Traceability for Consumer Safety and Process Improvement’
28 May 2014Traceability is a vital element of product safety in terms of identifying and controlling contamination incidents. Increasing pressure from regulations, such as the U.S. Food & Drug Administration (F.D.A.), Regulations or Bioterrorism Act, force suppliers in several industries to ensure traceability on a one-up/one-down principle, but not dictate the methods.
The companies are free to choose the control methods. Some manufacturers comply using paper-based systems; others may require full networked computer and barcode systems to effectively meet requirements. This paper discusses these requirements and control methods.
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Sample PreparationSample preparation can improve the quality and speed of separation techniques. Products to assist sample preparation include filtration equipment, evaporators, membranes and sieves.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Shipping / PackagingPackaging is the technology of enclosing or protecting products for distribution, storage, sale, and use and the process and production of packages. Packaging is closely linked to Shipping and the preparing of goods for transport, warehousing, logistics, sale, and end use. Within the pharmaceutical industry packaging and shipping are used for transport, storage and logistics between Contract Research Organizations (CROs), Manufacturing and Clinical Trial companies. Packaging is also critical in the final production of a pharmaceutical product before market. 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. 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.Sample Tracking