Improving product quality and reducing manufacturing costs were seen as the top goals for the future, the report found.
“We are seeing a desire by industry to increasingly adopt tools and methods to quantify the value and quality of their work and, consequently, adapt their manufacturing techniques to enable continuous improvement and improve product quality,” CPhI said in their report on a survey of Big Pharma, API companies, CMOs and other manufacturers.
Quality by Design and Process Analytical Technology are quickly becoming tools companies are using for continuous improvements, as 16% and 11% of respondents said they were seeking these tools out, respectively. “We may see a growing uptake of 6 sigma and Lean which have both been shown to be effective in waste reduction- a vital objective for manufacturers,” CPhI says.
Girish Malhotra, president of Epcot International, noted, “Process improvements could save billions in cost, lowering the price of drugs and opening up newer markets to pharma. This has to be the short and long term goal. Process improvements made in existing approved products have to be approved by the regulatory bodies.”
Despite the need for higher quality in manufacturing, 11% of respondents said that they do not test all incoming raw materials sourced to their facilities, though almost half said they connect with suppliers weekly.
Of the 89% that are testing raw materials sourced to their facilities, compendial testing was an unrivalled method of choice (81%) and one that “is likely to remain the principal approach over the next few years,” as other methods including gas chromatography, liquid chromatography and mass spectrometry are being used by just 15% of the industry to test sourced raw materials, CPhI found.
Responses also suggest that outsourcing is becoming a more important strategy in manufacturing, as 41% said that they are outsourcing more of their manufacturing to other organizations.
Malhotra concluded, “The current manufacturing model is also an obstacle. Regulatory bodies cannot drive excellence in companies. It is my hope that the industry will review the model and drive itself to excellence. Unless this happens regulatory bodies through additional regulations will force the industry to drive to excellence. This will only increase costs.”