COMPLIANCE IN THE LAB: INFORMED PERSONNEL INDISPENSABLE
The Foundation for every effective and high-quality medicine is laid in the laboratory. At the beginning, there are the laboratories for research and development, later the laboratories of the analytical and microbiological quality control.
The importance the work in the laboratory of the pharmaceutical development and manufacturing has is also reflected in the significantly increased attention authorities devote to quality management and laboratory compliance. That's why responsible staff has to focus even more on the establishment of GLP and GMP standards in deployed systems and methods. These include for example:
- Understanding of GLP and cGMP requirements and compliance with appropriate written processes
- Performance, transfer and validation of analytical methods and microbiological tests
- Calibration and qualification of equipment and systems
- Computer validation
- Training
In many areas, there was considerable progress in the past few years concerning new methods or in the improvement of the sensitivity of methods used. The development of rapid microbiological methods, e.g. based on PCR (polymerase chain reaction), mass spectrometry or Ultra High Performance Liquid Chromatography (UHPLC) in analytics open new opportunities for the control and release of drugs and active ingredients. At the same time new types of medicines require the development of new methods, because classical analytical test methods are not suitable to their control. This specifically includes medicines with biological or biotechnological origin , such as cell therapy, ATMP, gene therapy and others. An example would be the MAT (monocytes activation test) as alternative pyrogen test.
A good laboratory performance not only includes qualified equipment, validated processes and methods and corresponding systems for data processing and analysis, though. It also comprises employees who are on the cutting edge of these developments. To ensure the validity of systems such as "Laboratory Information Management Systems (LIMS)" pose additional challenges.
Recommendation
22/23 January 2025
HPLC Data Integrity - Live Online Training
No matter whether we are talking about analytics, bioanalysis or microbiology, for laboratory managers as well as laboratory staff it is difficult to stay on top of science and technology and to be up-to-date with regard to current developments.
Training courses may be appropriate in certain cases. However, frequently they are not focused enough, cannot fulfill specific training requirements and do not provide enough time for a free information and experience exchange. Large trade shows, on the other side, do provide professional and technical information, but mostly lack an opportunity for visitors to exchange experience on a personal level and therefore to receive unbiased information. Further, for visitors and exhibitors with the focus "Pharma" these shows are often too large and unspecific, requiring visitors to go long distances and to spend a lot of time to get to interesting exhibitors. For specialised exhibitors focusing on applications in the lab this often also means many visitors, but little professional exchange and valuable leads.
Therefore, PharmaLab will start in 2013. This new laboratory Congress' goal is to provide lab employees in the pharmaceutical industry with current knowledge relative to developments, applications and validation in analytics, bio-analysis and microbiology. It also aims at facilitating the exchange of information and experience with regard to GMP compliance in laboratories.
Focus on analysis, bio-analysis and microbiology
In total six conferences focus on the areas of analysis, bioanalysis and microbiology. From 13 to 14 November more than 40 speakers from industry, contract laboratories and from authorities will report about regulatory changes, hands-on experience in the lab as well as about the implementation and validation of methods.
The subject area analysis is at the heart of two conferences.
Almost all organic contaminants are determined by chromatographic and similar combined methods. New developments in HPLC and in particular the increasingly important UHPLC are therefore addressed in one of the two conferences. It will also cover software for method optimising (according to the principles of QbD) and the validation of UHPLC methods.
In the second conference the dream of many analysts will be the subject: the paperless lab. In particular it will involve how the requirements - giving up classical paper documentation, process acceleration in the laboratory and cost savings - on the one hand and ensuring the integrity and security of all data and records on the other can be brought together.
A third conference will focus on the field of bio-analysis - and specifically on the expectations of the licensing authorities and the challenges involved in the validation of bioassays, but also to the importance of orthogonal methods.
Three conferences in the field of Microbiology round off the conference programme.
The statistical significance of sterility testing is certainly subject to discussions - just like microbiological background issues like the inhomogenous distribution of contaminants. However, reality is that sterility testing is required for many pharmaceutical products. But what is the best way of sterility testing? Testing in cleanrooms or in isolators? And do rapid Methods provide the potential for improvement? The conference on sterility Testing will center on these questions - and possible answers.
Recommendation
Tuesday, 4 February 2025 9 .00 - 17.00 h
Reference Standards - Live Online Training
Testing of endotoxins poses several challenges as, e.g., masking effects, inhibitors or potential interferences. furthermore, contamination of biologicals by non-endotoxin pyrogens that are not detectable in LAL test is quite possible. But for a stable high throughput routine testing, the LAL is essential. New developments in endotoxin as well as in pyrogen testing - like latest findings in the field of protein masking, the glucan assay and the Depyrogenation - are thus in the center of attention of another conference.
The third Conference of this subject area finally takes a look at the testing of raw materials and Excipients and the necessary supplier agreements and provides comprehensive information to comply with the Pharmacopoeia, the necessary tests and the testing of critical substances.
Trade fair for specialized providers accompanies conferences
The Congress' parallel large exhibition which will be located centrally between the conference rooms will also contribute to the information exchange. There, more than 30 specialised providers will present latest systems and methods as well as services and therefore allow the comparison of available equipment.
Author:
Axel H. Schroeder & Dr Günter Brendelberger
CONCEPT HEIDELBERG
