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Category: Download

BATCH RECORD REVIEW/ RELEASE BY EXCEPTION – PDF Download
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BATCH RECORD REVIEW/ RELEASE BY EXCEPTION – PDF Download

Posted on May 29, 2018 by admin

http://www.manostaxx.com Batch Record Requirements EU Chapter 4.20 A Batch Processing Record should be kept for each batch processed. It should be based on the relevant…

PHARMACEUTICAL BATCH MANUFACTURING RECORD – Sample Download
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PHARMACEUTICAL BATCH MANUFACTURING RECORD – Sample Download

Posted on May 29, 2018November 19, 2018 by admin

http://www.manostaxx.com   Download PDF here Continue at:  http://asean.org/storage/2012/10/ASEAN-TMHS-GMP-Training-Chapter-5-Annex-5-Sample-Batch-Manufacturing-Record.pdf The text above is owned by the site above referred. Here is only a small part of the…

Sample of Batch Manufacturing Record (BMR) – Atorvastatin – PDF Download
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Sample of Batch Manufacturing Record (BMR) – Atorvastatin – PDF Download

Posted on May 29, 2018 by admin

http://www.manostaxx.com   SOURCE: http://www.pharmaguideline.com/2015/05/batch-manufacturing-record-bmr.html The text that follows is owned by the site above referred. Here is only a small part of the article, for…

Guidelines for Dietary Supplements and Botanicals – PDF Download
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Guidelines for Dietary Supplements and Botanicals – PDF Download

Posted on May 16, 2018 by admin

http://www.manostaxx.com Because of the time and expense required for the determination of modern analytes such as pesticide residues, industrial contaminants, veterinary drugs, allergens, botanicals, dietary supplements, and alternative…

Safety Management Manual (SMM) – PDF download
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Safety Management Manual (SMM) – PDF download

Posted on May 16, 2018 by admin

http://www.manostaxx.com This manual is intended to provide States with guidance for the development and implementation of a State safety programme (SSP), in accordance with the…

SeDeM ODT Expert System in FormulationDevelopment of Orodispersible Tablets – PDF Download
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SeDeM ODT Expert System in FormulationDevelopment of Orodispersible Tablets – PDF Download

Posted on May 16, 2018 by admin

http://www.manostaxx.com Background: Rosuvastatin calcium exhibits poor oral bioavailability due to extensive pre-systemic metabolism. Orodispersible tablets (ODTs) were prepared that disintegrate rapidly in oral mucosa thus preventing pre- systemic…

Computer System Validation Template – Word File Download
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Computer System Validation Template – Word File Download

Posted on May 14, 2018 by admin

http://www.manostaxx.com This is an example of a Master Plan. It is a proposal and starting point only. The type and extent of documentation depends on…

VALIDATION SUMMARY REPORT FOR THE EXAMPLE VALIDATION SPREADSHEET – PDF Download
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VALIDATION SUMMARY REPORT FOR THE EXAMPLE VALIDATION SPREADSHEET – PDF Download

Posted on May 14, 2018 by admin

http://www.manostaxx.com This Final Summary Reports summarizes the results obtained during the execution of the Installation/Operational (IOQ) Qualification (IOQ-001), for the validation of the Example Validation…

10 Steps to Software Validation – PDF Download
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10 Steps to Software Validation – PDF Download

Posted on May 13, 2018 by admin

http://www.manostaxx.com Software validation confirms that certain specifications coincide with user needs, the software is meeting intended use and requires objective evidence that the requirements can be…

Application of Continued Process Verification (CPV) to New Products – PDF download
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Application of Continued Process Verification (CPV) to New Products – PDF download

Posted on May 13, 2018 by admin

http://www.manostaxx.com Validation in General Planning and Knowledge are EVERYTHING  Documenting the established approaches and terms, process monitoring, testing methods, acceptance criteria, etc. prior to…

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