Biomanufacturers need for supply chain compliance and the fantastic growth in the biopharma market is resulting in a number of our manufacturing facilities having back-to-back customer audits planned until June 2023, longer for some of our sites producing the most in-demand technology. Substantial growth, particularly for single-use systems, and speed to market brought about by the vaccine race, has triggered capacity expansion globally and the audit burden is now huge and affects both drug manufacturer and system supplier alike.
So, can auditing be fast-tracked without compromising quality and accuracy? And if auditing as a process can be simplified, will it still fall within the tight boundaries set by regulatory authorities that help define Supply Chain Quality Management? The answer to both these questions is yes. The current way we, as an industry conduct audit processes, can be simplified by joint audit programs.
A joint audit is an audit by an independent auditing company representing multiple customers that can access the resulting audit report. Although not an entirely new concept, the idea of joint audits and sharing audit data was put practically into motion for biomanufacturers, by BioPhorum, after recognition of the growth of single-use systems, expansion of existing sites, and the recent explosion of new manufacturing facilities. Effectively this joint audit is a collaboration between biomanufacturers and suppliers with the primary objective: to relieve audit burden for both parties and standardize audit practice. At its best it is a united solution to an industry-wide pain point.
The reward of this process is that each standardized audit becomes a licensable report that subject to approval, can be accessed by the many. Learn how you can save costs and time by having access to licensable joint audit reports.