Two additional EU member states join EU-US Mutual Recognition Agreement to carry out Good Manufacturing Practice

Institute of Good Manufacturing Practices India
Global accredited training & certification provider
Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India
Approved Training Institute of Food Safety and Standards Authority of India (FSSAI)
Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India
An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC) set up by National Skill Development Corporation (NSDC)
Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD & ASSOCHAM Services Excellence Award 2017

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24 February 2018

Indian Pharma Stands Strong in Global markets

UK MHRA Suggests Little Changes to Regulatory Framework

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Health-ministry-constitutes-DTAB-sub-committee-to-re-examine-banned

Namballa Mohana Rao

(PQA-2552)

Aurobindo Pharma Ltd.
Post Graduate Diploma in Quality Assurance and Quality Control

Loganathan Kaliaperumal

(PQA-2554)

Medtronic
Post Graduate Diploma in Quality Assurance and Quality Control

Vishal Chaudhary

(EPV 2561)

International Panacea Ltd.
Executive Diploma in Pharmacovigilance

Neha Rajeev Deolekar

(EPV 2557)

Alkem Healthcare
Executive Diploma in Pharmacovigilance

Sudarshana Bag

(PGCR-2559)

Novartis
Post Graduate Diploma in Clinical Research

Karen Sylvia D'Souza Pereira

(ICPCR 2551)

Piramal Life Sciences Ltd.
Industry Certificate in Clinical Research

Shweta Shantanu Joshi

(PRA-2586)

Cipla Ltd.
Post Graduate Diploma in Regulatory Affairs

Ramakant Gaur

(PRA-2602)

Zydus Cadila
Post Graduate Diploma in Regulatory Affairs

Krunal Mahesh Rathod

(EPPM-2552)

Johnson and Johnson
Executive Diploma in Pharma Product Management

Hemant Mehta

(EPPM 2555)

Lupin Ltd.
Executive Diploma in Pharma Product Management

Smita Ashwin Patel

(PGMP-2551)

Glenmark Generics Ltd.
Post Graduate Diploma in Good Manufacturing Practices

Wasiuddin Pasnamiyan Biradar

(PGMP-2558)

Wockhardt
Post Graduate Diploma in Good Manufacturing Practices

Rinku Ravikant Khathuria

(PGMW 2552)

McCANN Health
Post Graduate Diploma in Medical Writing

Sri Divya Guttikonda

(EMW 2552)

Quintiles
Executive Diploma in Medical Writing

Keerthi Priya

(PPNT 2553)

Daewoong Pharmaceuticals
Post Graduate Diploma in Nanotechnology

Kalanadhabhatla Kamala Sruthi

(EDHI 2551)

Mediassist India TPA Ltd.
Executive Diploma in Heath Informatics

Godwin Amema Benjamin

(EPHHM 2555)

Megacare Ltd.
Executive diploma in Public Health and hospital management

Amita Harnal

(PGPHHM 2552)

Bakson's Allergy Center
Post Graduate Diploma in Public Health and hospital management

Sudhansu Shekhar Panda

(EIPR-2554)

Torrent Research Center
Executive Diploma in Intellectual Property Rights

Navya Roshan

(EIPR-2556)

Merck Millipore
Executive Diploma in Intellectual Property Rights

Sandhya Sandip Bodke

(EGLP 2551)

Apar Industries Ltd.
Executive Diploma in Good Laboratory Practices

Ruby Kashyap

(ERA-2674)

Sun Pharma Industries
Executive Diploma in Regulatory Affairs

Abhishek Agrawal

(ERA-2675)

Mankind Pharma
Executive Diploma in Regulatory Affairs

Ramendra Gaurh

(ERAP 2551)

Abbott Pharma
Executive Diploma in Regulatory Affairs

Kalachar H.C.B

(PGGLP 2551)

Sensacore Medical Instrumentation Pvt. Ltd., Hyderabad
Post Graduate Diploma in Good Laboratory Practices

Ujjawal Anil Yadav

(ICPDDD 2551)

Emil Pharmaceuticals
Industry Certificate in Drug Discovery and Development

Jayesh Kumar Hasmukhbhai Gohel

(PGPSMM 2551)

G.S.K. Pharma
Post graduate Diploma in Pharmaceutical Sales and Marketing Management

Ranu jain

(PGPSMM 2552)

ABBOTT
Post Graduate Diploma in Pharmaceutical Sales and Marketing Management

Sarthak Adak

(EMDM 2552)

Mindteck India Ltd.
Executive Diploma in Medical Device Management

Khudus Khan

(EMDM 2554)

Medtronic
Executive Diploma in Medical Device Management

Atul Raghvendra Takalkar

(PQA-2572)

