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Tag: EU
EU-GMP: New Annex 16 released
https://seetharamkandarpa.webnode.in/news/eu-gmp-new-annex-16-released/
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/
Variations: Important Changes in the New Application Form
https://seetharamkandarpa.webnode.in/news/variations-important-changes-in-the-new-application-form/
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-/
Who should review Batch Record?
https://seetharamkandarpa.webnode.in/news/who-should-review-batch-record-/
Frequently asked GMP question: How should active substance auditors be qualified?
https://seetharamkandarpa.webnode.in/news/frequently-asked-gmp-question-how-should-active-substance-auditors-be-qualified-/
EU-GMP Guide: final Chapter 2 on Personnel published
https://seetharamkandarpa.webnode.in/news/eu-gmp-guide-final-chapter-2-on-personnel-published/
Black Triangle: a New EU Requirement
https://seetharamkandarpa.webnode.in/news/black-triangle-a-new-eu-requirement/
Overview of the Requirements on WFI in the EU, USA and Japan
https://seetharamkandarpa.webnode.in/news/overview-of-the-requirements-on-wfi-in-the-eu-usa-and-japan/
Revised Annex 16: Comments of the European QP Association
https://seetharamkandarpa.webnode.in/news/revised-annex-16-comments-of-the-european-qp-association/
Risk Assessment for ascertaining GMP for Excipients
https://seetharamkandarpa.webnode.in/news/risk-assessment-for-ascertaining-gmp-for-excipients/
Guidelines on GDP (EU) revised
https://seetharamkandarpa.webnode.in/news/guidelines-on-gdp-eu-revised/
Revision of the EU GMP Guide: EU Commission Publishes Comments for Chapters 3, 5, 6 and 8
https://seetharamkandarpa.webnode.in/news/revision-of-the-eu-gmp-guide-eu-commission-publishes-comments-for-chapters-3-5-6-and-8/
New Developments in the EU with regard to Medical Devices
https://seetharamkandarpa.webnode.in/news/new-developments-in-the-eu-with-regard-to-medical-devices/
Updates on Medical Device Regulations
https://seetharamkandarpa.webnode.in/news/updates-on-medical-device-regulations/
Summary of the new EU GMP Chapters and Annexes
https://seetharamkandarpa.webnode.in/news/summary-of-the-new-eu-gmp-chapters-and-annexes/
Implementation of Good Distribution Practices: Explanatory Notes from MHRA
https://seetharamkandarpa.webnode.in/news/implementation-of-good-distribution-practices-explanatory-notes-from-mhra/
Good Practice Guidelines for Blood Establishments as a Co-Operation between the EDQM/CoE and the EU Commission published
https://seetharamkandarpa.webnode.in/news/good-practice-guidelines-for-blood-establishments-as-a-co-operation-between-the-edqm-coe-and-the-eu-commission-published/
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/
Question & Answer Document on GDP by European Commission
https://seetharamkandarpa.webnode.in/news/question-answer-document-on-gdp-by-european-commission-/
New Rules for Clinical Trials conducted in the EU- Questions & Answers
https://seetharamkandarpa.webnode.in/news/new-rules-for-clinical-trials-conducted-in-the-eu-questions-answers-/
HMPC Q&A Documents on Herbal Medicinal Products
https://seetharamkandarpa.webnode.in/news/hmpc-q-a-documents-on-herbal-medicinal-products/
Guidelines on requirements and expectations for the qualified person in a pharmaceutical company by DHMA
https://seetharamkandarpa.webnode.in/news/guidelines-on-requirements-and-expectations-for-the-qualified-person-in-a-pharmaceutical-company-by-dhma/
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/
Concept paper on the revision of EU GMP Annex 1– manufacture of sterile medicinal products
https://seetharamkandarpa.webnode.in/news/concept-paper-on-the-revision-of-eu-gmp-annex-1-manufacture-of-sterile-medicinal-products/
Final EU GMP Annex 15 Qualification & Validation- Effective from 01 October 2015
https://seetharamkandarpa.webnode.in/news/final-eu-gmp-annex-15-qualification-validation-effective-from-01-october-2015/
New GMP Implementing Act published by EU
https://seetharamkandarpa.webnode.in/news/new-gmp-implementing-act-published-by-eu/
Consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release Testing
https://seetharamkandarpa.webnode.in/news/consultation-on-eu-gmp-guidelines-revised-annex-17-on-the-real-time-release-testing/
Packaging: Pharmeuropa Draft Chapters regarding PVC
https://seetharamkandarpa.webnode.in/news/packaging-pharmeuropa-draft-chapters-regarding-pvc/
GCP - Implementing Regulation on Inspection Procedures
https://seetharamkandarpa.webnode.in/news/gcp-implementing-regulation-on-inspection-procedures/
EMA Q&A on GCP
https://seetharamkandarpa.webnode.in/news/ema-q-a-on-gcp/
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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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