Q&A

regulatory affairs in pharmaceutical industry role of regulatory affairs in pharmaceutical industry

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regulatory affairs in pharmaceutical industry   importance of regulatory affairs in pharmaceutical industry Regulatory Affairs in Pharmaceuticals: Navigating the Path to Compliance and Success Introduction In today’s highly regulated pharmaceutical industry, compliance with regulatory requirements is crucial for organizations to operate ethically and ensure the safety and efficacy of their products. Regulatory Affairs (RA) plays … Read more

risk assessment in pharma industry

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  risk assessment in pharma industry   which guidelines are used for performing risk assessment in pharmaceutical industry? There are two guidelines which are commonly referred for risk assessment in pharmaceutical industry. 1)ICH Q9 Quality Risk Management Guidelines. 2) WHO guideline published on Devation Handling and Quality Risk Management. which are the three fundamental questions … Read more

sterile water for injections laminar air flow hepa filter

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sterile water for injections laminar air flow hepa filter   What is definition of sterile water for injection as per USP? Sterile water for injection as sterile non-pyrogenic distilled water in a single dose container for intravenous administration after the addition of suitable solute . No antimicrobial substance has been added . pH is 5.5 … Read more

QC questions and answers

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Question & answer for quality control QC questions and answers     What is the purpose of stress testing in stability study? Stress testing of drugs substance can help identify the likely degradation product which can turn help the established degradation pathway and intrinsic stability of the molecule and validate the stability indicating power of … Read more

capa pharmaceutical capa pharmaceutical industry

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capa pharmaceutical capa pharmaceutical industry   why CAPA is considered as important in pharmaceutical industry? Capa are considered as pulse check for FDA on how well-formed quality system is operating. Strong kappa system usually indicates strong quality system of pharmaceutical industry. Which guidelines are referred for kappa in pharmaceutical industry? ICHQ10 guidelines that are referred … Read more

What is deviation & explain threr type

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  What is deviation & explain threr type What is deviation? Deviation is any unwanted event that differ from the approved process procedure instruction specification or established standard . deviation can occur during sampling and testing of drug product,packing & manufacturing. GMP require written procedure for the following   Control of components drug product container … Read more

good documentation practices guidelines good documentation practices in pharma good documentation practices questions and

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good documentation practices good documentation practices ppt good documentation practices guidelines good documentation practices in pharma good documentation practices questions and What is document? A piece of written printed or electronic matter that provides information or evidence or proof of any activity that serves as an official record. Why document are required in pharmaceutical? For … Read more

importance of validation in pharma industry

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importance of validation in pharma industry importance of validation in pharma industry pdf importance of validation in pharma industry ppt   Validation is a concept that has been developed gradually seen its first formal apparency United state in 1978 . concept of validation was first proposed by two FDA official ted byers and bird loftus … Read more

HPLC questions & answer.

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HPLC questions & answer. HPLC-full-form high-performance liquid chromatogrphy what is the chromatography? Chromatography may be regarded as an analytical technique used for the purifications, identifications, and separations of the organic and inorganic compound. principles of HPLC? distributions of analyte between stationary phase and mobile phase according to its distributions coefficient. type of chromatography according to … Read more

Question and answer of Quality assurance department 

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Question and answer of Quality assurance department   Define quality assurance? quality insurance is a broad range of concept contains all the matters that individually or collectively effect the quality of a product. QA mainly concentrated on planning & documenting the procedure to assure quality of the product. What is the responsibility of quality assurance? … Read more

What is compression machine & definitions of tablet

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What is compression machine & definitions of tablet What is compression machine? The compression machine is used to manufacture tablet by compressing the granules powder in the solid doses form. Compression machine is used to manufacture tablet manufacturing from the granules or powder and solid doses form by compressing. What is the part of compression … Read more

degassing of mobile phase in hplc degassing of mobile phase can be done by

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degassing of mobile phase in hplc degassing of mobile phase can be done by   degassing of HPC mobile phase plays a very important role in HPLC analysis. what is degassing? Degassing is a technique in which removal of dissolved air or air bubbles from the solvent mixture or mobile phase.   why degassing of … Read more