Regulators need to rethink ‘current’ GMP requirements, says ex-FDA exec

Adapting current good manufacturing practice (cGMP) to innovative technologies is a challenge for regulators, ex-US Food and Drug Administration (FDA) executive David Chesney told delegates at Dublin’s BioPharma Ambition Conference yesterday.

The general manager of DL Chesney Consulting said this issue stems from the fact many ‘current’ regulations were created in an earlier era, before numerous present-day technologies existed.

A major revision of US GMP in 1978 – finalised in 1979​ – brought ‘current’ regulations 21 CFR Parts 210 and 211​ up to date almost 40 years ago, and only relatively minor changes have been made since then.

“So we sit here, in 2018, with the US enforcing a regulation that calls itself ‘current’,” ​said Chesney.

“Regulators need to strike a balance between protecting the public from unreasonable risk and avoiding inhibition or restriction of technological advance.”​

Changes in the foreseeable future?​

Despite this need to advance alongside rapidly changing technologies, Chesney said he does not predict major modifications will be made to GMP legislation in the near future.

Today, the FDA relies on three strategies to keep GMP ‘current,’ he said: litigation (which leads to precedent), issuance of binding regulations, and issuance of non-binding guidelines.

Other non-binding methods used to communicate the FDA’s current thinking in the US – and in places that supply to the US market – include Warning Letters.