Sandoz Pvt. Ltd.
Post Graduate Diploma in Quality Assurance and Quality Control

Sravana Kumar Chinta

(PQA-2618)

Dr. Reddys Laboratories
Post Graduate Diploma in Quality Assurance and Quality Control

Anshumouli Bhardwaj

(EQA-2555)

Panacea Biotech
Executive Diploma in Quality Assurance and Quality Control

Shikha Kothiyal Tiwari

(EMCP 2552)

Akons Drugs and Pharmaceutical Ltd.
Executive Diploma in Medical Coding

V.S.Sureshkumar Sista

(ECR-2552)

EISAI Pharma Manufacturing Pvt. Ltd.
Executive Diploma in Clinical Research

Anju Dharmesh Murabia

(ECR-2554)

Centaur Pharma Pvt. Ltd.
Executive Diploma in Clinical Research

Abhijit Chanda

(PRA-2623)

Baxter India Pvt. Ltd.
Post Graduate Diploma in Regulatory Affairs

Pankti Rajal

(PRA-2582)

Colgate Palmolive Ltd.
Post Graduate Diploma in Regulatory Affairs

Aparna Ashok Gaikwad

(PRA-2616)

Emcure Pharmaceuticals Ltd.
Post Graduate Diploma in Regulatory Affairs

Vikas Sukadeo Jangale

(EPPM 2553)

Life Science, Pune
Executive Diploma in Pharma Product Management

Mohammed Asadullah Jahangir

(EIPR-2553)

Pharma Compass
Executive Diploma in Intellectual Property Rights

Parika Motirambhai Vasava

(PGPHHM 2561)

Stemade Biotech Pvt. Ltd.
Post Graduate Diploma in Public Health and hospital management

Hemant Singh

(PGPHHM 2562)

Apollo Hospitals ENT Ltd.
Post Graduate Diploma in Public Health and hospital management

Surya S Muraleekumar

(PGMW 2553)

Piramal
Post Graduate Diploma in Medical Writing

Athena Natasha Ferrao

(PGMW 2554)

Themis Medocare Ltd.
Post Graduate Diploma in Medical Writing

Ritu Singh

(EPV 2553)

Ranbaxy Research Laboratories
Executive Diploma in Pharmacovigilance

Lokesh Mahale

(EPV 2554)

Coiorcon Asia Pvt. Ltd.
Executive Diploma in Pharmacovigilance

Dipa Amit Sarkar

(PGGLP 2552)

Praj Industries Ltd.
Post Graduate Diploma in Good Laboratory Practices

P.C. Nathan

(PGGLP 2553)

Marico
Post Graduate Diploma in Good Laboratory Practices

Virendra Vinayak Suryawanshi

(EMDM 2551)

Hetero Labs Ltd.
Executive Diploma in Medical Device Management

Jaishri Meghanathan

(PGMDM 2557)

Dyansys India pvt.ltd
Post Graduate Diploma in Medical Device Management

Rajesh Vasudev Kannav

(PGMP-2561)

IPCA Labs Ltd.
Post Graduate Diploma in Good Manufacturing Practices

Mr. Jayakrishnan Chakkalackal Somasundaram

(PGMP-2565)

Elite Foods
Post Graduate Diploma in Good Manufacturing Practices

Pankaj Kumar Upadhyay

(PGPHHM 2557)

Sickle cell Institute C.G. Pt. J.N.M. Campus
Post Graduate Diploma in Public Health and hospital management

Aparna Anil Manjrekar

(PGPHHM 2558)

Tata Memorial Hospital
Post Graduate Diploma in Public Health and hospital management

Manjula Shankar Mada

(PQA-2576)

Thyrocare Technologies Limited
Post Graduate Diploma in Quality Assurance and Quality Control

Puneet Vairale

(PQA-2579)

Mylan Lab, R&D, Hyderabad
Post Graduate Diploma in Quality Assurance and Quality Control

Lakshmi A.S

(PQA-2580)

HLL Lifecare Ltd.
Post Graduate Diploma in Quality Assurance and Quality Control

Mr. R.Veneshkumar

(PGMP-2569)

Sterling Biotech Ltd.
Post Graduate Diploma in Good Manufacturing Practices

Rajan Kumar Verma

(PGMP-2570)

Perrigo
Post Graduate Diploma in Good Manufacturing Practices

Vishnu Datt Tiwari

(PQA-2619)

Alembic Pharmaceutical
Post Graduate Diploma in Quality Assurance and Quality Control

Rahul Prabhakar Kawale

(PQA-2624)

Intas Biopharma, Ahmadabad
Post Graduate Diploma in Quality Assurance and Quality Control

F. Mary Jansi

(PRA-2624)

Meyer Organics
Post Graduate Diploma in Regulatory Affairs

Sumalatha Sanivarapu

(PRA-2629)

GVK Biosciences
Post Graduate Diploma in Regulatory Affairs

December 28, 2017

The Maharashtra FDA Issues Suspension of Licenses Basis Non-Compliance

Over the past six months, Maharashtra Food and Drug Administration (FDA) has cancelled 278 retail licenses and suspended 1,439 licenses across the state for non-compliance to Drugs and Cosmetics Act. This action is an outcome of state drug regulator’s routine inspections on drug retail shops and 2908 wholesale inspections. .....

