Merck產品相關資訊
| 瞭解不同MQ level下的產品具體屬性 | ||||||
| Quality Segments | ||||||
| MQ100 | MQ200 | MQ300 | MQ400 | MQ500 | MQ600 | |
| Application scope | For non-regulated applications with no change notification requirements | For non-regulated applications with limited change control requirements | For products used in applications requiring enhanced change control and quality agreement | For critical products and applications driven by high expectations and requiring verified process control or manufacturing control | For regulated applications | For highly-regulated applications under authority surveillance |
| Discriminating features | Standard control | Increased control | Enhanced control | Driven by customer expectation | Driven by authority regulations | Driven by authority regulations and surveillance |
| Quality systems | ISO 9001 | ISO 9001, ACS | ISO 9001, ACS | ISO 9001 and/or ISO 13485 and other controled processes |
ISO 9001, and/or applicable standards IPEC GMP, HACCP FSSC 2200 | ISO 13485 and/or ICH-Q7, 21CFR, cGMP |
| Quality attributes (e.g. specifications, Certificate of Quality) | V | V | V | V | V | V |
| Basic change control | V | V | V | V | V | |
| Enhanced level of control | V | V | V | V | ||
| Verified process | V | V | V | |||
| Certified/validated process | V | V | ||||
| Highly regulated application | V | |||||
| 不同 MQ level 的品質屬性對比 | |||||||
| 不同 MQ level 的品質屬性對比 | Description | MQ 100 | MQ 200 | MQ 300 | MQ 400 | MQ 500 | MQ 600 |
| Quality Standard | ISO 9001 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| IPEC GMP or HACCP or FSSC 22000 ISO 13485 (Different classes) |
✓ | ✓ | |||||
| ICH Q7 | ✓ | ✓ | |||||
| Specifications available | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Certificate of Quality or Certificate of Analysis available | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Release testing - performed using established protocol | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Written SOP for process control | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Supplier approval process in line with corporate quality programs | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Change notification available as an opt-in for individual products. Notifiable events differ between MQ levels. | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Release testing - performed using established or published protocol | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Site quality self-assessment available | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Shelf Life/Expiration date is identified if applicable | ✓ | ✓ | ✓ | ✓ | |||
| Physical audits can be requested by customer | ✓ | ✓ | ✓ | ✓ | |||
| Product can be added to a Quality Agreement | ✓ | ✓ | ✓ | ✓ | |||
| Analytical method is verified | ✓ | ✓ | ✓ | ||||
| Analytical method may be shared upon request | ✓ | ✓ | ✓ | ||||
| Quality declarations as required by regulation or product application | ✓ | ✓ | ✓ | ||||
| Process control is verified | ✓ | ✓ | ✓ | ||||
| Supplier approval by paper audit or questionnaire | ✓ | ✓ | ✓ | ||||
| Original manufacturer disclosure may be requested with signed confidentiality commitment | ✓ | ✓ | ✓ | ||||
| Controls for subcontracting are established | ✓ | ✓ | ✓ | ||||
| Primary packaging component control | ✓ | ✓ | ✓ | ||||
| Original manufacturer disclosure available with signed confidentiality commitment | ✓ | ✓ | |||||
| Analytical method is validated | ✓ | ✓ | |||||
| Process control is validated | ✓ | ✓ | |||||
| Supplier approval by on-site audit for critical suppliers | ✓ | ✓ | |||||
| Shelf life/Expiration Date is defined by stability study | ✓ | ✓ | |||||
| Original manufacturer disclosure available without confidentiality commitment |
✓ | ✓ | |||||
| Risk Based approach to controlled conditions for warehouse & shipping | ✓ | ✓ |