Tag: guideline

WHO Guideline on Quality Risk Management finalised

https://seetharamkandarpa.webnode.in/news/who-guideline-on-quality-risk-management-finalised/

Guideline on the European Drug Master File Procedure updated

https://seetharamkandarpa.webnode.in/news/guideline-on-the-european-drug-master-file-procedure-updated/

Final EMA Variations Guideline on Procedures Issues and Classification of Variations published

https://seetharamkandarpa.webnode.in/news/final-ema-variations-guideline-on-procedures-issues-and-classification-of-variations-published/

WHO publishes Variations Guideline for Prequalified APIs and Medicinal Products

https://seetharamkandarpa.webnode.in/news/who-publishes-variations-guideline-for-prequalified-apis-and-medicinal-products/

Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

https://seetharamkandarpa.webnode.in/news/biological-products-human-blood-and-blood-components-intended-for-transfusion-or-for-further-manufacture/

New FDA Guideline on Quality of Heparin

https://seetharamkandarpa.webnode.in/news/new-fda-guideline-on-quality-of-heparin/

New EMA Inspection Requirements on Good Distribution Practices (GDP)

https://seetharamkandarpa.webnode.in/news/new-ema-inspection-requirements-on-good-distribution-practices-gdp-/

New Requirements of the FDA on Stability Testing of Generic Drugs

https://seetharamkandarpa.webnode.in/news/new-requirements-of-the-fda-on-stability-testing-of-generic-drugs/

Denying, Delaying, And Refusing: How to Fail a FDA Inspection

https://seetharamkandarpa.webnode.in/news/denying-delaying-and-refusing-how-to-fail-a-fda-inspection/

Draft Guideline ICH Q3D for Elemental Impurities published!

https://seetharamkandarpa.webnode.in/news/draft-guideline-ich-q3d-for-elemental-impurities-published-/

New EMA Guideline on Starting Materials from Biological Medicinal Products

https://seetharamkandarpa.webnode.in/news/new-ema-guideline-on-starting-materials-from-biological-medicinal-products/

Updated Procedure for the Renewal and Revision of CEPs!

https://seetharamkandarpa.webnode.in/news/updated-procedure-for-the-renewal-and-revision-of-ceps-/

PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US

https://seetharamkandarpa.webnode.in/news/plair-new-fda-guideline-regulates-import-of-non-approved-drugs-in-the-run-up-to-the-launch-in-us/

FDA Releases Guidance on Quality Agreements for Contract Manufacturing

https://seetharamkandarpa.webnode.in/news/fda-releases-guidance-on-quality-agreements-for-contract-manufacturing/

FDA issues Guidance for Industry on Risk-Based Monitoring

https://seetharamkandarpa.webnode.in/news/fda-issues-guidance-for-industry-on-risk-based-monitoring/

EFPIA - What Medicinal Product Manufacturers need to know about the European Verification System EMVS

https://seetharamkandarpa.webnode.in/news/efpia-what-medicinal-product-manufacturers-need-to-know-about-the-european-verification-system-emvs/

WHO revises Guideline for Maximum Hold Times

https://seetharamkandarpa.webnode.in/news/who-revises-guideline-for-maximum-hold-times/

Interesting APIC/CEFIC Guideline for the Qualification of Contract Laboratories

https://seetharamkandarpa.webnode.in/news/interesting-apic-cefic-guideline-for-the-qualification-of-contract-laboratories/

EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products

https://seetharamkandarpa.webnode.in/news/ema-guideline-on-the-use-of-bovine-serum-in-the-manufacture-of-human-biological-medicinal-products/

FDA Publishes Guidance on Clinical Trials

https://seetharamkandarpa.webnode.in/news/fda-publishes-guidance-on-clinical-trials/

Successor Organisation (IMDRF) of the GHTF

https://seetharamkandarpa.webnode.in/news/successor-organisation-imdrf-of-the-ghtf/

New FDA Guidelines for Medical Devices

https://seetharamkandarpa.webnode.in/news/new-fda-guidelines-for-medical-devices/

EMA publishes Guideline on Pharmaceutical Development of Medicines for Paediatric Use

https://seetharamkandarpa.webnode.in/news/ema-publishes-guideline-on-pharmaceutical-development-of-medicines-for-paediatric-use/

EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

https://seetharamkandarpa.webnode.in/news/ema-guideline-on-quality-of-biological-active-substances-produced-by-transgene-expression-in-animals/

"SRK GMP OCEAN"- My Mobile Application Works for Android & HTML5

https://seetharamkandarpa.webnode.in/news/srk-gmp-ocean-my-android-application/

GMP for Radiopharmaceuticals - existing and expected Guidelines

https://seetharamkandarpa.webnode.in/news/gmp-for-radiopharmaceuticals-existing-and-expected-guidelines/

New EMA Guideline on Stability Testing for Applications for Variations

https://seetharamkandarpa.webnode.in/news/new-ema-guideline-on-stability-testing-for-applications-for-variations/

Draft Guideline on Validation of biotechnology-derived Products by EMA

https://seetharamkandarpa.webnode.in/news/draft-guideline-on-validation-of-biotechnology-derived-products-by-ema/

Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) [EudraLex - Volume 2]

https://seetharamkandarpa.webnode.in/news/update-of-guideline-on-the-packaging-information-of-medicinal-products-for-human-use-authorised-by-the-union-july-2015-eudralex-volume-2/

EMA revises Guide on Pharmaceutical Water

https://seetharamkandarpa.webnode.in/news/ema-revises-guide-on-pharmaceutical-water/