GMP Conference: Zoo and Data Management; Do they go together?

What distinguishes a crocodile from an alligator?

The visible tooth in the lower jaw makes the difference; crocodiles have one, alligators do not. And much more from the world of zoo animals was learned by the participants during the zoo tour in a nocturnal atmosphere at the 24th GMP Conference on December 4-5, 2018, in Leipzig. But of course, the focus was not on the zoo, but on GxP. Many innovations were on the agenda: new developments from the AMG, ATMPs, medical devices, digitalization, to name just a few keywords. But also soft topics like conflict and time management were part of the comprehensive program. Selected photos from Leipzig are embedded below on this page!

Innovation Safari

The conference was rounded off with an innovation safari at these companies in the Leipzig area:

- Fraunhofer Institute for Cell Therapy and Immunology IZI, D 04103 Leipzig, guided tour 1, Department GMP Cell and Gene Therapy, and guided tour 2, Department Therapy Validation
- Kühne+Nagel (AG & Co.) KG, D 04158 Leipzig
- Mibe GmbH Pharmaceuticals, D 06796 Brehna
- World Courier (Germany) GmbH, D 04347 Leipzig

Round Table Data Management (by Dr. Maria Brecht and Klaus Eichmüller)

Building on Mr. Klaus Eichmüller’s presentation on data management, the round table continued the discussed topic. After a brief inquiry about participants’ discussion wishes, the following topics were set as priorities for the round table:

- Archiving of measurement data files
- Raw data / measurement data
- Evaluation of manual integration
- Handling of legacy systems

Raw Data, Measurement Data

When starting with the topic of raw data, the initial situation of the mandatory backtracking of results to raw data as a basis in the definition was addressed. A comprehensive proposal from the audience includes backtracking to the first data acquisition: the signals along with the metadata. This would also ensure, for example, in evaluation systems, storage in a reprocessable format. Furthermore, the issue was discussed that in reality, not all data files are always reviewed. Participants unanimously agreed that, in the case of processable data, the printout of measurement data as the sole stored data record is sufficient.

Measurement Data in Simple Systems

A brief section of the discussion covered data acquisition of raw data with simple systems that display only a single value (such as viscometers, pH meters...). It was noted that, logically, no audit trail is necessary if no data is stored or if no data change is possible in the measurement system. To record the data, a second verification is needed, which cannot be covered by simply capturing the signal. In this context, transforming data into other systems was seen as particularly problematic.
The good idea of photographic recording of measurement values, evaluated, also requires that these images are additionally part of the evaluation. This has the advantage of easy documentation of the review.

Archiving

The period of archiving, considering legal requirements and the possibility of storing large data volumes, was generally considered not problematic. It was noted that data must be retrievable. To do this, data must be regularly re-imported. For data stored in a dynamic format, proof of processability must be provided. When asked which time intervals are considered regular, a risk-based approach should be used.

During transfer to an electronic archive system, the transfer process must be secured/validated. Checksums and hash value creation were mentioned as example controls of the process.

It was discussed that storage in archive systems, like backup systems, should be on physically separate servers (at least separated by fire compartments).

The discussion about generic data formats could only be satisfactorily answered for text files (pdf/A). The participants had no GMP-relevant experience with formats for analytical data such as AnIML!

Manual Integration of Chromatography Data

The discussion started from a participant’s audit presentation: The possibility of manual integrations is fundamentally considered a deviation, and methods should be adjusted until manual integration of measurement data is no longer necessary.

The discussion noted that, initially, during method development, automatic integrations should be attempted. It was generally accepted that this may not always be possible, especially in purity tests. There was consensus that, as a second step after method development, the procedure (described in an SOP) should be documented and the corresponding documentation ensured. A deviation occurs, for example, if the defined procedure was not followed. Performing manual integrations per se is not a deviation!

Legacy Systems

The final part of the round table was a brief discussion on handling legacy systems. Mr. Klaus Eichmüller clarified that, for systems purchased after 2011 that still do not meet the requirements of Annex 11, the understanding of classifying these as legacy systems is limited. For legacy systems from before the introduction of new requirements (1992 or 2011), which are still in use and do not meet the newly mandated functionalities, a risk assessment must be performed, and possibly a temporary workaround established. If necessary, decommissioning these systems should be prioritized.

These organizers supported PTS Training Service at the GMP conference:

- GQMA German Quality Management Association e. V., formerly DGGF: German Society for Good Research Practice e.V.
- Hochschule Albstadt-Sigmaringen: Pharmaceutical Technology Degree Program

Speaker Team

Thomas Brückner
BPI Federal Association of the Pharmaceutical Industry, Berlin

Richard Denk
SKAN AG, CH-Allschwil

Pharmacy Director Klaus Eichmüller
Darmstadt Government Presidency, Darmstadt

Dr. Nadine Frankenberg
SYNLAB Analytics & Services Switzerland AG, CH-Birsfelden

Dr. Jörg Neumann
Dr. Jörg Neumann Coaching and Consulting, Limburgerhof

Dr. Lothar Plaggenborg
Medac GmbH, Wedel

Prof. Dr. Christa Schröder
Hochschule Albstadt-Sigmaringen, Sigmaringen

Pharmacy Director Dr. Gabriele Wanninger
Government of Upper Bavaria, Munich

Dipl.-Psych. Peter C. Zimmermann
ISKOM Institute for Training, Communication, Organization, Neuss