Quality Control

What is an Active Pharmaceutical Ingredient?

Quality Control

What is an Active Pharmaceutical Ingredient? “active pharmaceutical ingredient (API) Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological […]

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GMP Requirements for Certificates of Analysis (CoA)

Quality Control

GMP Requirements for Certificates of Analysis (CoA) At times of outsourcing and globalisation, the significance of Certificates of Analysis (CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy and completeness. There are CoAs for excipients, APIs, packaging materials and finished products. A closer look at the guidelines shows that there are

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General Safety Rules for  Quality Control Laboratory. 

Quality Control

General Safety Rules for  Quality Control Laboratory. General Safety Rules For Quality Control Laboratory. General and specific safety instructions reflecting identified risk, should be made available to each staff member and supplemented regularly as appropriate (e.g. with written material, poster displays, audiovisual material and occasional seminars). General rules for safe working in accordance with national

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Most Common Interview Questions For Quality Assurance & Quality Control Department.

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  Before attending any QA&QC interviews be prepared for the below question – Answer QA&QC DEPARTMENT List of all questions asked in interviews of quality control and quality assurance 1 Can any deviation be changed into the change control? 2 What is the difference between Humidity and Relative Humidity? 3 What should be the temperature

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Most Common Interview Questions For Regulatory Affairs Department.

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Most Common Interview Questions For Regulatory Affairs Department.   1.What is Regulatory Affairs? Ans-Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their

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How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification(OOS).   What USFDA guideline says about Investigation of Out

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What is Data Integrity In Pharmaceutical Industry…???

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What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working,

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