India cannot be overlooked as its pharma and biotech plays an intrinsic role catering to the global requirements for analytical testing said Jennifer L Riter senior director Analytical Services West Pharmaceutical Services Inc The need for analytical services globally has grown over the years especially with the new standards regulatory expectations and guidance around packaging delivery systems and combination products The complex drug development and resource constraints drive the need for pharma and biotech manufacturers to seek partners for outsourcing analytical testing services she added Analytical testing services for combination products and delivery systems are trending as biopharmaceutical manufacturers want to partner with contract labs Navigating the requirements and putting together an appropriate testing strategy for combination products based on risk assessments is key to bringing these products to market Riter told Pharmabiz Moreover data integrity and management are a large focus for analytical testing laboratories There is need for appropriate processes to be in place to meet the regulatory expectations around data integrity Artificial intelligence too has begun to play a role to collect and analyse data It is in light of the potential impact that digital technologies may have that the Wests Digital Technology Center was opened in Bengaluru earlier this year to support its efforts in e-commerce digital marketing the SAP S 4 HANA ERP roll-out digital manufacturing and product development including embedded solutions such as AI Internet-of-Things and smart devices she said There are advances in technology in the area of analytical instrumentation from sensitive Container Closure Integrity CCI equipment to LC-TOF instruments for detecting and identifying extractables from containment systems and devices Last year West focused on four critical areas extractables and leachables container closure integrity particle analysis and testing for packaging devices and combination products We continue to invest in our expertise and technology in the area of analytical services to support our customers needs To address this West introduced its Integrated Solutions program which brings together Wests primary packaging device analytical regulatory and contract manufacturing expertise in a single-source solution said Riter However it is challenging to find the expertise for certain analytical services especially with container closure Integrity analysis as well as performance and functional testing of devices It can be difficult to find candidates that have experience with the instrumentation and regulatory on what is needed to evaluate products Aside from finding the appropriate expertise for certain specialised analytical techniques there is also a need to make sure there is an understanding of the current requirements for testing combination products In addition there are always new technologies and techniques that are being introduced Hence it important to keep a finger on the pulse of novel technologies she said Comments