In April 2020, IPEC released a position paper describing its position on the relevance of data integrity guidance documents to the manufacture and supply of excipients.

“Maintaining data integrity is fundamental to the application of GMP. Published regulatory guidance defines data integrity requirements for finished drugs/medicinal products and active ingredients [1-5]; however, these guidance documents include requirements that may not be easily adaptable to the manufacture of excipients.”

Download the position paper here.