Building effective supplier relationships can help improve quality control and operational efficiency, reduce time to market, and produce higher yields.
Current good manufacturing practices (cGMP) are required for the safe manufacture, testing, and quality assurance of pharmaceutical and biopharmaceutical products worldwide. GMP procedures are the basis for globally established regulatory guidelines and processes to ensure consistency, product reproducibility, and documentation for the traceability of all materials used in production, from raw materials to finished drugs.
Pharmaceutical and biopharmaceutical manufacturers who work with suppliers that have their own established cGMP manufacturing capabilities can do more than ensure regulatory compliance and approval of their products for sale in global markets. Building effective, collaborative relationships with cGMP suppliers can help contribute to improved operational efficiency, reduce time to market, and aid in maximizing process yields and quality.
Suppliers are a critical link in the pharmaceutical and biopharmaceutical supply chain that ultimately delivers value to the consumer. Pharmaceutical manufacturers can leverage the advantages inherent in their suppliers’ cGMP processes and capabilities to enhance three key aspects of production:
- Controlling consistency, stability, and yield when ramping processes up to full production
- Preventing cross-contamination and simplifying raw material usage
- Making better use of management of change (MOC) to manage risk
Collaboration on Process Validation
For drug manufacturers, securing well-defined, well-characterized, and consistently-supplied raw materials is an essential first step in ensuring pharmaceutical efficacy and patient safety and meeting regulatory requirements. Pharmaceutical and biopharmaceutical manufacturers who collaborate with cGMP suppliers understand the origin and flow of materials throughout their supply chains. Therefore, they are better able to develop products that comply with regulations region by region and can respond with confidence to regulatory inquiries related to materials used in their drug manufacturing process.
Equally valuable is the support that cGMP suppliers can provide as pharmaceutical and biopharmaceutical companies implement and refine their production processes for new products. At its core, cGMP manufacturing is highly controlled. cGMP suppliers follow precisely documented manufacturing processes, test and characterize the purity level of each finished material, and are able to demonstrate that, batch to batch, product purity and consistency remains within strict parameters.
The benefit to the manufacturer is both ease and efficiency: it is easier for them to resolve obstacles and optimize new processes faster, because they are utilizing materials with proven characterization and consistencies; and they are more efficient, because they know that, all other process factors being controlled, their new process will generate similar yields and similar purities according to design.
Strengthening collaboration between cGMP suppliers and manufacturers can yield these benefits, provided that there is sufficient openness and communication between trusted business partners. The benefits to this type of collaboration were made clear recently, when Avantor worked with a biopharmaceutical company as it began using our new High Purity Low Endotoxin (HPLE) sugars.
We know that certain impurities can impact the stability and yield of a protein. By working closely with the biopharmaceutical company and gaining a thorough understanding of their process, Avantor has been able to help reduce API degradation and improve the yield of their cell cultures, thereby generating real value for the customer and their patients.
Communication and transparent information-sharing (beyond the regulatory data sheet) were crucial in ensuring that the HPLE sugars we provided met the specific needs of the customer. Avantor worked closely with our collaboration partner to conduct detailed characterization studies to better understand the impact of elemental impurities and related substance impurities. Based on this information, we were able to implement a process to control elemental impurities below the 100 ppb level.
We were able to collaborate in this manner because we are a trusted supplier. That trust, in part, is derived from our history as a cGMP supplier with strong and well-established controls in place.
cGMP Materials in Production
For suppliers, cGMP impacts every part of the supply chain. It includes detailed audits, comprehensive supplier change notifications, and innovations they develop to improve security and reduce contamination risk in the way their products are packaged and delivered.
Collaboration between suppliers and manufacturers can lead to improvements in materials delivery and packaging that leverage the quality of the cGMP processes at the supplier level.
For example, standard cGMP practice for drug manufacturers, when receiving raw materials, is to subdivide, weigh, characterize, and document the quality and consistency of the ingredients they receive. This process, although essential, could be time-consuming and risk cross-contamination.
Using MOC to Foster Better cGMP Collaboration
Change is a constant in the pharmaceutical and biopharmaceutical industries—so cGMP suppliers and end-user manufacturers can use effective management of change (MOC) processes to ensure that both parties keep patient safety and product quality on-target.
The best suppliers have strong, well-established MOC processes that are fully integrated into their cGMP processes. They regularly evaluate and document changes in facilities, documentation, personnel, and operations and effectively communicate these changes to all affected users in the supply chain.
Some suppliers treat MOC as a simple regulatory, documentation step: if they change a process reactor “like for like,” they will simply note that the reactor was changed. Companies that, through collaboration with leading drug manufacturers and regulatory authorities, have developed stronger MOC processes, have begun to dig deeper. This is in response to growing interest in the issue of elemental purity (such as trace metal contamination) and its impact on pharmaceutical products and patient welfare.
Rather than just documenting the reactor change, they will measure and document any changes in elemental purity levels associated with that change and make sure it is communicated to end-users; that way, it can be used by the manufacturers to assess any impacts on process yields and stability.
‘Digging deeper’ and using MOC to facilitate better collaboration should include a more sophisticated approach to communication. At Avantor, every one of our products is classified under one of five tiers of change control notification—from the most highly regulated products manufactured to stringent global guidelines, to non-regulated, non-cGMP materials. That ensures that end-users always get the MOC notification that is most useful to keeping their cGMP processes on-track.
More Than an Acronym
Virtually all participants in the global pharmaceutical and biopharmaceutical supply chain need to be cGMP-compliant—first and foremost to satisfy regulatory requirements.
For global manufacturers seeking to build productive relationships with their suppliers, strong—and globally established—cGMP programs can provide the right framework for success. As an example, Avantor operates pharmaceutical facilities in the U.S., India, and Europe that are registered with the American FDA. In India, the facility is also registered with the Indian FDA, and all three locations operate under cGMP conditions in accordance with ICH Q7.
By collaborating with suppliers that make cGMP the foundation of their materials production and supply chain processes, pharmaceutical and biopharmaceutical manufacturers can improve their own cGMP performance, as well as achieve greater process efficiencies in key drug development and manufacturing.
About the Author
Nandu Deorkar, Ph.D., MBA, is Vice President, Research & Development for Avantor™ Performance Materials, which manufactures and markets high-performance chemistries and materials around the world under several respected brand names, including the J.T.Baker® and Macron Fine Chemicals™ brands.
During his more than 25-year career in materials technology research & development, Dr. Deorkar has worked on various aspects of chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer.
Dr. Deorkar earned his Ph.D. in Chemistry from the Indian Institute of Technology, Bombay, and his MBA from Fairleigh Dickinson University, New Jersey.