Achieving Compliant Batch Release – Sterile Parenteral Quality Control
22 Nov 2018Demonstrating 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. 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. Ultrapure WaterUltrapure water is the highest purity water and contains the lowest levels of organic and inorganic contaminants, particulates and microorganisms.Pure WaterPure water is processed to remove significant level of contaminants and is suitable for use in many laboratory applications.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.