GMP Guidlines
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Posted: December 13, 2023Pre-Approval Inspections (PAIs) are crucial regulatory assessments conducted by pharmaceutical regulatory bodies to…Continue Read
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Posted: December 13, 2023GMP equipment logbooks are essential for ensuring the quality and safety of pharmaceutical products throughout the…Continue Read
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Posted: March 08, 2019What is GMP - Good Manufacturing Practice ?We all know that microorganisms –…Continue Read
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Posted: March 08, 2019As a manufacturer bringing pharmaceutical product to the US market your company is always in the vigilant eyes of…Continue Read
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Posted: March 08, 2019Manufacturing of drugs is very often a complex process – employees keep changing, efficiency of machines…Continue Read
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Posted: March 08, 2019The Quality Assurance department is accountable that products being distributed for consumption are of good…Continue Read
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Posted: March 08, 2019FDA Inspection of Clinical Investigators Before a medicine is launched into market, it undergoes clinical trials to…Continue Read
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Posted: March 08, 2019What Does the Revised FDA Process Validation mean to youThere has been several…Continue Read
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Posted: March 08, 2019GMP Failure Investigation: Identifying and Fixing the Root Cause The Code of Federal…Continue Read
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Posted: March 08, 2019The term Out-of-specification is used so often in pharmaceutical industry, but many of us are still unaware of…Continue Read
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Posted: March 08, 2019Preparing for Pre-approval Inspection Pre-approval inspection is a critical requirement…Continue Read
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Posted: March 08, 2019Conducting a GMP Supplier Audit In order to reduce the cost, pharmaceutical companies…Continue Read
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Posted: March 08, 2019Composing a GMP Technical Agreement In today’s competitive environment, pharmaceutical…Continue Read
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Posted: March 08, 2019GMP validation is an element of quality assurance program for a pharmaceutical/biotech product or process. To…Continue Read
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Posted: March 08, 2019What is a GMP Warning Letter, Anyway? The regulatory bodies – FDA and European…Continue Read
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Posted: March 07, 2019Overview about one of the most important and biggerst Health Agencies in the world. The FDA - The Food…Continue Read
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Posted: March 07, 2019The management of each operational site is required to define responsibility for origination, distribution, maintenance, change control, and…Continue Read
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Posted: March 07, 2019How to Sustain GMP Compliance in Your Pharmaceutical Company The pharmaceutical industry in every country is heavily…Continue Read