May 25th, 2010
McNeil Consumer Healthcare’s Plans to Assess and Address Quality Issues
To help inform employees of the Johnson & Johnson family of companies, McNeil Consumer Healthcare today released a description of its plans to assess and address quality issues which precipitated the recent recall of certain McNeil infants’ and children’s liquid medicines and the suspension of production at the Fort Washington PA manufacturing facility on April 30. Last Friday, McNeil submitted materials to the U. S. Food & Drug Administration which outlined its actions and plans to help ensure quality moving forward, and address the FDA’s observations at the plant. And this Thursday, Colleen Goggins, Worldwide Chairman, Consumer Group will represent Johnson & Johnson before the U. S. House of Representatives Oversight and Government Reform Committee, which has called a hearing on the recall. The following is the description of McNeil’s plans:
McNeil is taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies, and that the public rightly expects of us, and that we expect of ourselves.
First, even before the most recent recall was announced, McNeil retained an independent third-party expert to assist the Fort Washington facility in identifying immediate, interim, and long-term corrective actions that it needs to take. The third-party expert is a pharmaceutical consulting firm that has expertise in manufacturing and quality systems methodologies and practices.
Second, McNeil is improving processes and employee training in every part of the manufacturing and quality operations, and deploying new procedures and processes for the conduct of quality investigations.
Third, McNeil has also made significant organizational changes in order to augment the quality and operations leadership on the management team and in all McNeil facilities.
McNeil and its outside consultant are in the process of developing a comprehensive action plan on quality improvements, which McNeil will share with the FDA by July 15. The basic elements of the plan include the following:
Governance and management controls. Governance during the remediation period will include the establishment of a steering committee, which will include members of senior management, charged with guiding and overseeing remediation efforts across McNeil. Each plant will also have a remediation committee that will be responsible for implementing the plan for that plant and monitoring its effectiveness. Achieving long-term improved management control at each site is critical, and will require an evaluation and restructuring where needed of, among other things, the quality control unit, McNeil’s development and manufacturing governance processes, and its quality management systems.
Training and Culture of Compliance. McNeil is committed to reinforcing and enhancing the culture of compliance throughout the company. McNeil has already taken actions to set higher expectations of employees and to increase employee focus on identifying underlying causes and finding lasting solutions to issues that arise during daily operations. Further actions to address the culture of compliance under the comprehensive action plan will include strengthened “good manufacturing practices” training program, the development of a leadership training program and enhanced supervisor training, and the establishment of quality goals for all employees. McNeil also intends to implement measures to improve communications to and among personnel. Employees will be informed of the status of remediation and ongoing efforts on a regular basis through communications that enlist them in facilitating this transformation.
Full Assessment and Improvements. McNeil will conduct a full assessment of the processes, equipment, and facility in Fort Washington, and will assess McNeil’s other facilities as part of the plan. McNeil and Johnson & Johnson are fully committed to providing the training, resources and capital investment needed to provide sustainable improvement of quality systems.
Product Assessments. McNeil will conduct in-depth quality assessments for each product McNeil manufactures to ensure each product’s ability to meet specifications throughout its shelf life. Product assessments will review, among other things, testing results, stability data, investigation reports, out of specification findings, rejections, and process changes. McNeil will analyze whether additional controls are needed to support the release of products.
Communication with FDA and Interim Actions. McNeil will update the FDA about its progress implementing the plan at least once a month. McNeil also intends to use the support of a third party in making product release decisions during the first six months of operation. Third-party involvement may include review of investigations, complaints, completed batch records, and changes that have the potential to affect products or processes. McNeil is committed to continuing its cooperative and transparent dialogue with FDA.
These steps come on top of a series of important actions already taken, including an ongoing suspension of manufacturing operations at the Fort Washington manufacturing plant where the recalled products were made, and conducting extensive outreach to parents, caregivers and health care professionals to keep them informed about the recent recall.