Related Vendors
Expectations from User Industry
With FDA rules getting stringent, it calls for the customers to adhere to more compliance and follow the GAMP5 standards more aggressively. “Subsequently, the automation vendors should not only provide productivity and flexibility but also help customers meet the standard safety and compliance requirements. ‘Counterfeiting’ in the pharmaceutical industry has witnessed a huge increase in the recent past. Hence, it’s important for brands to protect their products and identity. PAT helps reduce a manufacturer’s go-to-market time by indicating the deviations from the SOPs real time,” says Maennl.
He further adds, “Following are our expectations from the end-users which would help us increase their productivity and efficiency: a very well defined user requirement speciation (URS) document; early involvement in the project right from the conceptualization stages; effective change control measures implemented and followed at the customer end; a tighter and stringent operation controls at the customer end; efficient and trained workforce on the production floor; embrace, implement and practice the latest trend with automated manufacturing practices.”
Looking into the Crystal Ball: Trends and Predictions
In general, rising cost pressure in production will press manufacturers to further improve productivity with respect to OEE over the next few years. “Large-scale production of generics will increasingly be re-located to the emerging markets, calling for durable and highly productive machines. To maintain and improve a plant’s OEE, aftermarket services are becoming more and more important. A processing and packaging specialist who wants to keep pace with the industry needs to offer comprehensive consulting services all over the globe,” affirms Harbauer.
OEE is equally important when it comes to the development and market introduction of new pharmaceuticals. So far, the production of small batches has been quite an expensive venture but with the optimization of machines in terms of flexibility, automation, easy changeover and scale-up, the situation has changed significantly – and will continue to do so in the future. These improvements enable manufacturers to develop new drugs with short time to market, while complying with strict regulations.
* The author works as a Deputy Editor for Vogel Business Media India
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