Pharmaceutical manufacturing is governed by strict regulations designed to safeguard product quality and patient safety, but meeting those requirements remains a persistent challenge.
According to PMMI’s Trends and Challenges in Pharmaceutical Manufacturing report, a majority of manufacturers still struggle with complex documentation and reporting processes (71%), despite progress in areas like DSCSA serialization. This highlights a gap in digital readiness.
Digital documentation is crucial in order to efficiently meet reporting requirements, yet levels vary across organizations. Most CPGs (78%) report a mix of digital and manual documentation.
Despite this ongoing difficulty with documentation, only 21% of OEMs say customers ask for help in this area. This indicates an opportunity for OEMs and suppliers to play a larger role, by strengthening digital infrastructure or equipping teams with better data management capabilities.
Currently, OEMs report that their customers most frequently request help with the physical product testing (40%), packaging compliance (33%), and sanitation and cleaning (33%).
With a seeming disconnect between CPG needs and their requests of OEM partners regarding documentation struggles, OEMs and suppliers may want to emphasize their digital integration and reporting infrastructure capabilities.
“We do offer some regulation training and guidance, but not everything,” an OEM technical trainer said. “We certify our distributors on our equipment so they can advise end customers on how our machinery helps meet local compliance requirements. We also provide specific training upon request to help customers meet their compliance needs, such as when regulations require a certain number of training hours per year.”
SOURCE: 2026 Trends and Challenges in Pharmaceutical Manufacturing
For more insights from PMMI’s Business Intelligence team, find reports, including Trends and Challenges in Pharmaceutical Manufacturing, Automation in Food and Beverage Equipment Sanitation, and Knowledge Transfer for Machine Operators: From Paper to Digital Intelligence at https://www.pmmi.org/business-intelligence.
Download the FREE report below.
