What is GMP in India?
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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.
What is GMP in India?
- 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 2
- 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 InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations 3
- 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 InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations 4
- 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 InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations 5
- 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 InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations 6
- 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 InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations 7
- 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 InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations 8
- 9. GMP Facilities in India India is considerate of the plight of the small enterprises So the government is giving them some slack InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations 9
- 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 InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations 12
- 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
Editor's Notes
- #2: Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We are going to examine how well they comply with Good Manufacturing Practices (GMP).>>
- #3: The International Conference on Harmonization defined >>Good Manufacturing Practices in their Q7A Guide for Active Pharmaceutical Ingredients. >>This guide was adopted by the ICH Member Countries including the European Union, Japan, the United States, Australia, Canada and Norway. India is conspicuous by its absence from the ICH Conference.>>
- #4: There guide for GMP compliance is quite large, but the basics can be boiled down to a few key points. >>Instructions and procedures must clear and unambiguous, and most of all written down in standard operating procedures (SOPs). >>Manufacturing processes have to be clearly defined and controlled and records demonstrate that all required steps were taken. >>Facilities have to be designed to minimize cross-contamination and mix-ups. >>Operators have to trained and training documented. >>Finally it has to be shown that distribution of the drugs to the patients minimizes any risks.>>
- #5: While the GMP guide is very complete, there are different approaches to GMP compliance depending on each country. >> There are quite large differences in quality and compliance in different countries. >>In general, a nation’s relative state of development dictates the level of compliance they can afford. >>Countries who are ICH signatories have the best quality. >>BRIC nations including India generally are struggling with the cost of compliance, even though they recognize the value of GMP compliance for selling their product internationally.>>
- #6: So the question is “what is GMP in India”? There is a world wide standard for GMP inspections. >>It’s called the Pharmaceutical Inspection Cooperation Scheme. >>That scheme references “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” (ICH Q7A). >>Participants in this cooperation scheme include Australia, Canada, Eastern Europe, EU, Malaysia, SA, Singapore, UK, US and Taiwan. India is not one of the participating countries.>>
- #7: There are GMP inspections occurring in India. >> The FDA does conduct facility inspections for products that are going to be sold in the US. >> Their inspections don’t include clinical trial manufacturing or facilities used to make just clinical stage products or products to be sold locally. >>So far, about 100 Indian facilities have been inspected by the FDA. >>For all others, India relies on their own local GMP inspectors. >>
- #8: GMP compliance in India is highly influenced by government and business conditions. >> Pharma companies in India don’t pay taxes for their first ten years which is why >> there are over 20,000 pharmaceutical companies there. >>Pharma companies don’t have to go through a complex certification procedure. >>The FDA only conducts facility inspections only for products to be sold in the US, the rest are left to local inspectors.>>
- #9: This has resulted in many GMP facilities in India that very far below international standards. >>Up to 1970, Schedule M of India’s Drug & Cosmetics Act covered only the pharmaceutical company’s location, buildings, equipment, safety and sanitation. >>When GMP requirements were introduced worldwide, it covered the gaps in Schedule M. >> The pharmaceutical manufacturers lobbied in India saying the the Schedule M regulations were harmful to the small players in the pharmaceutical industry. >>The amendment of Schedule M of 2005 which is consolidates with international GMP is more lenient compared with what the US and EU require. >>While small and medium size enterprises are still in the process of adopting GMPs, they are asking to make the existing GMPs even more relaxed.>>
- #10: The Indian administration has been considerate of the plight of the small and medium size enterprises. >>They know that small pharmaceutical companies might be shutdown in some states if all the requirements of GMP are enforced so the government is cutting them some slack. >>
- #11: There is a way to help out small India pharmaceutical companies using software that makes GMP compliance easy. >> For example, InstantGMP is all-encompassing electronic batch record system that streamlines the entire end-to-end production of GMP materials. => It is CFR 21 Part 11-compliant software which means it complies with the FDA requirements for electronic signatures and electronic documentation. >>It uses an internet-based infrastructure so it is a cloud application that can be accessed from anywhere. >>This means users don’t have to install anything on their servers. They just need an internet connection to use it. >>All data is automatically visible to everyone at the same time and can be monitored in real time. >>This software was designed to maintain quality compliance automatically. =>It can help makes any facility GMP compliant for making pharmaceutical materials. >>
- #12: InstantGMP offers a comprehensive solution to GMP production. >> In one system, there are modules for project management, specifications, purchasing, inventory control, room and equipment logs and batch records. >>It is a complete electronic batch record system that streamlines the end to end process of production. >>It comes with a complete set of manufacturing SOPs and Policies.>>
- #13: The InstantGMP Electronic Batch Record system was designed to assure compliance with GMPs. The batch production record shows the level of detail and compliance that is enforced through out the system. This screen provides a complete set of instructions for each of the steps in the manufacturing process. It also has areas where results and comments can be entered by the operator and signed off by a supervisor. If a deviation occurs, it can be quickly documented and then is available for review by a Quality Manager. >>
- #14: >>InstantGMP was developed by the manufacturing and quality experts at PharmaDirections. >>They developed an integrated application using a “Quality by Design” approach that would automate quality and GMP compliance. >>The manufacturing SOP requirements are incorporated into the application. >> It is ideally suited for making GMP materials in an international setting. >> The software is 21 CFR Part 11 Compliant and has been in use since 2004. >>
- #15: There are a few key messages to take home from this presentation. >>In general no one GMP compliance system exists even in countries that are signatories to ICH. >>India does wants to become compliant, but they have a long way to go before all of their industry is fully GMP. >>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 or other regulatory agencies has approved them for making your product.>>
- #16: If you are interested in learning more about the electronic batch record system, please visit www.InstantGMP.com.