The document discusses Good Manufacturing Practices (GMP) in India, highlighting the differences in compliance levels across countries and the specific challenges faced by Indian pharmaceutical companies. It points out that while Indian firms are not required to follow complex global certification processes, they still must adhere to certain FDA inspections for U.S.-bound products. The InstantGMP system aims to simplify compliance through an electronic batch record system, although significant hurdles related to cost and regulatory adherence remain for many Indian manufacturers.

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

2. 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 Operations
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3. 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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4. 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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5. 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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6. GMP Inspections in India
 FDA conducts facility inspections
for products to be sold in the US
 Doesn’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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7. 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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8. 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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9. GMP Facilities in India
India is considerate of
the plight of the small
enterprises
So the government is
giving them some slack
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10. 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

11. 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 Operations

12. Batch Production Record –
Manufacturing Instructions
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13. 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

14. 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

15. www.InstantGMP.com
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations