MQ100
| Application scope | For non-regulated applications with no change notification requirements |
|---|---|
| Discriminating features | Standard control |
| Quality systems | ISO 9001 |
| Quality attributes | ✓ |
M-Clarity™ Program
The development and manufacture of products in the Life Science industry has become progressively more challenging in recent years. Because of the increasing complexity of the processes, regulatory requirements and local standards, it is crucial to understand, assess and manage risks while ensuring business continuity.
Industry-driven regulations require that products of higher criticality or those used in highly-regulated industries, such as pharma or in vitro diagnostics manufacturing, need enhanced supplier quality support.
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In this dynamic context, we present the M-Clarity™ Program which defines product Quality Segments and improves product and service transparency throughout our broad Life Science portfolio.* |
Brochure Quality Attributes Matrix of Notifiable Changes Explanation of Notifiable Changes FAQ
THE M-CLARITY™ PROGRAM GUIDES YOU TO:
The Quality Segments of the M-Clarity™ Program provide transparency so that you can choose, with confidence, suitable products that meet your needs with respect to:
- Compliance with the appropriate quality and regulatory standards
- Portfolio transparency
- Change notification service
- Documentation and support
The M-Clarity™ Program includes the majority of our products. Chemicals and Consumables are classified into 6 Quality Segments from MQ100 to MQ600, Equipment into 4 Quality Segments from EQ1 to EQ4 and Spare Parts into 2 Quality Segments SP1 and SP2.
Each Quality Segment is defined by a set of Quality Attributes and Notifiable Changes.
To learn more about the Quality Attributes and the Notifiable Changes, please click on the appropriate Quality Segment.
MQ100
MQ200
MQ300
MQ400
MQ500
MQ600
EQ1
EQ2
EQ3
EQ4
SP1
SP2
Chemicals and Consumables
| MQ100 | MQ200 | MQ300 | MQ400 | MQ500 | MQ600 |
|---|---|---|---|---|---|
| For non regulated laboratory applications, with no change notification requirements | For research, and non regulated industrial applications, with limited change notification requirements |
For products used in applications requiring enhanced change control and quality agreement | For critical products and applications driven by high expectations for manufacturing control and requiring verified | For highly regulated applications requiring a validated process control | For highly regulated applications under regulatory surveillance |
| 6 attributes | 9 attributes | 12 attributes | 21 attributes | 25 attributes | 27 attributes |
| CNC** | CNC** | CNC** | CNC** | CNC** | |
| Quality Agreement |
Quality Agreement |
Quality Agreement |
Quality Agreement |
||
| Quality Declarations |
Quality Declarations | Quality Declarations |
Equipment and Spare Parts
| EQ1 | EQ2 | EQ3 | EQ4 | SP1 | SP2 |
|---|---|---|---|---|---|
| Discriminating Attributes according to Equipment/Spare Part characteristics | |||||
| 6 attributes | 10 attributes | 12 attributes | 14 attributes | 3 attributes | 6 attributes |
| CNC** | CNC** | CNC** | |||
*Contract manufacturing products are not part of the M-Clarity™ Program.
**CNC Change Notification Commitment
For more information on the M-Clarity™ Program, please contact your local representative.