Tag: WHAT IS NEW?

FDA publishes GMP Requirements for "Combination Products"

https://seetharamkandarpa.webnode.in/news/fda-publishes-gmp-requirements-for-combination-products/

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/

FDA offers eLearning for eCTD Implementation

https://seetharamkandarpa.webnode.in/news/fda-offers-elearning-for-ectd-implementation/

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/

Dry Heat Sterilization - New USP General Chapter <1229.8>

https://seetharamkandarpa.webnode.in/news/dry-heat-sterilization-new-usp-general-chapter-1229-8-/

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/

WHO publishes Draft on Revised Process Validation Guideline: Validation Life-Cycle Required

https://seetharamkandarpa.webnode.in/news/who-publishes-draft-on-revised-process-validation-guideline-validation-life-cycle-required/

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/

A Major Mistake That Managers Make

https://seetharamkandarpa.webnode.in/news/a-major-mistake-that-managers-make-/

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/

FDA Two new Q&As published for Investigational Drugs

https://seetharamkandarpa.webnode.in/news/fda-two-new-q-as-published-for-investigational-drugs/

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/

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/

New WHO Initiative "Good Pharmacopoeial Practices"

https://seetharamkandarpa.webnode.in/news/new-who-initiative-good-pharmacopoeial-practices/

EU-GMP: New Annex 16 released

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

Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

https://seetharamkandarpa.webnode.in/news/biological-products-human-blood-and-blood-components-intended-for-transfusion-or-for-further-manufacture/

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/

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/

Draft Guideline ICH Q3D for Elemental Impurities published!

https://seetharamkandarpa.webnode.in/news/draft-guideline-ich-q3d-for-elemental-impurities-published-/

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/

Sun Pharma to pay Rs 2517 crore to settle patent suit

https://seetharamkandarpa.webnode.in/news/sun-pharma-to-pay-rs-2517-crore-to-settle-patent-suit/

FDA Releases Guidance on Quality Agreements for Contract Manufacturing

https://seetharamkandarpa.webnode.in/news/fda-releases-guidance-on-quality-agreements-for-contract-manufacturing/

New Stimuli Article on Method Development, Performance Qualification and Performance Verification

https://seetharamkandarpa.webnode.in/news/new-stimuli-article-on-method-development-performance-qualification-and-performance-verification/

FDA issues Guidance for Industry on Risk-Based Monitoring

https://seetharamkandarpa.webnode.in/news/fda-issues-guidance-for-industry-on-risk-based-monitoring/

FDA’s Special Agents: Criminal Investigators

https://seetharamkandarpa.webnode.in/news/fdas-special-agents-criminal-investigators/

Roche to invest $105M into training center

https://seetharamkandarpa.webnode.in/news/roche-to-invest-105m-into-training-center/

New Draft Guidance - Cosmetic Good Manufacturing Practices

https://seetharamkandarpa.webnode.in/news/new-draft-guidance-cosmetic-good-manufacturing-practices/

Wooden's Pyramid of Success - John Wooden's Pyramid of Success

https://seetharamkandarpa.webnode.in/news/woodens-pyramid-of-success-john-woodens-pyramid-of-success/

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

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

Incredible and Alarming GMP Violations

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

EFPIA - What Medicinal Product Manufacturers need to know about the European Verification System EMVS

https://seetharamkandarpa.webnode.in/news/efpia-what-medicinal-product-manufacturers-need-to-know-about-the-european-verification-system-emvs/

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/

FDA Inspection Reports: What are various results and their significance?

https://seetharamkandarpa.webnode.in/news/fda-inspection-reports-what-are-various-results-and-their-significance-/

WHO revises Guideline for Maximum Hold Times

https://seetharamkandarpa.webnode.in/news/who-revises-guideline-for-maximum-hold-times/

WHO revises GMP Guide regarding the Principles of GMP

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

Interesting APIC/CEFIC Guideline for the Qualification of Contract Laboratories

https://seetharamkandarpa.webnode.in/news/interesting-apic-cefic-guideline-for-the-qualification-of-contract-laboratories/

Who should review Batch Record?

https://seetharamkandarpa.webnode.in/news/who-should-review-batch-record-/

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/

EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products

https://seetharamkandarpa.webnode.in/news/ema-guideline-on-the-use-of-bovine-serum-in-the-manufacture-of-human-biological-medicinal-products/

EFPIA selects Microsoft Cloud Platform for the European Verification System against counterfeit Medicines

https://seetharamkandarpa.webnode.in/news/efpia-selects-microsoft-cloud-platform-for-the-european-verification-system-against-counterfeit-medicines/

