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所在平台: Udemy |
课程主页: https://www.udemy.com/course/complete-ipqc-tests-for-pharmaceutical-tablet-dosage-form/
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课程名称：制药片剂形式的完整过程质量控制（IPQC）测试 概述：本课程旨在教授制药片剂在开发阶段的质量评估方法。在产品设计和组装过程中，建立必要的物理、化学和生物参数，确保符合质量要求至关重要。生产过程中，进行过程质量控制（IPQC）测试对最终产品的质量保障至关重要。这些测试贯穿整个制造过程，可以监测和调整操作，以确保产品符合规范，最终产生高质量的片剂。IPQC的主要目标是在每个生产阶段防止或纠正错误，从而获得完美的成品。 在制造过程结束后，按药典规定对成品进行质量控制测试（FPQC），以评估质量参数是否在可接受范围内。课程将提供按照药典指南的制药片剂IPQC和FPQC测试知识。拒绝的不合格过程材料需在隔离系统下识别和控制，以防其在制造中被使用。 课程中的主要内容包括： - IPQC的定义及其重要性 - 制药片剂的物理参数监控，包括大小、形状、颜色和气味、厚度、重量变化测试、硬度测试、脆性测试及崩解测试 - 质量控制设备的使用，如脆性仪、崩解仪、硬度测试仪和游标卡尺 课程适合： - 大专药学学生 - 本科药学学生 - 硕士药学学生 - 制药行业从业人员 - 制药专业人士 课程收益： - 学习过程质量控制（IPQC）测试方法 - 片剂剂型的质量控制 - 设备的理论与实践演示 - 完成后颁发证书 此课程为制药行业人员提供了宝贵的专业知识，帮助其提升药物制造过程中的质量控制能力。
The assessment of tablet quality must be undertaken during the development phase of the product. During the product's design and assembly, it is imperative to establish the physical, chemical, and biological parameters necessary to ensure compliance with quality requirements and the setting of quality objectives. The utilization of in-process quality control (IPQC) testing is crucial during production to guarantee the quality of the final product. These tests, conducted throughout the manufacturing process, enable the monitoring and adjustment of operations to ensure that the product aligns with specifications, ultimately resulting in tablets of excellent quality. The main aim of IPQC is to prevent or rectify errors at each stage of production, thus yielding an impeccable finished product. Once the manufacturing process concludes, finished product quality control (FPQC) tests, in accordance with the specifications outlined in the pharmacopoeia, are performed on the pharmaceutical tablets. Such tests are instrumental in assessing whether the quality parameters fall within acceptable limits. The purpose of this study is to provide IPQC and FPQC testing for pharmaceutical tablets in accordance with the pharmacopoeia guidelines.Rejected in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturingDEFINITION OF IPQC IPQC stands for IN PROCESS QUALITY CONTROL. These are checks that are carried out before the manufacturing process is completed. The function of of in-process controls is monitoring and if necessary adaption of the manufacturing process in order to comply with the specifications.this may include control of equipment and environment too. In-process materials should be tested for identity, strength, quality and purity as appropriate and approved or rejected by the quality control unit during the production process. Rejected in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing.Written procedure should be established and followed that describe the in-process controls and tests as specifiedIPQC testing of pharmaceutical tablets was regulates by various physical parameters:Size and Shape: The tablet's size and configuration can be monitor and managed, an attribute verified by the device during the compression process. Color and Odor: Many industries use color as an important method for quick identification and customer acceptance. But, this should be the same on the same floor, from floor to floor, from place to place. An odor coming from the medication stack may indicate an ongoing problem. E.g; Dissolved aspirin tablets produce an acetic acid odor characteristic of the drug. Vitamins have a unique smell. Taste is important to consumer acceptance of chewable tablets. Thickness: The performance of the tablet is exclusively influenced by its thickness, which can be evaluated by observing the dimensions of its various layers through a microscope. An alternative approach involves incorporating 5 or 10 layers into the seating and potentially utilizing a sliding scale to ascertain the overall thickness. Weight Variation Test: The USP weight change test is an analytical procedure in which 20 tablets are weighed individually to determine the average weight. The weight of each pill is compared to the average weight. The results of the weight change test are presented as percentages.Hardness Test: A quick testing tool, the Ketane tablet hardness tester is used to assess tablet hardness, especially when using a variation of the Monsanto hardness tester. The device consists of a cylindrical container containing a compression spring placed between two pistons. When the bottom piston hits the ground, the first measurement is taken. The threaded bolt is pressed against the upper piston, causing the plate to break. As the spring is compressed, the pointer moves on a calibrated scale inside the container to show the force of application. The force required to break is expressed in kilograms. Friability Test: Laboratory analysis of tablet friability requires the use of Roche friabilator. Take 20 tablets and put them in the machine, applying a rotation speed of 25 rpm for 4 minutes. The tablets are compressed and weighed again. The difference between the initial and final stresses is used to determine a percentage value that represents friability.Disintegration Test: This test refers to check the time required for tablet disintegration.QUALITY CONTROL EQUIPMENTSFriabilatorDisintegration apparatusHardness TesterVernier CaliperCourse Eligibility:Diploma Pharmacy StudentsBachelor of Pharmacy StudentsMaster of pharmacy StudentsPharmaceutical industryPharma ProfessionalsBenefits of course:Learning of IPQC TestsTablet Dosage quality controlHadling of Equipments Theory & Practical demonstrationCertificate of completion
