Tag: seetharam kandarpa

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

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

My new Mobile Application "SRK CLEANING VALIDATION

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

My new Mobile Application "SRK GMP FAQ"

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

My new Mobile Application "SRK GMP Videos"

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

My new Mobile Application "SRK GCP World"

https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-gcp-world/

Elemental impurities: ICH Q3D has reached step 4 (final guideline)

https://seetharamkandarpa.webnode.in/news/elemental-impurities-ich-q3d-has-reached-step-4-final-guideline-/

Seetharam Kandarpa Receives ASQ Quality Auditor

https://seetharamkandarpa.webnode.in/news/seetharam-kandarpa-receives-asq-quality-auditor/

Seetharam Kandarpa Receives ASQ-Certified Pharmaceutical GMP Professional

https://seetharamkandarpa.webnode.in/news/seetharam-kandarpa-receives-asq-certified-pharmaceutical-gmp-professional/

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/

ISO 9001: 2008 Quality Management Systems – Requirements

https://seetharamkandarpa.webnode.in/news/iso-9001-2008-quality-management-systems-requirements/

Good manufacturing practice: data integrity definitions by MHRA

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

FDA Commissioner Margaret Hamburg to Resign Next Month

https://seetharamkandarpa.webnode.in/news/fda-commissioner-margaret-hamburg-to-resign-next-month/

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/

MHRA Warns of People Impersonating its Staff

https://seetharamkandarpa.webnode.in/news/mhra-warns-of-people-impersonating-its-staff-/

GMP Pre-Inspection Compliance Documents published by MHRA

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

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/

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/

Revision of GMP Data Integrity Definitions from MHRA

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

Health Canada Vanessa's Law, effective from November 2014

https://seetharamkandarpa.webnode.in/news/health-canada-vanessas-law-effective-from-november-2014/

TGA finalised the specificationfor the Australian eCTD format submissions

https://seetharamkandarpa.webnode.in/news/tga-finalised-the-specificationfor-the-australian-ectd-format-submissions/

WHO Called for Increased Transparency in Medical Research

https://seetharamkandarpa.webnode.in/news/who-called-for-increased-transparency-in-medical-research/

Indian Government to amend SCHEDULE Y of D&C Rules pertaining to authenticity of data submitted by applicants

https://seetharamkandarpa.webnode.in/news/indian-government-to-amend-schedule-y-of-d-c-rules-pertaining-to-authenticity-of-data-submitted-by-applicants/

Health Canada Launched New Drug and Product Inspections Database

https://seetharamkandarpa.webnode.in/news/health-canada-launched-new-drug-and-product-inspections-database/

FDA's New Pharmaceutical Quality Approach- One Quality Voice

https://seetharamkandarpa.webnode.in/news/fdas-new-pharmaceutical-quality-approach-one-quality-voice/

White paper on "Raising Quality Results on Supplier Audits Using EQMS for Pharmaceutical Companies"

https://seetharamkandarpa.webnode.in/news/white-pape-on-raising-quality-results-on-supplier-audits-using-eqms-for-pharmaceutical-companies/

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 WHO TRS 992 (May 2015) having guidance on Hold time study, Process validationand stirage & transport of products

https://seetharamkandarpa.webnode.in/news/new-who-trs-992-may-2015-having-guidance-on-hold-time-study-process-validationand-stirage-transport-of-products/

Notice by CDSCO regarding administrative action by concerned licensing authority (Dated 04/06/2015)

https://seetharamkandarpa.webnode.in/news/notice-by-cdsco-regarding-administrative-action-by-concerned-licensing-authority-dated-04-06-2015/

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/

USFDA published a final rule (FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products)

https://seetharamkandarpa.webnode.in/news/usfda-published-a-final-rule-fda-2011-n-0898-permanent-discontinuance-or-interruption-in-manufacturing-of-certain-drug-or-biological-products/

Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) [EudraLex - Volume 2]

https://seetharamkandarpa.webnode.in/news/update-of-guideline-on-the-packaging-information-of-medicinal-products-for-human-use-authorised-by-the-union-july-2015-eudralex-volume-2/

Recent Non-compliance Reports Published by EudraGMDP

https://seetharamkandarpa.webnode.in/news/non-compliance-reports-published-by-eudra-gmdp/

New Draft Guidance from USFDA on 'Request for Quality Metrics

https://seetharamkandarpa.webnode.in/news/new-draft-guidance-from-usfda-on-request-for-quality-metrics/

Quality Metrics: Industry Reaction to FDA's Draft Guidance

https://seetharamkandarpa.webnode.in/news/quality-metrics-industry-reaction-to-fdas-draft-guidance/

EDQM released new edition of Technical Guide for the Elaboration of Monographs

https://seetharamkandarpa.webnode.in/news/edqm-released-new-edition-of-technical-guide-for-the-elaboration-of-monographs/

