Tag: draft

FDA Two new Q&As published for Investigational Drugs

https://seetharamkandarpa.webnode.in/news/fda-two-new-q-as-published-for-investigational-drugs/

Canada: GMP Requirements now Applicable to all APIs

https://seetharamkandarpa.webnode.in/news/canada-gmp-requirements-now-applicable-to-all-apis/

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/

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/

FDA Releases Guidance on Quality Agreements for Contract Manufacturing

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

New Draft Guidance - Cosmetic Good Manufacturing Practices

https://seetharamkandarpa.webnode.in/news/new-draft-guidance-cosmetic-good-manufacturing-practices/

New FDA Guidance on the Finalization of several FDA Draft Guidances

https://seetharamkandarpa.webnode.in/news/new-fda-guidance-on-the-finalization-of-several-fda-draft-guidances/

WHO revises Guideline for Maximum Hold Times

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

WHO revises GMP Guide regarding the Principles of GMP

https://seetharamkandarpa.webnode.in/news/who-revises-gmp-guide-regarding-the-principles-of-gmp/

USP Draft of a newly proposed Chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products

https://seetharamkandarpa.webnode.in/news/usp-draft-of-a-newly-proposed-chapter-1115-bioburden-control-of-nonsterile-drug-substances-and-products/

Revision of USP Chapter on IR Spectroscopy

https://seetharamkandarpa.webnode.in/news/revision-of-usp-chapter-on-ir-spectroscopy/

FDA published Guideline Draft on the Registration of Production Sites

https://seetharamkandarpa.webnode.in/news/fda-published-guideline-draft-on-the-registration-of-production-sites/

WHO publishes revised draft on GTDP for pharmaceutical starting material

https://seetharamkandarpa.webnode.in/news/who-publishes-revised-draft-on-gtdp-for-pharmaceutical-starting-material/

ASEAN Countries published Draft of a Guideline on Process Validation

https://seetharamkandarpa.webnode.in/news/asean-countries-published-draft-of-a-guideline-on-process-validation/

USFDA Draft Guidance - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection

https://seetharamkandarpa.webnode.in/news/usfda-draft-guidance-circumstances-that-constitute-delaying-denying-limiting-or-refusing-a-drug-inspection/

Revised Annex 16: Comments of the European QP Association

https://seetharamkandarpa.webnode.in/news/revised-annex-16-comments-of-the-european-qp-association/

Draft EU GMP Annex 15 for Qualification and Validation published

https://seetharamkandarpa.webnode.in/news/draft-eu-gmp-annex-15-for-qualification-and-validation-published/

New FDA Guidance to Avoid Overfill of Vials

https://seetharamkandarpa.webnode.in/news/new-fda-guidance-to-avoid-overfill-of-vials/

WHO published revised draft on the Guideline on "Hold Time" studies

https://seetharamkandarpa.webnode.in/news/who-published-revised-draft-on-the-guideline-on-hold-time-studies/

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/

Organic Impurities Testing: USP plans extensive Revision of General Chapters and Monographs

https://seetharamkandarpa.webnode.in/news/organic-impurities-testing-usp-plans-extensive-revision-of-general-chapters-and-monographs/

Draft on Process Validation by WHO

https://seetharamkandarpa.webnode.in/news/draft-on-process-validation-by-who/

USFDA Draft Guidance on "Conditions: Reportable CMC Changes for Approved Drug and Biologic Products" Effective from 29 May 2015

https://seetharamkandarpa.webnode.in/news/usfda-draft-guidance-on-conditions-reportable-cmc-changes-for-approved-drug-and-biologic-products-effective-from-29-may-2015/

WHO Draft on 'SUPPLEMENTARY GUIDELINES ON GMP FOR HVAC SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS'

https://seetharamkandarpa.webnode.in/news/who-draft-on-supplementary-guidelines-on-gmp-for-hvac-systems-for-non-sterile-pharmaceutical-dosage-forms/