This document provides an overview of consulting services offered by Sai Pharma Solutions Inc. related to quality management, regulatory affairs, and GMP compliance for pharmaceutical industries. The company's vision is to help clients achieve global regulatory compliance through education, training, auditing, and documentation services. Key services include GAP analyses, audits and checklists, SOP development, regulatory submissions, technical support, and online consultations. The goal is to help clients obtain regulatory approval by ensuring their facilities, equipment, methods, and personnel meet all necessary qualifications and standards.
The European Commission Health and Consumers Directorate โ General has published draft โGUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USEโ for public consultation.
Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.
Manage compliance with the Guideline on 'the formalised risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use'
PIC/S Guide to GMP PE009-13 - Key changes to Annex 15 - Qualification and val...TGA Australia
ย
The TGA has now legislated version 13 of the PIC/S guide to GMP for medicinal products with a transition period for implementation ending at the end of 2018. Some of the biggest changes in this version were in Annex 15 โ Qualification and Validation. This has an impact across all areas in including small to medium sized manufacturers as well as sponsors who need to understand the impact in their supply chain including contract manufacturing and storage and transportation.
Institute of Good Manufacturing Practices India, registered as a non-profit society with Government of India and a member (as a higher/professional Education Institute) of Quality Council of India(QCI) -which is an autonomous body and an accreditation authority for education & vocational training providers under the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.
Our group of learned professionals from above mentioned sectors of the pharma and healthcare industries have put together their knowledge; know about and practical experiences in form of this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as stronger and better training & distance and e-learning platform provider for pharmaceutical and healthcare professionals in the aeas of GMP, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of quality healthcare is known to our founders and thus numerous efforts are being made to offer friendly but effective and easy online/distance sources of GMP information, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice in form of online seminars, distance/online courses as well as training programmes along with knowledge of worldwide affairs of the industry; in short a round-the-clock help for any information in these areas needed by anybody from around the world. Based on high standard of quality, the training programmes in Pharma and healthcare GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management etc areas have been approved and certified by Quality Council of India.
The IGMPIs team of technology experts and other Industry advisors together pursue to make cGMP knowledge, training in the area of Pharma and healthcare manufacturing easily accessible, through this platform.
The European Commission Health and Consumers Directorate โ General has published draft โGUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USEโ for public consultation.
Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.
Manage compliance with the Guideline on 'the formalised risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use'
PIC/S Guide to GMP PE009-13 - Key changes to Annex 15 - Qualification and val...TGA Australia
ย
The TGA has now legislated version 13 of the PIC/S guide to GMP for medicinal products with a transition period for implementation ending at the end of 2018. Some of the biggest changes in this version were in Annex 15 โ Qualification and Validation. This has an impact across all areas in including small to medium sized manufacturers as well as sponsors who need to understand the impact in their supply chain including contract manufacturing and storage and transportation.
Institute of Good Manufacturing Practices India, registered as a non-profit society with Government of India and a member (as a higher/professional Education Institute) of Quality Council of India(QCI) -which is an autonomous body and an accreditation authority for education & vocational training providers under the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.
Our group of learned professionals from above mentioned sectors of the pharma and healthcare industries have put together their knowledge; know about and practical experiences in form of this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as stronger and better training & distance and e-learning platform provider for pharmaceutical and healthcare professionals in the aeas of GMP, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of quality healthcare is known to our founders and thus numerous efforts are being made to offer friendly but effective and easy online/distance sources of GMP information, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice in form of online seminars, distance/online courses as well as training programmes along with knowledge of worldwide affairs of the industry; in short a round-the-clock help for any information in these areas needed by anybody from around the world. Based on high standard of quality, the training programmes in Pharma and healthcare GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management etc areas have been approved and certified by Quality Council of India.
The IGMPIs team of technology experts and other Industry advisors together pursue to make cGMP knowledge, training in the area of Pharma and healthcare manufacturing easily accessible, through this platform.
European Medicines Agency has issued a new guidelines describing stability testing requirements for variations to a marketing authorisation after approval, setting out the differing requirements for changes to active pharmaceutical ingredients (API) and finished dosage form production.
Manufacturers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to these new guidelines.
On January 22, 2013 the China SFDA published a Good Supply Practice guidance that will be implemented on June 1, 2013. Businesses will have a 3 year period to phase in the requirements and if this has not been accomplished by the deadline in 2016 they will be required to cease their activities. This is another demonstration that China is working diligently to upgrade the quality of their pharmaceutical manufacture and distribution networks.
The guidance significantly increases the requirements for Quality Management. The relevant chapters include: General Provisions, Drug Wholesale Quality Management, Drug Retail Quality Management, and Supplementary provisions. Significant emphasis is placed on the standards to be implemented for computerized hardware and software systems. The use of controlled computerized systems is intended to both be an aid in protection of drug quality but will also serve as a barrier to entry into this part of the pharmaceutical business.
