The EMA has released guidelines extending use of real-time release testing (RTRT) beyond terminally sterilised products.
Adoption of the guidelines allows a broader spectrum of biopharma manufacturers to rely on process controls, instead of end-product testing, to assure drug quality. Use of RTRT can, in some cases, give greater assurance of quality and the European Medicines Agency (EMA) is supporting the switch.
“The application of RTRT may offer advantages to a manufacturer and from a regulatory point of view the enhanced knowledge gained is welcomed, however it is not a mandatory requirement. Potential benefits are to enable real-time control and process intervention”, the EMA wrote .
Pre-authorisation by the competent authority is needed to adopt RTRT. To gain approval the EMA asks manufacturers to address quality aspects specific to the product in a new market authorisation or a variation.
“RTRT may be introduced as a part of an application that is based on an enhanced product understanding of what is critical for product performance or may be introduced following a variation of an existing market authorisation when more experience has been gained”, the EMA wrote.
Manufacturers of APIs (active pharmaceutical ingredients), small molecule finished dosage forms, biologics, or other drug products can apply to adopt RTRT. In each case the EMA gives examples of potential approaches but encourages manufacturers to extend the use of RTRT beyond these roles.
The EMA tells manufacturers its examples “are not intended in any way to limit the scope of the application of RTRT” and it is impossible to give specific details of how to use the approach. Instead the EMA will assess each case individually to ensure quality requirements are met in RTRT.
Recommendations by the EMA build upon work at the International Conference on Harmonisation (ICH). With the ICH knowledge in place regulators and drugmakers are looking closely at RTRT.
In November Christine Moore, of the office of new drug quality assessment at the US Food and Drug Administration (FDA), told in-PharmaTechnologist the Agency “encourages and supports” RTRT. Three months earlier a Pfizer executive told the FDA the company is “aggressively” pursuing RTRT.