2012 Corporate Capabilities - Spectroscopy

www.spectroscopyonline.com
December 2011 Spectroscopy 26(12) 19
contained in the appendixes (21). The
first edition had only three appendixes,
whereas the second edition has 12 appendixes
to describe items in more
detail. Furthermore, where a topic has
been covered in sufficient detail in the
main GAMP guide, the reader is referred
to it.
New Appendixes
The appendixes of the second edition
GPG are listed below:
1. Comparison of USP and
GAMP GPG
2. Categories of Software
3. System Description
4. Application of EU Annex 11 to
Computerized Lab Systems
5. Data Integrity
6. Definition of Electronic Records
and Raw Data
7. Activities for Simple Systems
8. Activities for Medium Systems
9. Networked Chromatography Data
System with Automated HPLC
Dissolution
10. Instrument Interfacing Systems
including LIMS and Electronic
Notebooks
11. Robotics Systems
12. Supplier Documentation and
Services
From our point of view, Appendix 1
is the most important because it brings
together the two approaches in a single
discussion. A good inclusion in the GPG
are discussions on the latest regulatory
requirements: Appendixes 4 and 6 address
the impact of the new EU GMP
regulations of Annex 11 (25) and Chapter
4 (26), respectively. The increased
emphasis by the regulatory agencies on
data integrity also has been addressed,
in Appendix 5, which helps laboratories
meet the challenge of data integrity
in an electronic environment. Validation
activities for simple, medium, and
complex systems are discussed in four
of the appendixes. Finally, there also is
a discussion of supplier documentation
and services and how to leverage and
use them.
AIQ and CSV. Where Will We Be in
the First Quarter of 2012?
The title of this column asked if integration
of USP and the GAMP
GPG for validation of laboratory computerized
systems was possible. With
the current versions of the two documents,
this is not possible, because of
the divergent approaches explained
earlier.
However, the first quarter of 2012
brings the promise of integration,
because both two publications will be
updated at that time. Our stimulus
to the revision process paper for USP
will be published in Pharmacopeial
Forum and will detail the risk
assessment and the subdivision of
Groups 1, 2, and 3 (20). The second
edition of the GAMP GPG for the
validation of laboratory computerized
systems also will be published (21). In
it, the categories will be eliminated
and replaced with the GAMP software
categories. Both documents have
common elements and approaches,
because the teams have collaborated
to achieve this.
So, back to the question posed in
the title: Is integration possible between
and the GAMP GPG?
Yes, it is, and with the updates of
these two documents, we are moving
toward that ideal. However, life is not
perfect, at least not yet. GAMP software
category 2 needs to be reinstated
for full alignment with Group
B instruments and to allow more
explicit flexibility in the laboratory
computerized systems GPG. Qualification
of laboratory instrumentation
is not a term that is recognized by
GAMP because they have decided to
use verification instead, yet ISPE provides
guidance documents on facility
commissioning and qualification (27)
— so where is the problem? The revision
of USP also uses the term
validation, which is avoided in the
GPG. However, these differences are
easily surmountable with intelligent
interpretation and implementation of
an integrated approach to AIQ and
CSV in your analytical laboratory.
In the future, we hope that we will
have USP providing the regulatory
overview of analytical instrument
qualification and linking to the relevant
requirement chapters of USP that contain
the specific instrument parameters
to qualify. The GAMP laboratory GPG
could then provide guidance on how
to achieve this as well as the validation
of the software elements (from a single
embedded calculation to the whole application
or system) — a unified and
integrated approach.
If this occurs, then the pharmaceutical
industry can meet the existing
approach that ISO 17025 (28) states in
section 5.5.2:
Equipment and its software used for
testing, calibration and sampling shall
be capable of achieving the accuracy
required…
This implies an integrated approach
to ensure that the analytical instrument
and the associated software work,
as specified for the intended purpose.
Nothing more and nothing less.
Acknowledgments
The authors would like to thank the
following parties for their contribution
to developing the stimulus to the revision
process, the second edition of the
GAMP Laboratory GPG, and review of
this column:
• Horatio Pappa, USP
• Members of the GAMP GPG for
Validation of Laboratory Computerized
Systems were Lorrie Schuessler
(GlaxoSmithKline), Mark Newton
(Eli Lilly & Co.), Paul Smith (Agilent
Technologies), Carol Lee (JRF
America), Christopher H. White
(Eisai Inc.), Craig Johnson (Amgen
Inc.), David Dube (Aveo Pharmaceuticals
Inc.), Judy Samardelis
(Qiagen), Karen Evans and Kiet
Luong (GlaxoSmithKline), Markus
Zeitz (Novartis Pharma AG), Peter
Brandstetter (Acondis) Rachel Adler
(Janssen Pharmaceutical), and
Shelly Gutt (Covance Inc.).
• Mark Newton, Paul Smith, Lorrie
Schuessler, and Horatio Pappa for
providing comments on the draft of
this column.
References
(1) Guidance for Industry, General
Principles of Software Validation,
FDA (2002).
(2) Guidance for Industry, Computerized
Systems in Clinical Investigations,
FDA (2007).