Change of our Immediate Supplier - no disclosure of source
Change to primary manufacturing and/or Repackaging/Downfilling site
Change in test method (non-compendial and those affecting quality document (CofA/CofQ) or label)
Changes in the Manufacturing Process impacting specification, where process uses a substantially different route of Synthesis or manufacture (Chemicals)
Primary Packaging Materials and/or Container Closure Change in Materials of Construction (not including customized packaging)
Change to Raw Materials affecting the CoA or CoQ or Specification
Labeling - Change to item name or number
Changes in the labeling regarding product name, specification, shelf-life or storage
Change in the nature of the raw materials with TSE/BSE relevance resulting in an increased risk for the finished product with respect to EMA/410
Changes in the Manufacturing Process impacting specification, or intended use, form/fit/function (Disposable/Devices/Single Use items only)
Change of Original Manufacturer (OM) - disclosure of OM not guaranteed (Confidentiality Commitment required in case of disclosure)
Changes to the Equipment - impacting the manufacturing process, specifications or intended use
Change in GMP Status
Change of Original Manufacturer (OM) - disclosure with Confidentiality Commitment
Changes to Instructions for use and change in Risk level
Change of Original Manufacturer (OM) - disclosure w/o Confidentiality Commitment
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.
|Food and Drug Administration (FDA)||United States Food and Drug Administration 21CFR820.50 "Title 21-Food and Drug Administration Department of Health and Human Services, Sub chapter H Medical Devices"|
|European Commission (EC)||EU Guidelines for Good Manufacturing Practice of Medicinal Products, In vitro Diagnostic Medical Device Regulation (IVDR)|
|United States Pharmacopia (USP)||USP <1195> "Significant Change Guide for Bulk Pharmaceutical Excipients" Adopted IPEC 2009 Guidelines|
|International Pharmaceutical Excipient Conference (IPEC)||"Significant Change Guide for Pharmaceutical Excipients" Third Revision 2014 IPEC & PQG Joint Good Manufacturing Guide for Pharmaceutical Excipients|
|BioPhorum Operations Group (BPOG)||White Paper: An Industry Proposal for Change Notification for Single-use Biomanufacturing Systems|
|Rx360 An International Pharmaceutical Supply Chain Consortium||Rx-360 Best Practice Guide on Quality Agreements|
|International Organization for Standardization ISO||ISO 22000 Food Safety Management, ISO Standards for the Microbiology of Food, Beverages and Animal Feedings|
|International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use (ICH)||Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7|
|EXCiPACT||Certification Standards for Pharmaceutical Excipient Suppliers: GMP, GDP|
Quality Management Systems
At the core of maintaining our high quality and regulatory standards is a robust Quality Management System, where all relevant quality and regulatory processes are described. Inspections from authorities, customer and internal audits, customer feedback, along with targeted quality improvement plans provide the input for maintaining these highest standards, as well as for continuously improving our systems, processes and products. This results in an active involvement and ownership of employees across all functions and lives the model that Quality is embedded in everything we do.
The Quality Management Systems & Audit team works to assess, govern and implement quality processes across our materials business with the aim of continuously improving our systems and performance.
The team is responsible for:
● Continuously gathering information from the experiences of customers using our products
● Routinely monitoring and reporting these experiences to all levels of management
● Providing a management system for resolving customer issues or complaints
● Taking corrective actions when necessary
● Examining the customer's information to identify, delineate and report trends
● Ensuring continuous improvement through self-assessment
Customer Support – Quality Services
Every manufacturer must ensure their suppliers provide products that are fit for purpose throughout the product lifecycle, from design and development through to supply to the end-user.
Our Quality Services team is responsible for quality-related elements of Customer Inquiries and Customer Communication. We partner with our Technical and Customer Services teams to ensure a seamless support network. In addition, we push industry standards forward and add value to our customers by providing superior quality and regulatory services.
Regulatory Focus Areas
The materials industry operates in one of the world's most regulated environments. Today, we are facing increasing regulatory requirements and complexity.
As a global leader in the materials industry, we are on top of current trends and future quality and regulatory opportunities as well as challenges. We support our customers to navigate and comply with a highly complex set of global, regional, country, and industry-specific directives and regulations.
● Pharmaceutical Industry
● Biopharma Industry
● Cell & Gene Therapies
● Food Industry
● Medical Devices/In Vitro Diagnostics
● Regulatory Support
Our regulatory expert teams support a high-performance supply chain to ensure delivery of Life Science products on time, every day.
● Trade Compliance
● Hazard Communication & Chemical Regulations