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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New Draft Guidance - Cosmetic Good Manufacturing Practices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/
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About Me
SEETHARAM KANDARPA
Seetharam Kandarpa Receives ASQ-Certified Manager of Quality/Organizational Excellence
Web Series 2 of ASQ CQA Mentoring Class: Auditing Fundamentals on 30 July 2017
Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)
Web Series Session 1: Overview of ASQ Certified Quality Auditor conducted on 21 May 2017
Register to Join Mentoring Class for ASQ-CQA
Mentoring Class for ASQ-CQA
G.ONE (GMP-ONE)- One Spot for all GMP Links required in our JEEVAN
Seetharam Kandarpa Receives ASQ Quality Auditor
Seetharam Kandarpa Receives ASQ-Certified Pharmaceutical GMP Professional
ISO 9001: 2008 Quality Management Systems – Requirements
My new Mobile Application "SRK GCP World"
MACO Calculation Sheet in Cleaning Validation
My new Mobile Application "SRK GMP Videos"
"SRK CLEANING VALIDATION"- My new mobile application
"SRK GMP OCEAN"- My Mobile Application Works for Android & HTML5
"SRK GMP FAQ"- My new Mobile Application
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