The consent decree formalizes the company's commitment to continuous improvement. Through its work under the consent decree, Schering-Plough is implementing Quality Management Systems and supporting processes that will allow the company to set the standard in the industry. Through this work, Schering-Plough is focusing on redesigning its manufacturing and quality management processes to be more efficient and more effective, while still assuring product quality for the patients who use the company's products. This major initiative will take time and a great deal of work to complete. The consent decree imposes significant and rigorous obligations on the company, and these are especially challenging given that the sites covered by the consent decree remain open and operating, and that all major products continue to be manufactured. Through its progress to date, the company has laid the foundation by hiring and training many new employees, installing and implementing new software systems, developing metrics for measuring results and detailing steps towards accomplishing the redesign of 23 Quality Management Systems included in its cGMP Workplan. The collaborative work, as required by the consent decree, falls into four major components: 1. Management Controls - Schering-Plough must ensure that it has the qualified personnel and management in place at each of the manufacturing sites covered by the consent decree to ensure compliance with cGMPs. As required by the consent decree, site monitors have been appointed to review all daily operations for compliance with cGMPs and to report their findings monthly to management. Action Plans to address any findings are then developed and implemented. 2. Operational Controls - The consent decree requires the review and certification of out-of-specification (OOS) and Material Review Board (MRB) investigations associated with all products manufactured at the covered sites, and a review of all variance logs by third-party expert consultants. In addition, for those products designated as medically necessary, the consent decree requires a third-party expert review of the batch production and control record, and certification prior to release. 3. Validation Certification Plan (VCP) - In general, under the terms of the consent decree, Schering-Plough has committed to having a third-party expert certify the process validation studies covering drug products and active pharmaceutical ingredients (APIs) manufactured at the sites covered by the consent decree. The objective of the VCP is to demonstrate to FDA that the company's manufacturing processes consistently produce quality products. The company is scheduled to complete its revalidation plans by Dec. 31, 2005. 4. cGMP Workplan - Schering-Plough developed a comprehensive cGMP Workplan, which received FDA concurrence in May 2003. This cGMP Workplan covers Quality Management Systems identified by Schering-Plough. It addresses immediate issues identified by FDA inspections and spells out the work to redesign 23 Quality Management Systems to ensure sustainable compliance. The cGMP Workplan also includes the execution of Parallel Elements, which involve work done in parallel with the VCP. These Parallel Elements describe such work as facility and utility upgrades, cleaning validations and packaging line qualifications. Each covered manufacturing site will undergo annual inspections by outside experts to examine, among other things, the site's progress toward full and satisfactory implementation of each element of the cGMP Workplan. |