What is GMP in India?
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Transcript of What is GMP in India?
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
What is GMP in India?
Richard Soltero, Ph.D.
President
InstantGMP
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations3
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations4
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations5
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations6
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations7
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations8
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations9
GMP Facilities in India
So the government is giving them some slack
India is considerate of the plight of the small enterprises
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
Comprehensive Solution to GMP Production
Electronic Batch Record System
Streamlines end-to-end production process
Comes with complete set of manufacturing SOPs and Policies
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations12
Batch Production Record –Manufacturing Instructions
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
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
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
www.InstantGMP.com