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Do you need help scaling-up your manufacturing line?
If you are reaching the limits of your production capability and need to plan for the next stage of manufacture to achieve projected volumes, CDP can help you to determine an appropriate scale-up strategy, ensuring a sound return on capital investment and a smooth transition to higher volumes.
Our manufacturing team will review your product and current processes to understand the quality-critical manufacturing steps and any existing controls. Based on these assessments and an understanding of your projected volumes, we can recommend suitable options for ramp-up. This may be anything from semi-automated work stations through to multi-cavity tooling and high-speed, fully-automated production facilities. Using a risk-based approach, CDP will work to ensure that any aspects of the process that impact product quality are, wherever possible, essentially unchanged during scale-up to minimise the time and cost of process validation.
We can prepare detailed equipment specifications enabling meaningful, like-for-like bids to be obtained. With our knowledge of equipment providers around the world we can ensure that appropriate suppliers - including technical, regulatory and geographic considerations - are contacted to provide bids. Once a supplier has been instructed, we can act as an independent reviewer of the system design and risk assessments as well as bringing our experience to bear in reviewing the proposed test and qualification protocols for medical or other regulated products.
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