Abha Maurya

Quality Metrics in pharmaceutical industry

Quality Metrics in pharmaceutical industry Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. Quality Metrics play an important role in the desired state of pharmaceutical quality and regulation – minimal but effective regulatory oversight that …

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USFDA 483 Warning Letter Dated MARCH 30, 2022

USFDA 483 Warning Letter Dated MARCH 30, 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, …

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Reference-Standard and Working Standards

Reference-Standard and Working Standards The US Food and Drug Administration defines a reference-standard material as a “highly purified compound that is well characterized” (1). The US Pharmacopeia (USP) defines reference-standard materials as “highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators” (2). Scientists …

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REMEDIATION OF DATA INTEGRITY FAILURES

REMEDIATION OF DATA INTEGRITY FAILURES Responding to Significant Data Integrity issues Consideration should be primarily given to resolving the immediate issues identified and assessing the risks associated with the data integrity issues. The response by the company in question should outline the actions taken as part of a remediation plan. …

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Classification of data integrity deficiencies

Classification of data integrity deficiencies To aid consistency in reporting and classification of data integrity deficiencies Deficiencies relating to data integrity failure may have varying impact to product quality. Prevalence of the failure may also vary between the actions of a single employee to an endemic failure throughout the inspected …

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Bung Processor / Autoclave

Bung Processor / Autoclave Definition of Autoclave An autoclave is a pressure chamber used to carry out industrial processes requiring elevated temperature and pressure different to ambient air pressure. Autoclave is used in medical application to perform sterilization, and in the chemical industry to cure coatings, vulcanise rubber and for …

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TURN TABLE

TURN TABLE Turntables are horizontal, rotatable powered table mechanisms for transferring material/container between conveyors that are in angular relation to one another.  They often provide both loading and unloading of their contents to and from a conveyor.  In order to increase productivity and ergonomics in any manufacturing operation, equipment such …

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HPLC Interview Questions

HPLC Interview Questions Question 1: What is Full form of HPLC? Answer: HPLC stands for High-performance Liquid Chromatography or High-pressure Liquid Chromatography. Question 2: What is HPLC Principle? or What is Principle of Chromatography? Answer: It is a chromatographic technique used to separate the components from a mixture of a …

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