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Microbial contamination of parenteral product is one among the foremost serious problems presently facing the pharmaceutical trade. Injectable drugs that are administered directly into the circulatory system bypass variety of innate human immune defenses related to the system. Therefore, to confirm the sterility of every of those products before patient administration, pharmaceutical corporations should adhere to strict government rules concerning quality control.
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Scope and Importance:
Quality control shall be concerned with sampling,Specifications, Testing, documentation, Release procedure which ensure that necessary and relevant tests are actually carried out and materials are not release for its use or For sale, until its quality has been judged to satisfactory. The 3 General areas of parenteral quality control are incoming stocks, manufacturing and Finished products. The Basic quality control tests which are performed on sterile parenteral products include :-
The Clinical and Laboratory Standards Institute (CLSI) encourages the use of third party controls. The Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline – Third Edition states that “Quality control materials should be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of the measurement procedure’s performance in its entirety, including the procedure for calibration of the measurement.”
The global market for contract pharmaceutical manufacturing, research and packaging totaled $248.5 billion in 2014 and is projected to approach $352.8 billion by 2019, registering a compound annual growth rate (CAGR) of 7.3% through 2019.
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This page was last updated on 11th Sep, 2015
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