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
ย
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
In the month of February 2014 US Food and Drug Administration Commissioner Margaret Hamburg visited India to discuss issues of drug quality with her counterparts in the Indian Government. The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market. India is second only to Canada as a drug exporter to the United States, where it supplies about 40 percent of generic and over-the-counter drugs.There were comments made about the US and Indian GMP Standards. Drug Regulations has now compared the GMP standards of US and India. The comparison is given in the presentation here.
This presentation gives a overview of the new FDA draft guidance on Analytical Method Validation and compares it with the older version issued in the year 2000.
European Medicines Agency has issued a new guidelines describing stability testing requirements for variations to a marketing authorisation after approval, setting out the differing requirements for changes to active pharmaceutical ingredients (API) and finished dosage form production.
Manufacturers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to these new guidelines.
On January 22, 2013 the China SFDA published a Good Supply Practice guidance that will be implemented on June 1, 2013. Businesses will have a 3 year period to phase in the requirements and if this has not been accomplished by the deadline in 2016 they will be required to cease their activities. This is another demonstration that China is working diligently to upgrade the quality of their pharmaceutical manufacture and distribution networks.
The guidance significantly increases the requirements for Quality Management. The relevant chapters include: General Provisions, Drug Wholesale Quality Management, Drug Retail Quality Management, and Supplementary provisions. Significant emphasis is placed on the standards to be implemented for computerized hardware and software systems. The use of controlled computerized systems is intended to both be an aid in protection of drug quality but will also serve as a barrier to entry into this part of the pharmaceutical business.
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
ย
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
In the month of February 2014 US Food and Drug Administration Commissioner Margaret Hamburg visited India to discuss issues of drug quality with her counterparts in the Indian Government. The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market. India is second only to Canada as a drug exporter to the United States, where it supplies about 40 percent of generic and over-the-counter drugs.There were comments made about the US and Indian GMP Standards. Drug Regulations has now compared the GMP standards of US and India. The comparison is given in the presentation here.
This presentation gives a overview of the new FDA draft guidance on Analytical Method Validation and compares it with the older version issued in the year 2000.
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
Regulatory Services: CTD/NTA to eCTD, Product Life-cycle Management (Renewal and Variation), Country specific Dossiers, Device master File, PV system, Patent (searching, drafting, filing), Technology transfer etc.
Call me for further discussion: +91-8800520825//9264127040
mail: reg.medwisdom@gmail.com
website: www.medwisdom.in
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Sai pharma solutions inc scientific-regulatory affairs-qms and c gmp consultants
1. INSIGHT OF OUR QUALITY MANAGEMENT AND
REGULATORY AFFAIRS CONSULTING SERVICES
By:
J.Ramniwas(M.Sc , M.Phil โMedicinal Chemistry)
Founder and CEO
Sai Pharma Solutions Inc, Vadodara(India)
2. Introduction
Sai Pharma Solutions Inc is a boutique consultancy to
the pharmaceutical industries dealing in
1. API Manufacturing
2. Drug Product Manufacturing
3. Cosmetic Manufacturing
4. Ayurvedic and Herbal Product Manufacturing
5. Biological/ Biotechnological Product Manufacturing
We consult and train on Regulatory , GMP , Quality compliance,
Drug registration, validation, qualification and continuous
improvement of manufacturing process.
2
3. Our Vision
Preparing Pharmaceutical Industries/Institutes for Global
Regulatory Compliance by education, training, auditing,
documentation and regulatory submissions by way of generating
awareness among the pharmaceutical entrepreneurs regarding
the future course of the regulatory mechanism and increasing
customer's expectations consequential technical upgradation for
pharmaceutical manufacturing facilities.
3
4. Our Mission
1. Making Pharmaceutical Industries/ Institutes appreciate the need to change and
prepare a systematic action plan for reviewing โManufacturing Activities and
Quality Systemsโ vis-a-vis traditional approach of prioritizing marketing focus.
2. To provide Comprehensive understanding of global regulatory guidelines enabling
the pharmaceutical organizations to assess their shortcomings.
3. Create awareness about the minimum basic level of production systems i.e.
manufacturing facilities, design, equipment and quality management systems like
documentations and controls etc.
4. To generate positive outlook to face the challenge confidently rather than taking
the escape route i.e. wait and watch policy or believe inโ Whatever will happen to
the others will happen to meโ.
5. Generating a perfect clarity about the regulatory impact โ its positive
interpretation and approach to implement the necessary changes in technology
and business plans.
6. Developing an insight among the Pharmaceutical industries/institutes' to prepare
challenges of Globalization.
4
5. Goal is : Regulatory Approval
Regulatory Approval Requires:
1. Qualified Facilities
2. Qualified Equipments ,Instruments and Utilities
3. Qualified Methods and Processes
4. Qualified personnel
Sai Pharma Solutions Can Support to cater all
the above Requirements.
