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Showing posts with the label GMPShow all
FDA 21 CFR Part 11 Guidelines for Pharmaceuticals

FDA 21 CFR Part 11 Guidelines for Pharmaceuticals November 18, 2022

What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products?

What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? November 14, 2022

GMP Knowledge Quiz Test One

GMP Knowledge Quiz Test One November 07, 2022

Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution?

Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution? November 04, 2022

FDA Process Validation Guidance 2011: General Principles and Practices

FDA Process Validation Guidance 2011: General Principles and Practices November 04, 2022

Should acceptance criteria for residues be defined for dedicated equipment?

Should acceptance criteria for residues be defined for dedicated equipment? October 31, 2022

Does ICH Q7 expect that the quality unit performs API release testing?

Does ICH Q7 expect that the quality unit performs API release testing? October 21, 2022

Who must register and submit medical device list to FDA?

Who must register and submit medical device list to FDA? October 17, 2022

Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. Is this okay?

Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. Is this okay? October 10, 2022

IGMPI Notice for Admissions in Various PG Diploma & Professional Certifications

IGMPI Notice for Admissions in Various PG Diploma & Professional Certifications September 09, 2022

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ICH Quality Guidelines Q1 to Q14 for Pharmaceuticals

ICH Quality Guidelines Q1 to Q14 for PharmaceuticalsNovember 24, 2020

ICH Q1A - Q1F Stability Guidelines

ICH Q1A - Q1F Stability GuidelinesNovember 24, 2020

ICH Q7 GMP Guidelines For API in Telugu

ICH Q7 GMP Guidelines For API in TeluguMay 22, 2020

ICH Q2 Analytical Validation Guidelines

ICH Q2 Analytical Validation GuidelinesNovember 24, 2020

ICH S12 Non-clinical Biodistribution Studies for Gene Therapy

ICH S12 Non-clinical Biodistribution Studies for Gene TherapyDecember 07, 2020

WHO TRS 986, 2014 Annex 2

WHO TRS 986, 2014 Annex 2August 25, 2020

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