Regulators require the biopharmaceutical industry to manage changes to raw materials in a compliant way – including those initiated by suppliers. A significant challenge is how to manage the large volume of supplier change notifications (SCNs) while ensuring a compliant and uninterrupted supply of materials for production.
Companies often need to manage hundreds of raw material SCNs per year, potentially covering hundreds of materials from a complex supply chain.
However, the information provided by suppliers varies considerably (e.g. there is too little, too much, missing key details, etc.) and leads to extra communication through emails, phone calls and meetings. It is not a lean process that uses the right information in the right format.
This makes it hard for a pharmaceutical company to understand the scope of change and determine any impact on its products – this needs extra work to understand what is changing. Also, suppliers often find the process equally frustrating as they may be inundated with information requests from end-users.
The variation in content, format and level of detail highlights the need for standardization and a collaborative, consistent approach to managing supplier-initiated raw material changes sent to biopharmaceutical manufacturers.
BioPhorum’s Supplier Change Notifications (SCN): Change Areas and Requirements paper meets this need and will help industry understand raw material changes before they are implemented.
The guidance identifies eight change areas and, for each one, shows the type of changes on which industry needs to be informed. It also lists the supporting data and documentation needed to support the notification of changes.
The paper proposes that changes can be structured into eight key areas:
- Manufacturing plant or environmental conditions
- Manufacturing process, equipment and tooling
- Materials or supply base
- Inspections and tests
- Packaging, storage and labeling
- Naming and nomenclature
“The paper advocates a science and risk-based approach to controlling raw materials that is consistent with what we do in drug substance and drug product – wherever possible, streamlining and making it more efficient,” said John Cunningham, Director, Material Sciences at Janssen Pharmaceutical. “The element of standardization will benefit biopharma companies and supplier partners.”
While complete alignment and standardization on the information needed for changes are impossible, a more robust alignment on the typical information required will significantly improve the current state.
“We’re all working together to try to make the best products possible for patients and we’re trying to do that efficiently,” said Ewelina Flamm, Associate Director at Merck & Co., Inc., Kenilworth, NJ, USA. “The more we can standardize and take waste out of the system, the better.”
By highlighting the changes that end-users need to know about and specifying the information required about a change, the guidance reduces the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users can stop building extensive inventories to mitigate against the perceived risks that arise from proposed changes.
Marissa Patrick, Associate Director at Merck & Co., Inc., Kenilworth, NJ, USA, added, “This is a great example of continuous improvement in an area that’s pretty grey. It puts some guidance out there where little is available.”
The industry-aligned paper is relevant to all raw materials used to produce biopharmaceutical products, including (but not limited to) cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients.
The team looked at the approaches used in other industries, such as semi-conductor and nuclear. It decided that a similar approach to SCNs could be adopted in the biopharmaceutical supply chain because of the greater maturity and experience in this space in these other industries.
This paper specifically focuses on raw materials and complements BioPhorum’s existing Change Notification: A guide to change notification packages for single-use manufacturing systems.
It also relates to BioPhorum’s 2019 industry standard Raw material: A holistic approach to raw material risk assessments through industrial collaboration, which gives an aligned industry perspective on the risks associated with raw material qualification in biopharmaceutical manufacturing and a step-by-step method to assess raw-material risk. It highlights some of the most impactful characteristics for raw materials and the types that the biopharmaceutical industry is most interested in when understanding supplier changes.