Supporting Compliance in Controlled Markets
Manufacturers operating in pharmaceutical, vaccine, medical device or other controlled markets must comply with strict regulatory requirements. Any significant changes to raw materials, equipment or processes can impact product quality and performance, making timely product change notification essential.
Avantor® provides product change notifications across our portfolio to help you maintain compliance and ensure business continuity. Our programs are tailored to the specific needs of each market and are aligned with global regulatory guidelines.
Avantor® performance materials: Proprietary chemicals
Our proprietary chemical portfolio (J.T.Baker® and Macron Fine Chemicals™) is supported by a five-tiered Management of Change (MOC) program. Each product is classified to indicate the level of notification support customers will receive.
- Five-tier classification system - From highly regulated (cGMP grade) to nonregulated materials.
- Customer notifications - For regulated materials, Avantor customers of record (purchases in the past 36 months) automatically receive notifications of significant changes. Nonregulated materials will not have notifications issued.
- Optional registration - Customers can opt in to receive notifications even if they haven’t purchased recently.
- Global support - Our change notification experts provide a single point of contact and access to supporting documentation.
Contact: [email protected]
Avantor® fluid handling: Proprietary single-use solutions
For biomanufacturing workflows, the Avantor Fluid Handling (AFH) program ensures transparency when changes occur in our single-use solutions portfolio.
- Automatic notifications - AFH program customers of record (purchases in the past 36 months) are notified of critical changes.
- Quality assessment - Changes are evaluated against BioPhorum Operations Group (BPOG) criteria.
- Comprehensive tracking - All changes are managed in Avantor’s electronic Quality Management System (EtQ).
- Masterflex® products - Change notifications for Masterflex products are assessed by the AFH team and communicated through the VWR® Change Notification Service (CNS). End users must be enrolled in the VWR CNS to receive notifications for Masterflex products.
Contact: [email protected]
| MOC Category | HR Highly Regulated | R Regulated | RL Regulated Limited | NI NonRegulated, With Information | N NonRegulated |
|---|---|---|---|---|---|
| Bulk pharmaceutical | Yes | Yes | Yes | No | No |
| Intended/Potential use | API, BPE | BPE | Processing aids, food | Reagents | Reagents |
| Grades | USP, NF, EP, BP, JP, ChP | USP, NF, EP, BP, JP, ChP | IP, EP, FCC | ACS, reagents | ACS, reagents |
| Notification of change | Yes, Level 2 | Yes, Level 2 | Yes, Level 2 | Limited if registered in MOC database | None |
| Industry reference | IPEC, Q7 | IPEC, Q7 | FCC, IP, EU | None | None |
| Regulating body | FDA, cGMP | FDA, cGMP | IFDA, EU, food GMP | None | None |
VWR® Change Notification Service (CNS): Distribution products
For products sourced from third-party suppliers, Avantor offers the VWR CNS. This free, opt-in service facilitates communication between suppliers and customers in controlled markets.
How it works:
- Customers, with their Avantor representative, identify critical products to enroll.
- Avantor negotiates a Change Notification Agreement with the supplier.
- Once confirmed, enrolled customers receive notifications directly when a supplier issues a change.
- Avantor provides full traceability, supporting documents and customer-specific material references.
Key features:
- Free service with no minimum order requirement.
- Flexible enrollment by product, site or internal material number.
- Validated software platform with audit trail and reporting tools.
- Centralized global support and assistance with supplier communications.
Contact: [email protected]
NuSil® Change Notification policy
For more information on NuSil® Change Notification policy, please contact us at [email protected].