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/

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/

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

https://seetharamkandarpa.webnode.in/news/european-medicines-agency-pre-authorisation-procedural-advice-for-users-of-the-centralised-procedure/

WHO Draft on 'SUPPLEMENTARY GUIDELINES ON GMP FOR HVAC SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS'

https://seetharamkandarpa.webnode.in/news/who-draft-on-supplementary-guidelines-on-gmp-for-hvac-systems-for-non-sterile-pharmaceutical-dosage-forms/

IPEC Federation Published Position Paper on Third Party Audit and Certification Programmes

https://seetharamkandarpa.webnode.in/news/ipec-federation-published-position-paper-on-third-party-audit-and-certification-programmes/

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/

Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

https://seetharamkandarpa.webnode.in/news/reflection-paper-on-the-chemical-structure-and-properties-criteria-to-be-considered-for-the-evaluation-of-new-active-substance-nas-status-of-chemical-substances/

ISO 14644 - Part 1: Final Version on Cleanroom Classification

https://seetharamkandarpa.webnode.in/news/iso-14644-part-1-final-version-on-cleanroom-classification/

Best Practice Guide for Quality Agreements published

https://seetharamkandarpa.webnode.in/news/best-practice-guide-for-quality-agreements-published/

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 revises Guide on Pharmaceutical Water

https://seetharamkandarpa.webnode.in/news/ema-revises-guide-on-pharmaceutical-water/

Recognition of Alternative Compendia (BP/EP/JP) by the FDA

https://seetharamkandarpa.webnode.in/news/recognition-of-alternative-compendia-bp-ep-jp-by-the-fda/

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017

https://seetharamkandarpa.webnode.in/news/meeting-highlights-from-the-committee-for-medicinal-products-for-human-use-chmp-18-21-april-2017/

Regulatory information - adjusted fees for applications to EMA from 1 April 2017

https://seetharamkandarpa.webnode.in/news/regulatory-information-adjusted-fees-for-applications-to-ema-from-1-april-2017/

MHRA's Interpretation of Cross Contamination & PDEs

https://seetharamkandarpa.webnode.in/news/mhras-interpretation-of-cross-contamination-pdes/

EMA Q&A on GCP

https://seetharamkandarpa.webnode.in/news/ema-q-a-on-gcp/

Mentoring Class for ASQ-CQA and ASQ-CPGP

https://seetharamkandarpa.webnode.in/news/mentoring-class-for-asq-cqa-and-asq-cpgp/

ASQ-CQA Exam questions vs chapters vs level of cognition

https://seetharamkandarpa.webnode.in/news/asq-cqa-exam-questions-vs-chapters-vs-level-of-cognition/

Mentoring Classes for ASQ-CQA

https://seetharamkandarpa.webnode.in/news/mentoring-classes-for-asq-cqa/

Mentoring Class for ASQ-CQA

https://seetharamkandarpa.webnode.in/news/mentoring-class-for-asq-cqa/

Web Series Session 1: Overview of ASQ Certified Quality Auditor conducted on 21 May 2017

https://seetharamkandarpa.webnode.in/news/web-series-session-1-overview-of-asq-certified-quality-auditor-conducted-on-21-may-2017/

Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)

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

Web Series 2 of ASQ CQA Mentoring Class: Auditing Fundamentals on 30 July 2017

https://seetharamkandarpa.webnode.in/news/web-series-2-of-asq-cqa-mentoring-class-auditing-fundamentals-on-30-july-2017/

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

https://seetharamkandarpa.webnode.in/news/fda-allows-marketing-of-first-direct-to-consumer-app-for-contraceptive-use-to-prevent-pregnancy/

FDA publishes revised MAPP, ANDA Suitability Petitions (5240.5)

https://seetharamkandarpa.webnode.in/news/fda-publishes-revised-mapp-anda-suitability-petitions-5240-5/

FDA issues final guidance entitled Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

https://seetharamkandarpa.webnode.in/news/fda-issues-final-guidance-entitled-dissolution-testing-and-acceptance-criteria-for-immediate-release-solid-oral-dosage-form-drug-products-containing-high-solubility-drug-substances/

FDA Launches New Medication Guide Database - Drug Information Update

https://seetharamkandarpa.webnode.in/news/fda-launches-new-medication-guide-database-drug-information-update/

Brexit preparedness: EMA to further temporarily scale back and suspend activities

https://seetharamkandarpa.webnode.in/news/brexit-preparedness-ema-to-further-temporarily-scale-back-and-suspend-activities/

Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products

https://seetharamkandarpa.webnode.in/news/targeted-stakeholder-consultation-on-the-draft-guidelines-on-good-clinical-practice-for-advanced-therapy-medicinal-products/

cGMP Guidelines

https://seetharamkandarpa.webnode.in/products/product-1/

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

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