Pharmaceutical Technology Europe - March 2012 - (Page 11)
INTERVIEW
Parametric release and real-time release testing
Compliance with release specifications can be demonstrated by testing the final product, but alternative strategies are available. Parametric release and real-time testing
use manufacturing data to ensure that products are made according to defined standards.
What is the difference between
parametric release and real-time
release testing?
Parametric release can only be
applied to products terminally
sterilised in their final containers by
steam, dry heat or ionising radiation,
but recent guidelines adopted in the
ICH context (ICH Q8, Q9, and Q10)
now enable a similar release strategy
to be adopted for other tests too. This
approach is called real-time release
testing (RTR testing), and can be
applied to both new and established
products. As with parametric release,
RTR testing provides assurance
of final product quality based on
information collected during the
manufacturing process. The basis for
establishing RTR testing mechanisms
involves combining quality riskmanagement
principles, enhanced
product knowledge and process
2 SPECIAL FEATURE
11 PARAMETRIC RELEASE
understanding, as well as applying
an adequate pharmaceutical quality
system.
What preconditions are required
for parametric release of sterile
medicinal products?
Parametric release is defined by the
EMA as a sterility assurance release
programme, where a demonstrated
control of the sterilisation process
enables a company to use defined
critical process controls in lieu of the
sterility test to fulfil the intent of 21
CFR 211.165(a) and 211.167(a).
The entire sterilisation process must
be described, and process validation
reports have to comprise heat
distribution and heat penetration
studies for at least three runs for each
load pattern used, according to good
validation practices. Microbiological
qualification must also show sufficient
efficacy at the minimum level of
7 REDUNDANT FILTRATION
12 COLUMN CRUNCH
the cycle, including information on
the biological indicators used (type,
D-value, Z-value, and stability) and
bioburden characteristics (number,
type, and resistance), as applicable.
Will real-time release testing replace
the final release procedure?
Importantly, regulatory authorities
worldwide have to accept the move
from final product testing to RTR
applications. The equivalence between
RTR-testing and pharmacopoeial
testing must also be explained. 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. RTR
will be implemented over time as
industry understanding increases and
regulatory expectations are clarified.
8 NEWS BITES
13 PEER REVIEW
Read the full interview at
PharmTech.com/parametric
Heribert Häusler is head of quality
systems excellence at Boehringer
Ingelheim GmbH (Ingelheim).
haeusler@ing.boehringeringelheim.com
9 BLOG
14 TOP TECH
Heribert Häusler
http://www.PharmTech.com/parametric
Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - March 2012
Pharmaceutical Technology Europe - March 2012
Contents
Innovations, drivers and trends in adjuvant filtration
Focus: Redundant filtration
News Bites
Blogs Abridged
Interview: Parametric release and real-time release testing
Column Crunch: Counterfeits and outsourcing trends
Evaluating drug impurities
Top Tech
Pharmaceutical Technology Europe - March 2012
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201211
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201210
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201209
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201208
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201207
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201206
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201205
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201204
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201203
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201202
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201112
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201111
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201110
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201109
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201108
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201107
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201106
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201105
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201104
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201103
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201102
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201012
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201011
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201010
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201009
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201008
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201007
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201006
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201005
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201004
https://www.nxtbook.com/nxtbooks/advanstar/pte_201003
https://www.nxtbook.com/nxtbooks/advanstaruk/pte_201003
https://www.nxtbook.com/nxtbooks/advanstar/pte_201002
https://www.nxtbookmedia.com