Changes in the EDQM CEP Database

https://seetharamkandarpa.webnode.in/news/changes-in-the-edqm-cep-database/

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/

FDA Publishes Guidance on Clinical Trials

https://seetharamkandarpa.webnode.in/news/fda-publishes-guidance-on-clinical-trials/

Successor Organisation (IMDRF) of the GHTF

https://seetharamkandarpa.webnode.in/news/successor-organisation-imdrf-of-the-ghtf/

New FDA Guidelines for Medical Devices

https://seetharamkandarpa.webnode.in/news/new-fda-guidelines-for-medical-devices/

EMA publishes Guideline on Pharmaceutical Development of Medicines for Paediatric Use

https://seetharamkandarpa.webnode.in/news/ema-publishes-guideline-on-pharmaceutical-development-of-medicines-for-paediatric-use/

Quality by Design: Lessons learnt from EMA/FDA Pilot Program

https://seetharamkandarpa.webnode.in/news/quality-by-design-lessons-learnt-from-ema-fda-pilot-program/

FDA Guide on Import of Drugs prior to approval

https://seetharamkandarpa.webnode.in/news/fda-guide-on-import-of-drugs-prior-to-approval/

Black Triangle: a New EU Requirement

https://seetharamkandarpa.webnode.in/news/black-triangle-a-new-eu-requirement/

U.S. Government Shutdown: Consequences for the FDA

https://seetharamkandarpa.webnode.in/news/u-s-government-shutdown-consequences-for-the-fda/

USP Draft of a newly proposed Chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products

https://seetharamkandarpa.webnode.in/news/usp-draft-of-a-newly-proposed-chapter-1115-bioburden-control-of-nonsterile-drug-substances-and-products/

U.S. FDA Clearance for Mass Spectrometry

https://seetharamkandarpa.webnode.in/news/u-s-fda-clearance-for-mass-spectrometry/

New MHRA's Webpage on the Falsified Medicines Directive

https://seetharamkandarpa.webnode.in/news/new-mhras-webpage-on-the-falsified-medicines-directive/

FDA Scientists link transfused UVB irradiated platelets with acute lung injury

https://seetharamkandarpa.webnode.in/news/fda-scientists-link-transfused-uvb-irradiated-platelets-with-acute-lung-injury/

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-/

Qualification, Requalification - frequent Obscurities

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

Cleaning Validation Requirements in Asia

https://seetharamkandarpa.webnode.in/news/cleaning-validation-requirements-in-asia/

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/

Revision of USP Chapter on IR Spectroscopy

https://seetharamkandarpa.webnode.in/news/revision-of-usp-chapter-on-ir-spectroscopy/

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/

"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/

Stability Testing of Generics: FDA publishes Q&A Document

https://seetharamkandarpa.webnode.in/news/stability-testing-of-generics-fda-publishes-q-a-document/

EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

https://seetharamkandarpa.webnode.in/news/ema-guideline-on-quality-of-biological-active-substances-produced-by-transgene-expression-in-animals/

1997 - 2003 - 2013: Quo vadis 21 CFR 11?

https://seetharamkandarpa.webnode.in/news/a1997-2003-2013-quo-vadis-21-cfr-11-/

EMA publishes revised dossier-submission requirements for active-substance master files

https://seetharamkandarpa.webnode.in/news/ema-publishes-revised-dossier-submission-requirements-for-active-substance-master-files/

FDA Launched Secure Supply Chain Pilot Program

https://seetharamkandarpa.webnode.in/news/fda-launched-secure-supply-chain-pilot-program/

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/

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/

New FDA Fees for Drug Master Files published

https://seetharamkandarpa.webnode.in/news/new-fda-fees-for-drug-master-files-published/

Revision of the USP Chapter on Packaging and Storage Requirements <659>

https://seetharamkandarpa.webnode.in/news/revision-of-the-usp-chapter-on-packaging-and-storage-requirements-659-/

USP visual inspection expert answers for question regarding AQL testing

https://seetharamkandarpa.webnode.in/news/usp-visual-inspection-expert-answers-for-question-regarding-aql-testing/

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/

Dun and Bradstreet Verification in the EU Site Master File?

https://seetharamkandarpa.webnode.in/news/dun-and-bradstreet-verification-in-the-eu-site-master-file-/

FDA is proposing a regulation to implement administrative detention authority during inspections

https://seetharamkandarpa.webnode.in/news/fda-is-proposing-a-regulation-to-implement-administrative-detention-authority-during-inspections/

Article on the consequences of non-compliance

https://seetharamkandarpa.webnode.in/news/article-on-the-consequences-of-non-compliance/
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