Parametric Release and Real-Time Release Testing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Parametric Release and Real-Time Release Testing
Parametric release and real-time testing use manufacturing data to ensure that products are made according to defined standards. PharmTech talks to Boehringer Ingelheim's Heribert Hausler about these issues.

Pharmaceutical Technology
Volume 36, Issue 5, pp. s46-s47

PharmTech: Will real-time release testing replace the final release procedure?

Häusler: The main benefit of RTR testing when combined with quality by design and process analytical technology (PAT) tools is increased quality assurance for patients. In addition, such a strategy can lower manufacturing costs through improved yields, less waste, faster cycle times, and fewer deviations and rejects.

Process understanding and the definition of a robust control strategy are key aspects of RTR. The interaction of material parameters and attributes, as well as the dynamics of processes, must be taken into account, and are one important part of submission dossiers for marketing authorisations. As such, when implementing RTR systems it is essential to use PAT to efficiently monitor and record all quality-relevant parameters. In this area, there have been a number of improvements, including advances in NIR- and Raman microscopy, fluorescence microscopy, image analysis and laser-based methods. Using chemometics and multivariate analysis, it is now also possible to monitor production processes in real-time. However, a move towards RTR is not only about using advanced analytical and physical measurement techniques, but also involves performing statistical calculations on the resulting data masses. Importantly, regulatory authorities worldwide have to accept the move from final product testing to RTR applications. RTR has to be accepted by all regulatory authorities because the current varied acceptance can be a major issue. The equivalence between RTR-testing and pharmacopoeial testing must also be explained.

If one wishes to implement new tests and procedures, then it is important to adapt the whole quality assurance system. This approach is mandatory for compliance. The new quality system must also be aligned with ICH Q10.

These steps constitute the transition from rigid to risk-based cGMP, and a mindset change from reactive to proactive quality thinking, which could be quite a challenge. In particular, there will be a huge impact on qualified persons or other persons responsible for product release. Specifications will need to be elaborated carefully, and the definition of deviations that require investigation and the process to declare analytical results as outliers or invalid data must be described in SOPs.

RTR will be implemented over time as industry understanding increases and regulatory expectations are clarified. There is a long road ahead, but as the saying goes: a journey of a thousand miles begins with a single step.

Heribert Häusler is head of quality systems excellence at Boehringer Ingelheim GmbH (Ingelheim),
.

References

1. EMA, Note for Guidance on Parametric Release (March 2001).

2. EMA, Guideline on Real Time Release Testing (February 2010).

3. 21 CFR Part 11 Title 21 (April 2010).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
Source: Pharmaceutical Technology,
Click here