5
6. What We Offerโฆโฆ?
1. Providing consulting and resources for validation and qualification activities
2. Consulting on how to combine GMP compliance with Total Quality
Management(TQM) and continuous improvement techniques.
techniques.
3. Consulting on GxP compliance
4. Consulting on Quality Compliance
5. Consulting on Regulatory Compliance
6. Training People in Validation, GMP Compliance, Documentation, Continuous
improvement and career enhance training in RA,QA,QC,ADL, Manufacturing, IPR
etc.
etc.
7. Consulting on USFDA,PMDA,Japan, EU, EDQM,TGA, MCC,MHRA and Rest of the
world(ROW) Drug registration
We tackle validation, qualification, registration, documentation compliance and
Continuous improvement projects on a fixed price or hourly rate basis.
basis.
6
7. Our Team Includes
1. Regulatory Affairs Consultants
2. Professional Trainers
3. Validation Consultants
4. Pharmaceutical Engineers
5. R&D and F&D Experts
6. GMP Consultants
7. Quality Management Consultants
8. Analytical Development and Validation Consultants
7
8. We Offer : GAP Analysis
We undertake GAP analysis for the following activities:
1. Design Support for the upcoming manufacturing facilities.
2. New Manufacturing building and facilities
3. New Laboratory Establishment
4. Quality System Development and Implementation
5. To meet global regulatory requirements
6. Existing facilities for Quality System Improvement
8
9. We Offer : Audits and Checklists
We undertake Audit services and provide checklists for :
1. Internal Audits
2. Third Party Audits for Vendor Qualification
3. Mock audits prior to Regulatory and Customer Audits
4. Support for Audit Preparation
5. Audit Checklists
6. Master Document Check List
9
10. We Offer : Standard Operating Procedures
We identify SOPs as per your business module, prepare
them and impart training prior to their implementation:
1. System SOPs
2. General SOPs
3. Cleaning and Sanitation SOPs
4. Passivation SOPs
5. Departmental SOPs : QA,QC, Personnel & Admin,
Microbiology, Engineering, R&D and Warehouse etc.
6. Validation and Qualification SOPs
7. Operation and Calibration SOPs
8. Preventive Maintenance SOPs
10
11.
12.
13.
14.
15.
16. We Offer: Scientific and Technical Discussions
We tackle your scientific and technical queries pertaining to
regulatory/ GMP/ Quality compliance:
compliance:
16
17. We Support in: Product and Business Development
We extend support both the vendors and customers for business
development through a strategic alliance and agreements. We
agreements.
support for:
for:
17
18. We Offer: Online Consultancy
Our company is the in India to be
based entirely on the Internet. We work closely with experienced and highly skilled
professional GMP experts from around the world, allowing you to benefit from their wide-
ranging knowledge and expertise. As a result, pharmaceutical companies no longer need to
spend several thousands of dollars on conventional consulting services to gather GMP-
related information.
Our role is to find the right answers to your questions and provide advice as and when you
need it. We specialize in conducting GMP and quality reviews in both English and local
languages for batch records, annual product reviews, investigations, complaints and
deviations, etc. We can also assist you in the creation of documentation such as master batch
records and standard operating procedures (SOPs).
We also provide key pharmaceutical document templates such as SOPs, master plans and
training modules to support your daily cGMP affairs. Whatโs more, as an Internet-based
consultancy, we donโt generate costly travel and hotel expenses. Instead, we focus entirely on
the task in hand โ providing you and your company with precisely the advice or
documentation you need in the most cost-effective manner.
18
19. Why Sai Pharma Solutionsโฆ..?
There are many reasons that you get associated with us for all Regulatory Affairs,
Quality and GMP compliance solutions. Some of them are enumerated below:
19
20. Our Esteemed Customers
We have customers in various pharmaceutical fields in India and overseas to whom
we are providing our value added services on continuous basis. Our Indian customers:
1. Titan Laboratories Private Limited 23. Amoli Organics Pvt Ltd
2. Titan Pharma Pvt Limited 24. UBM India Limited
3. Nivika Chemo Pharma Private Limited 25. Anamayee Pharmachem Pvt Ltd
4. Suchem Laboratories
5. Suleshvari Pharma
6. Dolphin Chem
7. Anuh Pharma Limited
8. Orex Pharma Private Limited
9. Apex Healthcare Limited
10. Great Pacific Export Limited
11. Anan Drugs and Chem Limited
12. Annamalai University
13. Gujarat University
14. Asia Business Forum
15. IBC(Asia)
16. Parul Institute of Pharmacy
17. Isomatric Health Care Limited
18. Adani Pharmachem Private Limited
19. Benzo Petro International Limited ( Arch Pharmalabs Limited)
20. SICART
21. Zephyr Synthesis Private Limited
22. Rubamin Limited(Pharma Division)
***In addition to India, we have customers in South Asian countries and other parts of the world.
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21. Contact us for business association
J.RAMNIWAS
( Founder and CEO)
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