Current regulatory guidance documents on data integrity emphasize drug products (DP, also known as medicinal products) and drug substances (DS, also known as active pharmaceutical ingredients, APIs). Their scope does not explicitly include or exclude excipients. However, since critical data, Good Manufacturing Practice (GMP) compliance, and confidence in the quality of the excipient is based on the integrity of data, it is important for all parties involved in the manufacture and supply of excipients (e.g. warehousing, distributing, testing and packaging) to develop and implement appropriate strategies to manage the integrity of critical data in order to provide confidence in the quality and GMP compliance of the excipient.
Many excipients are produced in facilities that manufacture products for a variety of markets (e.g., pharmaceutical, food, cosmetic and industrial). The manufacturing controls and instruments probably were:
• designed for products other than excipients
• designed and constructed with some open access components
• built with sophisticated process automation systems designed to handle highly hazardous materials
• primarily designed for manufacturing efficiency and compliance with environmental, occupational health and process safety regulations
• installed before data integrity expectations were explicitly defined.
The full report is available in the Document Depot. You must be logged in to access the Depot.