Customs - Trade Partnership Against Terrorism
Corrective and Preventative Actions
Chemical Abstracts Service Registry Number
The European Chemical Industry Council
Certificate of Suitability to the European Pharmacopoeia
A legal document that certifies the quality of the excipient and demonstrates that the batch conforms to the defined specifications, has been manufactured under excipient GMP, and is suitable for use in pharmaceuticals. [1] [16]
Certificate granted by the European Directorate for the Quality of Medicines (EDQM) to manufacturers of active ingredients or excipients confirming that the applicable Ph Eur monographs and general chapters are adequate to control the chemical purity of the material. Also, a CEP can also be granted to confirm a material conforms to the Ph. Eur. general chapter 5.2.8 ‘Minimizing the risk of transmitting animal spongiform encephalopathy agents via medicinal products', even if the material itself does not have a Ph. Eur. monograph.
Chemical Facility Anti-Terrorism Standards
Current Good Manufacturing Practice
A process used for management review of proposed changes that may impact the quality or regulatory conformance of the excipient. [1]
Chines Pharmacopoeia
Chemistry, Manufacturing and Controls
Contract Manufacturing Organization
A co-processed excipient is a combination of two or more compendial or non-compendial excipients designed to physically modify their properties in a manner not achievable by simple physical mixing, and without significant chemical change. However, in some instances, formation of necessary components may occur, such as in situ salt formation.
The act of manufacturing a co-processed excipient. Several methods may be used, including standard unit operations such as granulation, spray drying, melt extrusion, milling, etc.
Certificate of Analysis
Certificate of Conformity
A systematic approach to the start-up and turnover of facilities, systems, and equipment to end-users and ensuring that user requirements and design specifications are met (International Society of Pharmaceutical Engineering [ISPE], 2007). Activities within this phase may include design reviews, factory acceptance testing, installation verification, and functional testing. Summary reports are generated at the conclusion of commissioning activities and include an overview of the results and any deviations encountered during testing. [18]
Any material present in the excipient that arises as a consequence of the raw materials and/or manufacturing process. [1]
A description of all of the components present in the excipient.
A substance found in an excipient that is not the nominal chemical entity, may be necessary for assuring the proper performance of the excipient in its intended use, and is not undesirable, an impurity or a foreign substance. Sometimes referred to as minor component.
The undesired introduction of impurities of a chemical or microbiological nature or foreign matter into or onto a raw material, intermediate or excipient during production, sampling, packaging or repackaging, storage or transport.
A process that continually produces material from a continuing supply of raw material.
A planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to excipient materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.
Regulators typically consider the country of origin of an excipient to be the place in which the final chemical step was completed. [EIP]
Process Capability Index
Critical Process Parameter
Critical Quality Attribute
An excipient physical, chemical, or microbiological attribute (defined by an excipient User), not necessarily reflected in supplier specifications or monographs that must be within appropriate limits, ranges, or distributions, to ensure that critical quality attributes (CQAs) for a particular drug product are maintained throughout the product life cycle.
A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. [9]
A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. [2] [23]
Contamination of a material or product with another material or product. [EIP] [1] [8] [13] [15]
Common Technical Document
