FDA Guidance for Submission of Documentation in Applications for Parametric Release

In February, the Food and Drug Administration (FDA) published the Guidance for Industry of  "Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes".

For submitting new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report, this guidance should give recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat.

The small number of samples required for testing, which restricts the ability to capture those microorganisms dispersed in a large volume, and  the limited ability of the prescribed culture media to stimulate growth of all potential microorganisms limits the detection of contamination by sterility testing. Thus data from the in-process-control of a validated sterilisation process can maybe provide more exact information regarding product sterility. Parametric release allows manufacturers to replace sterility testing of samples drawn from the finished product as a release criterion with acceptance criteria for the control of identified process parameters.

Therefore, in some cases, Parametric Release will be a possibility for the pharmaceutical manufacturer. FDA has accepted the practice of parametric release for drug products terminally sterilized by moist heat since 1985. Parametric release, described in the International Conference on Harmonisation (ICH) Q6A (ICH 2000),10 is endorsed by regulatory and/or pharmaceutical manufacturing groups in the US (PDA 1999, USP 2009), EU (PIC/S 2007, EMEA 2001), and Japan (Sasaki 2002).

More details can be found here.

The EMA published a new draft "Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)" in 2010. The recent guidelines, adopted in the course of the international harmonisation process, like ICH Q7, Q8 and Q9 facilitate to apply a similar release strategy to tests other then sterility. You can read more details here.

The ECA "3rd European Microbiology Conference" in Barcelona, Spain, from 4-5 May 2010 covers, amongst others, the topic of Parametric Release with lectures from regulatory authorities and industry.

Axel Schroeder
On behalf of the European Compliance Academy (ECA)

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