Production quality

The confidence of patients is based on the high quality standards we set ourselves in the production of safe and effective medicines. All Johnson & Johnson companies are evolving towards one policy with regard to quality requirements and compliance with all procedures and directives in order to be able to guarantee quality products.
The following requirements are thereby adopted:
- all products must meet the procedurally defined safety and quality requirements, and must retain their effectiveness during their entire life cycle;
- all products and ingredients we purchase from external suppliers must always meet our requirements;
- any adjustments to the ingredients, labeling or packaging of our products, to the processes, systems, methods and equipment must always be critically assessed and approved before the adjustments may be implemented;
- procedures must be in existence to prevent our products being diverted to a distribution channel other than the one scheduled, and to protect them from being counterfeited.
Janssen works closely together with the authorities and agencies that impose the standards, as well as with professional organizations to ensure that our quality systems are up-to-date and are constantly being improved.


The Janssen production factories are ISO certified, which means that the quality assurance system has been thoroughly examined by means of an external audit and meets the strict, predetermined standards. They also consistently apply Good Manufacturing Practices. The Janssen Diagnostics Software device is ISO certified, and the Janssen Diagnostics laboratory is CAP/CLIA (College of American Pathologists / Clinical Laboratory Improvement Amendments) accredited, with both meeting the GCLP (Good Clinical Laboratory Practice) requirements.
Training courses provide the staff with the necessary means to set up and manage quality assurance systems, in order to ensure that the delivered medicines have the intended effectiveness and meet all the legal provisions.
Janssen was subjected to 32 inspections (governments, customers, internal audits) in 2012, and the results of these audits were always very positive.
Quality and confidence are also related to the continuity of our operations, even in the event of a crisis. The business continuity policy is designed to assure the continuity of our operations.
Audits: strict regulations and controls
Few industries are subject to such strict controls by internal and external bodies as the pharmaceutical industry. Janssen is also regularly visited by external teams, who scrutinize our processes down to the smallest detail. An audit can focus on one specific product or process, or concentrate on the whole organization and all products. A total of 27 audits were carried out in 2013.
As far as the sales of Janssen pharmaceutical products is concerned, the American market is still the most important. Therefore, a successful inspection by the American Food and Drug Administration (FDA) is also extremely important. This governmental institution imposes strict world-wide standards for pharmaceutical and food products that are brought to market in the United States as well as monitoring adherence to all relevant laws and regulations. In 2013, Janssen was once again paid several visits by the FDA.
But the Belgian authorities also regularly send around an inspection team that comes and performs inspections on behalf of the European Medicines Agency (EMA). In addition to all of this, upcoming markets, such as Brazil, South Korea and Turkey more and more often carry out controls on medicines that are destined for sale within their borders.
Every year Janssen is also subject to 10 to 15 audits from customers, because they too have the right to perform inspections. While the authorities' inspections can take between one and two weeks, the period for customer audits is limited to one or two days. Janssen allowed the external organization APIC to perform its own inspection, which it did on behalf of a number of customers. When a customer makes a new request for a customer audit, the customer can either participate in this APIC program or can come and perform an audit itself.
Internal audits by Johnson & Johnson also keep everyone on their toes. An internal audit is prepared in exactly the same way as an external inspection. These internal audits can also expose points for improvement which must be addressed by the next external audit.

EHS&S by design tool for supply chain:
Proactive design prevention
The concept EHS&S by design tool for supply chain consists of the identification of all of the possible legal obligations and sector-related safety and health risks in the early stages of a project. This process must ensure that the legal regulations and risks are sufficiently and adequately applied to and factored into the design, construction and start-up of a building, installation or machine.

The process was started on the Janssen Campus, and in 2013 was implemented world-wide within the global Johnson & Johnson (J&J) Supply Chain. Environment, health, safety and sustainability are the key words for this proactive design prevention implemented by a cross-functional team. It is one of the best ways to prevent occupational accidents and incidents.
When the principles of environment, health, safety and sustainability (EHS&S) are not integrated soon enough into the design/procurement of an installation, potentially hazardous consequences may result—hazardous situations and potential accidents, unforeseen adaptation costs in the start-up phase, a failure in the approval phase of a process or the selection of incompetent suppliers.
Managing the EHS&S risks in a standardized, structured and documented manner, on the other hand, helps to eliminate blind spots, to support prevention, to comply with regulations and laws and to eliminate unsafe conditions. In addition to the tool for critically accessing a project, an ancillary process which ensures the training of the employees must also be developed.
Over a period of two years, this process and the tools were rolled out across the various technology platforms within the Janssen Supply Chain. The development of the process and the tools occurred in 2009-2010 followed by the general implementation at the Janssen Supply Chain sites in 2011-2012.
During the projects, EHS&S provides a standardized integration of the local, national and Johnson & Johnson guidelines in the areas of environment, health and safety. Economically speaking, costs are saved each year as a result of the timely exclusion of non-regulation projects. The portion of the equipment costs amounts to 4% of J&J's annual equipment budget (4 to 6 million USD per year).
Business continuity management
Business Continuity Management (BCM) aims to assure the continuity of the business operation and the survival of the organization in the event of a crisis. An efficient and effective BCM policy acts as a guideline for normalizing the business operation as quickly as possible, while at the same time reducing the impact on reputation and capital structure.
The BCM policy is established at the Johnson & Johnson (J&J) level, and was implemented at the Belgian campus in 2003. BCM has therefore been a priority at Janssen for 10 years, and is an important component of our DNA, of who we are and how we operate. The BCM process provides concrete crisis management in the event a crisis occurs.
Since 2013, a J&J-developed risk analysis method has also been implemented at the Janssen Campus. This method is a proactive manner to identify risks so that Janssen can adequately respond to all seriously disruptive occurrences. J&J uses this method to make the greatest risks visible and to provide measures to prevent or reduce these risks.


All activities, efforts and facilities relating to the organization's preparation for a crisis, such as a natural disaster or an external electricity blackout, are covered by the crisis management policy.
The prevention of a crisis is, of course, the central focus in our daily practice. Should a crisis still occur, the intention is to manage it as soon as possible, and to minimize any consequences. In such a situation, routines, habits and standard procedures are no longer useful, and a strategic, effective and efficient organization is required that is ready to assure the continuity of the organization .
The crisis management team regularly carries out internal ‘Command Post Exercises’. The team is then presented with a customized crisis scenario. The exercise consists of the application of the necessary steps of the Business Continuity Plan in order to control the crisis.
By going through this BCM process, we systematically improve our ability to protect and support patients, staff and customers, no matter what happens.