Glenmark is Served With Form 483 at its Baddi Plant, Himachal Pradesh

The US Food and Drugs Administration (FDA) has served Glenmark, an Indian manufacturer, Form 483 citing observations relating to violation of good manufacturing practices which the inspectors noticed while inspecting the Baddi Plant.

Long Awaited Draft to Annex 1 on Sterile Manufacturing Published

The European Commission has released the long awaited draft of Annex 1“Manufacture of Sterile Medicinal Products”. The draft is open for public consultation from 20 December 2017 until 20 March 2018. Since the first publication took place in 1971, Annex 1 on sterile manufacturing has undergone a number of focused updates.

Non-Compliance ASU&H Drug Manufacturers

In a statement released by Government of India, out of 8,667 licenced Ayurvedic, Siddha, Unani and Homoeopathy (ASU&H) drug manufacturers in the country, 1179 are reported to be non-compliant with the prescribed Good Manufacturing Practices (GMP).

GMP News & Guidelines Archives:

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Honourable Dr. G. N. Singh, Drug Controller General of India presented a Momento by our Director Mr. Syed S. Abbas & Principal Advisor Mr. Vinod Arora on the launch of our Computer System Validation (CSV) programme

Dr. A.P.J.Abdul Kalam,Honorable Former President of India releasing the first Issue of our Lab World Magazine along with our Chief Advisor & Editor Dr Mahesh C Gupta

IGMPI is conferred with ASSOCHAM Services Excellence Award 2017: Our Directors Mr Syed S. Abbas & Mrs Rafat Abedi, Chief Advisor Dr Mahesh Gupta, Advisor Mr Amitabh Srivastava are being honoured by the Chief Guest & Honorable Member of Parliament Dr. Udit Raj

(L-R) Seetaraju Gembali, Managing Director, GSR Pharma Research; Vinod Arora, Principal Advisor, IGMPI (Moderator); Dr Girish Jain, President, Research & Development, Alkem Laboratories and Pramod Pimplikar, Managing Director, Shalina Laboratories

Conferment of Quality Council of India (QCI) - D.L. Shah National Quality Award

Targeting to fill up the gap between the existing and accessible knowledge

Whose work ideology revolves around its sole vision to make available reliable and efficient professionals to the Industry

With the values of Quality, Flexibility, Excellence & Professionalism

Whose work ideology revolves around its sole vision to make available reliable and efficient professionals to the Industry

Targeting to fill up the gap between the existing and accessible knowledge

Educating todays learners for tomorrows world

Whose work ideology revolves around its sole vision to make available reliable and efficient professionals to the Industry

Educating todays learners for tomorrows world

Two additional EU member states join EU-US Mutual Recognition Agreement to carry out Good Manufacturing Practice

Two additional EU member states -Lithuania and Ireland have joined The US Food and Drug Administration (FDA) to carry out Good Manufacturing Practice inspections at a level equivalent to the US as confirmed by European Medicines Agency (EMA).

After it was confirmed by European Commission in June 2017 that FDA has the capability, capacity and procedures to carry out GMP inspections at a level equivalent to the EU, eight member states (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom) were included by FDA on 1st Nov 2017 to carry out GMP inspections equivalent to EU whereas on 1st Mar 2018 additional four states were also recognized. After inclusion of Lithuania and Ireland, now there are 14 EU member states which are included in an agreement allowing FDA to rely on European Commission inspection results to replace their own inspections.

The mutual recognition agreement between EU and US regulators has the following benefits:

1) Duplication avoided as information is being continuously exchanged regarding GMP inspections of manufacturing sites
2) Lead to better use of resources for inspection of higher risk manufacturing sites
3) Irrespective of manufacturing sites, patients can rely on the quality, safety and efficacy of all medicines
4) Improvement in identification of potential risks and addressing the problems at manufacturing sites before making it a possible public health risk
5) Reduction in the burden and cost of duplicative inspections

According to EMA,” Around 40% of finished medicines marketed in the EU come from overseas and for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union. This is the reason why every year national authorities across the EU, alongside FDA, inspect many manufacturing sites of medicines in the EU, US and elsewhere to ensure compliance with GMP.

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Two additional EU member states join EU-US Mutual Recognition Agreement to carry out Good Manufacturing Practice

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