Tag: Guide

Frequently asked GMP Question: How to reduce testing and comply with GMP?

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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/