Tag: GMP

Comparison of EU GMP and Indian GMP Requirements for APIs

https://seetharamkandarpa.webnode.in/news/comparison-of-eu-gmp-and-indian-gmp-requirements-for-apis/

Written Confirmations: Questions & Answers Document Version 4.1 published!

https://seetharamkandarpa.webnode.in/news/written-confirmations-questions-answers-document-version-4-1-published-/

Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 - Quality Control

https://seetharamkandarpa.webnode.in/news/revision-of-the-eu-gmp-guide-eu-commission-proposal-for-chapter-6-quality-control/

Brazil's GMP Guideline Available in English

https://seetharamkandarpa.webnode.in/news/brazils-gmp-guideline-available-in-english/

Written Confirmation: Australia gets on the List of "Third Countries"

https://seetharamkandarpa.webnode.in/news/written-confirmation-australia-gets-on-the-list-of-third-countries/

Handling of APIs and Excipients - New Guidelines in Chapter 5 of EU GMP Guide

https://seetharamkandarpa.webnode.in/news/handling-of-apis-and-excipients-new-guidelines-in-chapter-5-of-eu-gmp-guide/

EMA issues Draft Guideline on Similar Biological Medicinal Products for public consultation

https://seetharamkandarpa.webnode.in/news/ema-issues-draft-guideline-on-similar-biological-medicinal-products-for-public-consultation/

Ranbaxy pleads guilty and pays $500 million fine

https://seetharamkandarpa.webnode.in/news/ranbaxy-pleads-guilty-and-pays-500-million-fine-/

FDA addresses retention of Internal Audit Reports

https://seetharamkandarpa.webnode.in/news/fda-addresses-retention-of-internal-audit-reports/

MHRA CONCLUSION on New requirements for active substances imported into the European Economic Area

https://seetharamkandarpa.webnode.in/news/mhra-conclusion-on-new-requirements-for-active-substances-imported-into-the-european-economic-area/

Canada: GMP Requirements now Applicable to all APIs

https://seetharamkandarpa.webnode.in/news/canada-gmp-requirements-now-applicable-to-all-apis/

Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5

https://seetharamkandarpa.webnode.in/news/half-year-report-2013-fda-medical-devices-warning-letter-statistics-2-new-deficiency-group-in-the-top-5/

Incredible and Alarming GMP Violations

https://seetharamkandarpa.webnode.in/news/incredible-and-alarming-gmp-violations-/

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/

MHRA implements new Software for risk based Inspection Planning

https://seetharamkandarpa.webnode.in/news/mhra-implements-new-software-for-risk-based-inspection-planning/

WHO Guideline on Quality Risk Management finalised

https://seetharamkandarpa.webnode.in/news/who-guideline-on-quality-risk-management-finalised/

Guideline on the European Drug Master File Procedure updated

https://seetharamkandarpa.webnode.in/news/guideline-on-the-european-drug-master-file-procedure-updated/

USP expert answers questions regarding particulate matter testing

https://seetharamkandarpa.webnode.in/news/usp-expert-answers-questions-regarding-particulate-matter-testing/

Final EMA Variations Guideline on Procedures Issues and Classification of Variations published

https://seetharamkandarpa.webnode.in/news/final-ema-variations-guideline-on-procedures-issues-and-classification-of-variations-published/

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/

EU-GMP: New Annex 16 released

https://seetharamkandarpa.webnode.in/news/eu-gmp-new-annex-16-released/

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/

New EMA Inspection Requirements on Good Distribution Practices (GDP)

https://seetharamkandarpa.webnode.in/news/new-ema-inspection-requirements-on-good-distribution-practices-gdp-/

New Requirements of the FDA on Stability Testing of Generic Drugs

https://seetharamkandarpa.webnode.in/news/new-requirements-of-the-fda-on-stability-testing-of-generic-drugs/

Variations: Important Changes in the New Application Form

https://seetharamkandarpa.webnode.in/news/variations-important-changes-in-the-new-application-form/

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/

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/

Updated Procedure for the Renewal and Revision of CEPs!

https://seetharamkandarpa.webnode.in/news/updated-procedure-for-the-renewal-and-revision-of-ceps-/

PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US

https://seetharamkandarpa.webnode.in/news/plair-new-fda-guideline-regulates-import-of-non-approved-drugs-in-the-run-up-to-the-launch-in-us/

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/

GMP and Quality, Responsibility, Integrity, and Accountability - Article

https://seetharamkandarpa.webnode.in/news/gmp-and-quality-responsibility-integrity-and-accountability-article/

WHO revises GMP Guide regarding the Principles of GMP

https://seetharamkandarpa.webnode.in/news/who-revises-gmp-guide-regarding-the-principles-of-gmp/

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/

Qualification, Requalification - frequent Obscurities

https://seetharamkandarpa.webnode.in/news/qualification-requalification-frequent-obscurities/

