipient destined for use in the manufacture of a drug product should be re-tested for compliance with the specification and then used immediately. A batch of excipient can be re-tested multiple times and a different portion of the batch used after each re-test, as long as it continues to comply with the specification. [3]
Subjecting previously processed material that did not conform to standards or specifications to processing steps that differ from the normal process. [1] [13]
The decision to accept risk (ISO Guide 73). [Risk Assessment Part 1] [6] [10]
The estimation of the risk associated with the identified hazards. [Risk Assessment Part 1] [2] [6] [10] [23]
A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. [Significant Change, IE Risk Assessment] [1] [2] [6] [10] [23]
The sharing of information about risk and risk management between the decision maker and other stakeholders. [Risk Assessment Part 1] [10]
Actions implementing risk management decisions. [10]
The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk. [Risk Assessment Part 1] [10] [23]
The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description. [6] [10] [23]
The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk. [6] [10]
Actions taken to lessen the probability of occurrence of harm and the severity of that harm. [Risk Assessment Part 1] [10]
Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk. [10] [23]
Risk Priority Number
An International Pharmaceutical Supply Chain Consortium
