Demonstrating Compliant Final Product Release for a Sterile Parenteral Batch Requires the Use of Quality Control (QC) Instrumentation that Share Certain Common Key Elements
7 May 2017Demonstrating compliant final product release for a sterile parenteral batch requires the use of Quality Control (QC) instrumentation that share certain common key elements. Of course each QC instrument must complete the requirements laid down in the pharmacopoeias or GMP, but in addition each instrument should be optimized to underpin compliance, help reduce human error and maintain data integrity for the test results. This paper describes those common QC instrumentation elements and gives examples of best practice for instruments used for compliant QC batch release.
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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.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.PharmaceuticalsPharmaceuticals 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.