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Tag: API
GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors
https://seetharamkandarpa.webnode.in/news/gmp-audits-of-manufacturers-of-active-substances-minimum-requirements-on-audit-reports-and-qualification-of-auditors/
Guideline on the European Drug Master File Procedure updated
https://seetharamkandarpa.webnode.in/news/guideline-on-the-european-drug-master-file-procedure-updated/
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/
New FDA Guideline on Quality of Heparin
https://seetharamkandarpa.webnode.in/news/new-fda-guideline-on-quality-of-heparin/
Written Confirmation: A Questions & Answer Document of the Danish Authority provides further Clarifications
https://seetharamkandarpa.webnode.in/news/written-confirmation-a-questions-answer-document-of-the-danish-authority-provides-further-clarifications/
CDSCO publishes more than 200 Written Confirmations for APIs from India
https://seetharamkandarpa.webnode.in/news/cdsco-publishes-more-than-200-written-confirmations-for-apis-from-india/
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/
Updated Procedure for the Renewal and Revision of CEPs!
https://seetharamkandarpa.webnode.in/news/updated-procedure-for-the-renewal-and-revision-of-ceps-/
Frequently asked GMP Question: How to reduce testing and comply with GMP?
https://seetharamkandarpa.webnode.in/news/frequently-asked-gmp-question-how-to-reduce-testing-and-comply-with-gmp-/
Black Triangle: a New EU Requirement
https://seetharamkandarpa.webnode.in/news/black-triangle-a-new-eu-requirement/
"Sister File Procedure": New Fast-Track Procedure for the Application of Further CEPs for the Same API
https://seetharamkandarpa.webnode.in/news/sister-file-procedure-new-fast-track-procedure-for-the-application-of-further-ceps-for-the-same-api/
Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files
https://seetharamkandarpa.webnode.in/news/authorisation-of-generic-drugs-in-the-usa-requirements-on-apis-stability-data-for-us-drug-master-files/
European QP Association initiated a database comprising shared audits information
https://seetharamkandarpa.webnode.in/news/european-qp-association-initiated-a-database-comprising-shared-audits-information/
How to submit an Active Substance Master File?
https://seetharamkandarpa.webnode.in/news/how-to-submit-an-active-substance-master-file-/
"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications
https://seetharamkandarpa.webnode.in/news/reception-denied-the-new-fda-refuse-to-receive-guidance-for-generics-applications/
How does the EDQM process CEP Applications? A new Policy provides Information
https://seetharamkandarpa.webnode.in/news/how-does-the-edqm-process-cep-applications-a-new-policy-provides-information/
Final QP Declaration Template by EMA
https://seetharamkandarpa.webnode.in/news/final-qp-declaration-template-by-ema/
Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants by APIC
https://seetharamkandarpa.webnode.in/news/guidance-on-cleaning-validation-in-active-pharmaceutical-ingredients-plants-by-apic/
Delegated Regulation on GMP for APIs published in the Official Journal of the EU
https://seetharamkandarpa.webnode.in/news/delegated-regulation-on-gmp-for-apis-published-in-the-official-journal-of-the-eu/
EU Commission released two final Guidelines on GMP for Excipients and GDP for APIs
https://seetharamkandarpa.webnode.in/news/eu-commission-released-two-final-guidelines-on-gmp-for-excipients-and-gdp-for-apis/
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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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