ResourceLab Informatics
Robust Cleanroom Routine Environmental Monitoring
8 May 2017The FDA’s 21CFR part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemented Standard Operating Procedures (SOP) for cleanroom routine environmental monitoring and manual transcription of the test results still common practices the resultant opportunities for human error raises concerns over the integrity of the data in the final electronic record, no matter how safely the final record is stored. This paper describes how Quality Control instruments can be optimized for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.
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Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Electronic Laboratory NotebooksElectronic Laboratory Notebooks (ELNs) are becoming increasingly popular for documenting experimental processes and for lab data management. An ELN is informatics software which can be biology specific, chemistry specific, cross-disciplinary or web-based. Advantages of an electronic lab notebook include increased data protection, efficiency and straightforward data searching and sharing.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.Data ManagementPharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.