What is GMP in India?

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GMP: Electronic Manufacturing System for Small Pharmaceutical Operations What is GMP in India? Richard Soltero, Ph.D. President InstantGMP

description

Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We will examine how well they comply with Good Manufacturing Practices (GMP).

Transcript of What is GMP in India?

Page 1: What is GMP in India?

InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations

What is GMP in India?

Richard Soltero, Ph.D.

President

InstantGMP

Page 2: What is GMP in India?

InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations2

International Conference On Harmonization

ICH Q7A Good Manufacturing Practice Guide

ICH Member Countries –European Union (EU) - 27 countries

Japan

United States

Australia

Canada

Norway

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Basic of GMPs according to ICH

Instructions and procedures are clear and unambiguous (in SOPs)

Manufacturing processes are clearly defined and controlled Records demonstrate that all required steps were taken

Facilities designed to minimize cross-contamination and mix-ups

Operators are trained Distribution minimizes any risk

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Different approaches to GMPs compliance depending on country

There is a global disequilibrium – quality and compliance are different

A nation’s relative development dictates the level of compliance they can afford

ICH signatories have the best quality BRIC nations generally are struggling with

the cost of compliance, even while they recognize the value for international commerce

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GMP Inspections World Wide

PIC/S (Pharmaceutical Inspection Cooperation Scheme)

PIC/S references “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” (ICH Q7A)

Participants include Australia, Canada, Eastern Europe, EU, Malaysia, SA, Singapore, UK, US, Taiwan

Not participating: Brazil, Russia, India, China

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GMP Inspections in India

FDA conducts facility inspections for products to be sold in the USDoesn’t include CTM facilities

Doesn’t include clinical stage products

About 100 Indian facilities have been inspected by the FDA

Otherwise India relies on local inspectors

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GMP in India

Pharma companies in India don’t pay taxes for their first ten years

Over 20,000 pharma companies in India

They don’t go through complex certification procedures

FDA only conducts facility inspections for products to be sold in the US

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GMP Regulations in India Up to 1970, Schedule M of India’s Drug &

Cosmetics Act was in place Advent of GMP requirements covered the

gaps Regulations were harmful to the small players Consolidation of Schedule M and GMP put on

hold until 2005 Amendment of Schedule M is more lenient Small and medium size enterprises are still in

the process of adopting GMPs

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GMP Facilities in India

So the government is giving them some slack

India is considerate of the plight of the small enterprises

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InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations

InstantGMP™ - Making GMP Easy to follow

All-encompassing electronic batch record system that streamlines entire end-to-end production of GMP materials

CFR 21 Part 11-compliant software using an Internet-based infrastructure

Data is automatically visible to everyone at the same time

Maintains quality compliance automatically Helps any company become GMP

compliant

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Comprehensive Solution to GMP Production

Electronic Batch Record System

Streamlines end-to-end production process

Comes with complete set of manufacturing SOPs and Policies

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Batch Production Record –Manufacturing Instructions

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Quick Facts

Developed by the manufacturing and quality experts at PharmaDirections

Integrated application developed using “Quality by Design” approach.

Manufacturing Standard Operating Procedures incorporated into application

Ideally suited for making GMP materials in an international setting

Software has been in use since 2004

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Take Home Messages No one GMP compliance system exists even

in countries that are signatories to ICH India wants to become compliant, but they

have a long way to go Most GMP facilities in India are struggling to

pay for the cost of compliance If you need GMP manufacturing in India, you

have to monitor closely to assure they are in compliance unless the FDA has approved them for making your product

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InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations

www.InstantGMP.com