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BUSINESS CONTINUITY

SCOPE: This procedure applies to all divisions and departments in the company that are involved in maintaining business continuity. PURPOSE: This SOP describes the actions that should be taken to maintain business continuity. REASON FOR REVISION: To reflect changes in our company structure. DEFINITIONS: Business ContinuityManagement: A holistic management process that identifies potential impacts that threaten an organisation and provides a framework for building resilience and the capability for an effective response which safeguards the interests…

"BUSINESS CONTINUITY"

ANNUAL PRODUCT REVIEW

SCOPE: To offer guidance as to what information/detail should be included in an annual product review PURPOSE The purpose of this annual product review is to verify consistency of the process and to highlight any trends of the product. DEFINITIONS Annual Product Review: A review, performed at least once a year, to assess the state of quality of each product and thereby determine any needs for corrective action. This report will provide valuable information for…

"ANNUAL PRODUCT REVIEW"

History of the Orange Guide

Pharmaceutical manufacturing sites in the UK will be more than familiar with the “Orange Guide”.  This British publication has for decades contained the requirements of Good Manufacturing Practice.  This article provides a brief overview of the history of this book and also covers why it is certainly no longer a guide. First published in 1971 the original Orange Guide contained British Good Manufacturing Practice and was entitled “Guide to Good Pharmaceutical Manufacturing Practice”.  Not much more than 30 pages in…

"History of the Orange Guide"

Microbiological monitoring of pharmaceutical water systems

Water is widely used in pharmaceutical manufacturing either as a raw material, as an ingredient, or as a final product. Water is also used for rinsing equipment or for the preparation of disinfectants and detergents… These applications require pharmaceutical grade water to be used, which is water that has been through a chemical purification step. Purification is undertaken so that the water is free of substances that might cause interaction with drug substances, as well…

"Microbiological monitoring of pharmaceutical water systems"