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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-/
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 GMP Guide regarding the Principles of GMP
https://seetharamkandarpa.webnode.in/news/who-revises-gmp-guide-regarding-the-principles-of-gmp/
FDA publishes Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
https://seetharamkandarpa.webnode.in/news/fda-publishes-guidance-for-industry-blood-establishment-computer-system-validation-in-the-users-facility/
FDA Guide on Import of Drugs prior to approval
https://seetharamkandarpa.webnode.in/news/fda-guide-on-import-of-drugs-prior-to-approval/
New FDA Requirements on Labelling and Container Labels
https://seetharamkandarpa.webnode.in/news/new-fda-requirements-on-labelling-and-container-labels/
New FDA Requirement on the Handling of INDs
https://seetharamkandarpa.webnode.in/news/new-fda-requirement-on-the-handling-of-inds/
FDA publishes current list of Drug Master Files (Type II)
https://seetharamkandarpa.webnode.in/news/fda-publishes-current-list-of-drug-master-files-type-ii-/
FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics
https://seetharamkandarpa.webnode.in/news/fda-publishes-revised-guidance-for-applicants-of-marketing-authorisations-for-generics/
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/
EMA published Concept Paper on the Revision of the Finished Dosage Form Guideline
https://seetharamkandarpa.webnode.in/news/ema-published-concept-paper-on-the-revision-of-the-finished-dosage-form-guideline/
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/
"SRK GMP OCEAN"- My Mobile Application Works for Android & HTML5
https://seetharamkandarpa.webnode.in/news/srk-gmp-ocean-my-android-application/
New EU GMP Guide Chapter 6
https://seetharamkandarpa.webnode.in/news/new-eu-gmp-guide-chapter-6/
Overview of new CDRH Guidelines
https://seetharamkandarpa.webnode.in/news/overview-of-new-cdrh-guidelines/
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/
CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports: new FDA Guidance
https://seetharamkandarpa.webnode.in/news/cmc-postapproval-manufacturing-changes-to-be-documented-in-annual-reports-new-fda-guidance/
Draft on Process Validation by WHO
https://seetharamkandarpa.webnode.in/news/draft-on-process-validation-by-who/
PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP)
https://seetharamkandarpa.webnode.in/news/pic-s-committee-has-adopted-a-guide-on-good-distribution-practice-gdp-/
FDA Issues Final Guidance on "Considerations When Transferring Clinical Investigation Oversight to Another IRB"
https://seetharamkandarpa.webnode.in/news/fda-issues-final-guidance-on-considerations-when-transferring-clinical-investigation-oversight-to-another-irb/
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/
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/
New Guidance on Environmental Assessments for Biotechnology Products by USFDA
https://seetharamkandarpa.webnode.in/news/new-guidance-on-environmental-assessments-for-biotechnology-products-by-usfda/
USFDA Guidance on "ANDA Submissions- Refuse-to-Receive Standards" Effective from 26 May 2015
https://seetharamkandarpa.webnode.in/news/usfda-guidance-on-anda-submissions-refuse-to-receive-standards-effective-from-26-may-2015/
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/
New final Guidance from USFDA related to Pharmaceutical Quality/CMC on 'Analytical Procedures and Methods Validation for Drugs and Biologics
https://seetharamkandarpa.webnode.in/news/new-final-guidance-from-usfda-related-to-pharmaceutical-quality-cmc-on-analytical-procedures-and-methods-validation-for-drugs-and-biologics/
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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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