New EMA Guideline on Real Time Release Testing
![Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online Training](files/eca/userImages/training.img/Z-ECA-Stability-Studies-Shipping-Distribution-LOT.jpg)
Recommendation
12/13 September 2024
Medicinal products must comply with the requirements stated in the authorised specifications before they can be released for sale. Under certain circumstances an alternative strategy may be allowed for the systematic end-product testing. So far, this concept has been primarily used for the sterility testing of products terminally sterilised. As defined in the ICH Guidelines Q8, Q9 and Q10, it is now possible to extend such release decisions to other applications. This approach is called "Real Time Release Testing (RTRT)".
The EMA has published a new Guideline on Real Time Release Testing (formerly Guideline on Parametric Release) which should enter into force in October 2012.
The Guideline is valid for active substances, intermediates and finished products. Yet, the introduction of RTRT always requires pre-authorization by the competent authority. Even if an authorisation is available for RTRT, a specification has to be established and each batch of a product should comply with it if tested. Basically, a specification is also necessary for stability studies.
The condition for the application of RTRT is adequate validation of the RTR test method. Substantial comparative data through parallel testing of production batches are expected.
If the test results of RTRT fail or are trending toward failure, RTRT may not be simply substituted by "normal" end-product testing. The results of RTRT should be given in the Certificate of Analysis as "complies if tested" with a footnote: "Controlled by approved Real Time Release Testing".
Usually, RTRT comprises a combination of process controls which may utilise process analytical technology (PAT) instruments and tools, e.g. NIR or Raman.
RTRT can also apply to continuous manufacturing processes for the manufacture of APIs.
RTRT will be one of the key topics addressed at the QbD/PAT Conference organised by the University of Heidelberg on 26/27 September 2012 in the Marriott Hotel in Heidelberg, Germany. This year, the conference will welcome many top-class speakers who will come for the first time to Heidelberg.
Please also see the complete EMA "Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)".
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
24.07.2024FDA Warning Letter to Chinese OTC Manufacturer for Lack of Analytical Test Data
10.07.2024Pharmeuropa: Two Revised Chapters on Dissolution Testing published for comments
03.07.2024FDA Warning Letter: GMP Requirements also apply to HPLC Analyses for Internal Use
12.06.2024NMPA Announcement on Application of ICH Q2(R2) and Q14 Principles
22.05.2024Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 1
22.05.2024FDA Warning Letter to Contract Testing Laboratory in Uruguay due to Data Integrity Violations