The flow of quality drug product onto the market relies upon controlled and consistent pharmaceutical manufacturing practices. While drug manufacturers use many methods to help them standardize their processes, inconsistencies often persist in pharmaceutical production from site-to-site and across multiple points in the drug development timeline, from clinical trial manufacturing to commercial manufacturing.
To help pharmaceutical manufacturers address this issue, the International Conference on Harmonization (ICH) has released guidelines on developing and implementing a manufacturing control strategy. To begin this process, pharmaceutical manufacturers must first audit their current processes and perform a risk analysis to determine which steps in the production line have the most impact on the quality and consistency of the final product.
Manufacturing control strategies can be put in place to support control of any number of variables involved in drug manufacturing, including raw materials, packaging materials and process steps. Once implemented, a manufacturing control strategy is not only beneficial for pharmaceutical companies to help them avoid product launch delays and quality concerns; patients benefit greatly from being able to rely upon the quality and increased production efficiency of drug products.
I sat down with Steve Murray, Principal Consultant for Werum IT Solutions America, Inc. to get a better understanding of the importance of implementing a manufacturing control strategy, and learn about some of the hurdles pharmaceutical manufacturers face when developing such a system. Murray has over two decades of experience working with life sciences manufacturers including setting up manufacturing execution systems (MES) designed to make the pharmaceutical production line more efficient and trackable.
Murray will also be the speaker for an upcoming webinar on successful implementation of a manufacturing control strategy. Register now to save your spot for this informative event for pharmaceutical manufacturers.
What challenges do pharmaceutical manufacturers face today?
Pharmaceutical manufacturers have challenges including manufacturing, pricing, distribution, and drug discovery. All of these challenges need to be supported by the data required for quality and regulatory compliance. The industry needs to get to a data management approach to help them control products from drug discovery through the manufacturing process.
The traditional focus has been on controlling products at the drug discovery stage. However, the industry and the regulators of many nations are pushing for a more holistic view – what we’re calling, the “manufacturing control strategy” – which is really managing that data through the entire life cycle through manufacturing.
Do the ICH guidelines on implementing a manufacturing control strategy affect large, mid-size and small pharma and biotech companies equally?
Most countries in the world have their own regulatory body that controls drug delivery. In the US, it’s FDA. Because of the numerous regulators, pharmaceutical manufacturing companies need to comply with different requirements just to sell a product in Canada, the US, the EU, Japan, Mexico, etc.
The ICH is an effort in which those regulatory bodies from all those countries, primarily Europe, US and Japan, are trying to align what their requirements are so the manufacturers don’t have to deal with those different requirements. That would affect large and small manufacturers just the same.
What is meant by the concept of “right first time?”
The consistency that you get out of standardizing things and enforcing how you do things through a use of an MES, allows the regulatory process that goes on within each company to be more standardized. Each producing company has a lot release process and a quality metric process, and all of those things can be different if the manufacturing process is a little different.
Standardizing how things are done enables those things to be done right the first time, meaning you don’t have quality people weighing in with concerns because it was done a little differently at one site versus the other. If there is an issue that could be quality-impacting, the manufacturers are able to address it through systems and processes that they have.
How can life sciences companies encourage collaboration between the different departments (e.g., QA/QC, Process Development, Manufacturing Operations, Engineering, Automation, IT) that are involved in pharmaceutical production?
The most important thing is a management emphasis on the need for that collaboration. In many cases, companies don’t perceive there’s a need for that collaboration across the quality, manufacturing and drug discovery departments, so those groups tend to all exist in isolation. Some management support for the idea that those departments have to work together in order to best serve their patients and their customers can help to encourage or force that collaboration.
What are the best practices for implementing a manufacturing control strategy?
Many of these manufacturing companies have sites all around the world and they tend to do things differently in every location. This manufacturing control strategy can be best supported by standardization of processes across those different locations.
In the upcoming webinar, we’re going to get into how a manufacturing control strategy is supported by an MES. We’ll also get into best practice for process harmonization.
For more information on how manufacturing control strategies can be put into place, including case studies outlining best practices, register now for Werum’s upcoming webinar titled, “Data Integrity and the Manufacturing Control Strategy for Life Sciences Manufacturers.”
What challenges has your pharmaceutical manufacturing organization faced when implementing a manufacturing control strategy? Share your experiences with others in the comments section below!