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/

"SRK GMP OCEAN"- My Mobile Application Works for Android & HTML5

https://seetharamkandarpa.webnode.in/news/srk-gmp-ocean-my-android-application/

European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach

https://seetharamkandarpa.webnode.in/news/european-medicines-agency-and-us-food-and-drug-administration-release-further-guidance-on-quality-by-design-approach/

FDA published List of GMP facilities producing for the US market (generic drug products and APIs)

https://seetharamkandarpa.webnode.in/news/fda-published-list-of-gmp-facilities-producing-for-the-us-market-generic-drug-products-and-apis-/

My new Mobile Application "SRK GMP FAQ"

https://seetharamkandarpa.webnode.in/news/test/

ICH reviews future ICH topics and its Organisation

https://seetharamkandarpa.webnode.in/news/ich-reviews-future-ich-topics-and-its-organisation/

Risk Assessment for ascertaining GMP for Excipients

https://seetharamkandarpa.webnode.in/news/risk-assessment-for-ascertaining-gmp-for-excipients/

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/

My new Mobile Application "SRK CLEANING VALIDATION

https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-cleaning-validation/

GMP for Radiopharmaceuticals - existing and expected Guidelines

https://seetharamkandarpa.webnode.in/news/gmp-for-radiopharmaceuticals-existing-and-expected-guidelines/

EMA now also issues GMP and GDP Non-Compliance Information

https://seetharamkandarpa.webnode.in/news/ema-now-also-issues-gmp-and-gdp-non-compliance-information/

Summary of the new EU GMP Chapters and Annexes

https://seetharamkandarpa.webnode.in/news/summary-of-the-new-eu-gmp-chapters-and-annexes/

My new Mobile Application "SRK GMP Videos"

https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-gmp-videos/

GMP Inspections: Enhanced International Collaboration

https://seetharamkandarpa.webnode.in/news/gmp-inspections-enhanced-international-collaboration/

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 Process Validation Guideline by EMA

https://seetharamkandarpa.webnode.in/news/new-process-validation-guideline-by-ema/

Japanese Pharmacopoeia and Japanese GMP Regulations- online

https://seetharamkandarpa.webnode.in/news/japanese-pharmacopoeia-and-japanese-gmp-regulations-online/

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/

USFDA Warning Letter to Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14

https://seetharamkandarpa.webnode.in/news/usfda-warning-letter-to-novacyl-wuxi-pharmaceutical-co-ltd-12-19-14/

USFDA Inspections/483s Dashboard

https://seetharamkandarpa.webnode.in/news/usfda-inspections-483s-dashboard/

GMP Non-compliance reports (AGEPHA, Austria) Published by EMA

https://seetharamkandarpa.webnode.in/news/gmp-non-compliance-reports-agepha-austria-published-by-ema/

GMP Non-compliance reports (North China Pharmaceutical Group Semisyntech Co., Ltd, China) Published by EMA

https://seetharamkandarpa.webnode.in/news/gmp-non-compliance-reports-north-china-pharmaceutical-group-semisyntech-co-ltd-china-published-by-ema-/

USFDA 483s Published in 2014 by USFDA

https://seetharamkandarpa.webnode.in/news/usfda-483s-published-in-2014-by-usfda/

Good manufacturing practice: data integrity definitions by MHRA

https://seetharamkandarpa.webnode.in/news/good-manufacturing-practice-data-integrity-definitions-by-mhra/

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/

EudraLex V30 - January 2015

https://seetharamkandarpa.webnode.in/news/eudralex-v30-january-2015/

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/

GMP Pre-Inspection Compliance Documents published by MHRA

https://seetharamkandarpa.webnode.in/news/gmp-pre-inspection-compliance-documents-published-by-mhra/

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/

Revision of GMP Data Integrity Definitions from MHRA

https://seetharamkandarpa.webnode.in/news/revision-of-gmp-data-integrity-definitions-from-mhra/

APIC revised the "How to do" Document on ICH Q7

https://seetharamkandarpa.webnode.in/news/apic-revised-the-how-to-do-document-on-ich-q7/

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/

Training presentation on 'How to conduct an effective internal quality audit'

https://seetharamkandarpa.webnode.in/news/training-presentation-on-how-to-conduct-an-effective-internal-quality-audit/

Training Presentation on 'ICH Q10: Pharmaceutical Quality System'

https://seetharamkandarpa.webnode.in/news/training-presentation-on-ich-q10-pharmaceutical-quality-system/

Training Presentation on 'ICH Q9: Quality Risk Management'

https://seetharamkandarpa.webnode.in/news/training-presentation-on-ich-q9-quality-risk-management/

Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)

https://seetharamkandarpa.webnode.in/news/coming-soon/

G.ONE (GMP-ONE)- One Spot for all GMP Links required in our JEEVAN

https://seetharamkandarpa.webnode.in/products/g-one/