Your Queries: 1. Media Fill Failure Investigation 2. Media failure 3. Aseptic filling 4. Investigation 5. How to investigate media Fill Failure 6. Aseptic process simulation 7. Laminar Air Flow 8. Aseptic filling failure                   Pl…

This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities    Please …

Lets discuss about analytical instrument qualification.    Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube Button Video        Watch More Videos Click Here

Analytical Balance are highly sensitive lab instruments designed to accurately measure mass. Their readability has a range between 0.1mg - 0.01mg. There should be compliance in minimum requirements of current regulatory. A short overvi…

Data management refers to all those activities performed during the handling of data including but not limited to data policy, documentation, quality and security. Good data management practices influence the quality of all data generat…

ICH Quality Guideline                                         Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube Button Video        Watch More Videos Click Here

Computer system Validation (Basics) are related to current regulatory requirement for use of Computer in GXP environment.                                         Please Subscribe my You tube Channel   Watch Full Section Click Link and You…

Regulatory Agencies, like the FDA and EudraLex require companies to audit software vendors of their critical software and systems. Regulated companies include several industries – Pharmaceuticals, Biologics, Medical Devices, Clinical Studi…

we are here to discuss about the current regulatory requirement in pharmaceutical industry                                                                        Please Subscribe my You tube Channel   Watch Full Section Click Link and You …

This vedio is related to describe the Food and Drug Administration's (FDA’s) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 C…

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Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have…

Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have …

This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities                              …

How to Qualify Analytical Instrument, Different Qualification approch.                                                                        Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube Button Video        …

Data integrity refers to the accuracy, completeness and consistency of GxP data over its entire lifecycle. The steps that need to be overseen include the initial generation and recording, the processing (incl. analysis, transformatio…