Merck

Change Notification Program

Our Life Science business sector serves customers across academia, the biopharmaceutical industry, and the industrial sector, including food & beverage, with a broad portfolio of more than 300,000 products and solutions. To ensure that we provide the most-up-to-date product information, we have a best-in-class Change Notification Program based on a validated Change Control process and on our M-Clarity™ Program to inform customers about important changes that could impact their R&D or process development programs.

Customer benefits from our Change Notification Program:

  • You choose the product according to the appropriate MQ level for your application
  • The amount of information given in the Change Notification is transparent with respect to the quality level of the product
  • No more, no less of the information that is required: extensive delineations where necessary, short summary, where sufficient
  • Customers define their Change Notification requirements: products on which they would like to receive notifications, persons to be informed, required e-mail or post addresses
  • Standardized, easily understandable Change Notification letters and follow-up documentation

State-of-the-art Management of Changes

The process of managing change is complex and includes many deliverables which may occur concurrently or consecutively. Change Control Management is Project Management, and the key requirement is to define tasks, allocate roles and responsibilities and follow-up on tasks in a timely and complete manner. To facilitate Change Control Management and make potential risks, decisions, deliverables, and results transparent, our company uses one of the world's leading Quality Management software systems, TrackWise®, for Change Control. This validated system enables us to initiate, plan, execute, monitor, and control critical processes to guarantee product quality for the benefit of our customers.

We record all changes using TrackWise® QMS software, and from those changes we determine if a change notification is required based on the quality level of the product, industry expectations, existing agreements, and the risk assessment associated with the change and its potential impact on the final product and recommended application.

Throughout the Change Notification process, from selecting changes and customers to notify to sending out Change Notification letters, we follow the guidelines from Regulating Authorities and Trade Associations.

Notifiable Changes

Our customers have the option to be informed about relevant changes that might affect the performance of our product and subsequently impact the customer’s processes or products. Change Notifications on one hand, must contain all necessary information, while on the other hand, must be relevant to our customers. Our M-Clarity™ program ensures we keep this balance and customers get exactly the amount of information needed for the intended use of the product.

The M-Clarity™ Program defines six product quality levels from MQ100 to MQ600 and appropriate quality attributes and notifiable changes provided for each level. According to our M-Clarity™ program, products with different MQ levels get a different extent of change notification.

The Matrix of Notifiable Changes below gives an overview of which information is provided to our customers at each MQ level.

The Matrix of Notifiable Changes is not intended to be all-inclusive. A Change Team can determine whether a change is notifiable outside of the tables based upon a detailed risk assessment and the recommended use of the product. All Change types relate exclusively to the finished product.

The Notifiable Change Table offers detailed explanations of the notifiable events at each MQ level.

Change Notification Letters

In the event of a change, customers who have entered or “opted-in” to our Change Notification program via a Change Notification Commitment (CNC) or Quality Assurance Agreement (QAA) will be informed via a Change Notification letter driven by the Matrix of Notifiable Changes.

To present the information in the clearest way possible, we use standardized templates for notifications, making it easy to find the details that are most relevant for a customer, regardless of product or manufacturing site.

Our Change Notification letters are individualized to include only the products where we have a customer agreement in place. This eliminates the need to perform comparisons of impacted products to identify those products purchased by our customers.

Our Change Notifications are clear and concise, and set the industry standard. We have developed comprehensive Change Notification letters based on our experience of managing a broad product portfolio, with continuous improvement built-in, based on customer feedback and industry expectations.

How to Receive Change Letters

Change Notification Commitments (CNCs)

The easiest and quickest method to obtain an agreement for Change Notification is to request a product specific agreement via the CNC process. By building our Change Notification program on this opt-in process, we prevent our customers from receiving non-relevant letters as they might trigger unnecessary resource intensive investigations. You can enroll all products deemed critical, despite order history. In setting up a CNC, you choose the products of interest (MQ200 to MQ600) for which you would like to receive Change Notifications, providing the e-mail addresses of departments or individuals to be informed of the change. We do not offer CNCs for products with quality level MQ100, services, labware or distributed products.

The term of the CNC is normally is five years. Six weeks before expiry of your CNC, you will receive an expiration notice. With this reminder, you can establish a new CNC to grant continuous Change Notification as necessary or decide against a prolongation. This will prevent receiving change notifications that are no longer relevant.

Quality Agreements (QAAs)

Quality Assurance Agreements are legally binding contracts negotiated between our company and our customers. Having executed a QAA for products used in regulated environments, you can be sure to comply with applicable regulatory and legal requirements.

QAAs address and define various topics related to the quality standards/systems/ services applicable to the covered products: Quality Management System standards/certifications (i.e., pharmaceutical GMP, ICH Q7, IPEC PGQ GMP, ISO-9001, ISO-13485, ISO-22000), complaint handling, audits, recalls, documentation support, level of verification/validation, and notification of changes. Due to the extended requirements and support levels that need to be in place, QAAs are available for products with MQ levels of MQ300 and above.

The term of a QAA is five years. An expiry notice will be received two months in advance, to allow time to prepare for a renewal.

When the QAA is finalized and fully signed, the information is secured in our dedicated IT system and Change Notifications will be received for the products covered by the QAA in accordance with the M-Clarity™ program.

If you are interested in a QAA or a CNC for critical raw materials, please contact your local representative.

Change Notification Glossary