Post Graduate Diploma in Pharmaceutical API Manufacturing (12 months)

Executive Diploma in Pharmaceutical API Manufacturing (6 months)

Industry Certificate in Pharmaceutical API Manufacturing (3-4 months)

www.igmpi.ac.in


About IGMPI


Institute of Good Manufacturing Practices India, registered as a non-profit society (under The Societies Registration Act,1860) with Government of India recognised by Ministry of Commerce & Industry, Government of India, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI) 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, Healthcare and Food 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 a stronger and better training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of quality healthcare and foods is known to our founders and thus numerous efforts are being made to offer friendly but effective and easy regular and online/online sources of GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite 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, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC etc areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India.

The IGMPI's team of technology experts and other Industry advisors together pursue to make cGMP knowledge, training in the area of Pharma and Food manufacturing easily accessible, through this platform.

Accreditation and Awards

IGMPI is recognized by the Ministry of Commerce & Industry Government of India. Duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018 (License number: CRO/QM/L-8004228) for offering education and training programmes in the areas of Pharmaceutical, Food, Nutrition and Healthcare.

Ministry of Commerce & Industry
Bureau of Indian Standards

Institute of Good Manufacturing Practices India (IGMPI) is registered as a non-profit society with its own Memorandum of Association and bye-laws under The Societies Registration Act, 1860, Government of India. IGMPI is an accredited Vocational Institution of Ministry of Education, Government of India.

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

  1. Programme Content
  2. Programme Design
  3. Programme Material
  4. Instructors
  5. Class size & Attendance
  6. Facilities
  7. Evaluation of Students
  8. Written Examination
  9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006. QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

IGMPI's Membership with IPA

IGMPI is a Lifetime Institutional member of Indian Pharmaceutical Association (IPA).

IPA

IGMPI's Membership with AFSTI

IGMPI is an Institutional member of The Association of Food Scientists and Technologists (India), (AFSTI).

AFSTI

Bureau of Indian Standards (BIS)

Bureau of Indian Standards (BIS) came into existence through an act of Parliament in 1987. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. The Bureau is a Body consisting of 25 members representing both Central and State governments, Members of Parliament, industry, scientific and research institutions, consumer organizations and professional bodies; with Union Minister of Consumer Affairs, Food and Public Distribution as its President and with Minister of State for Consumer Affairs, Food and Public Distribution as its Vice-President.

International Recognition

For providing its education and training services to overseas students, IGMPI is registered with the Directorate General of Foreign Trade, Government of India and our Export Import Code is AADCI7680Q.

IGMPI is an Institutional Member of the International Society for Quality in Health Care lSQua

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.


Post Graduate Diploma/Executive Diploma/Industry Certificate in Pharmaceutical API Manufacturing

An active pharmaceutical ingredient (API) is an active component of a specified medicine. Throughout the process of pharmaceutical manufacturing, an API plays a critical role as a medicinal application agent. APIs are major components that must be processed properly to become safe medicine for clinical application. APIs are compounds created through various chemical and biological combinations—not direct raw materials.

The global pharmaceutical industry is huge and the value chain is divided into two categories namely API and finished goods. API forms the basis of the drug that enables it to produce the desired effect. Given the large number of drug releases anticipated, there is a sizable potential API manufacturers, making this one of the most lucrative opportunities available.

This programme will provide a thorough understanding of Pharmaceutical API Manufacturing. This programme provides professionals with the skills and knowledge to allow them to participate effectively in the creation and growth of high impact pharmaceutical aptitude. The development of this programme is in direct response to the demands of industry and its professionals will be highly competitive in the global jobs market. Thus it works as re-fresher programme for those already in the industry and an insight or practical guide for those planning to enter into this sector. You can complete this programme from your own city.

Programme Structure

Module 1: Characteristics of API Product: Chemical and Biological

Module 2: Qualification and Validation

Module 3: Process of Synthesis of APIs from raw materials to finished product

Module 4: Buildings and Facilities: Design, construction, lighting, HVAC & plumbing

Module 5: Equipment: Design, construction,cleaning, &maintenance

Module 6: Fluid handling - Fluid flow, Line sizing, Pressure drop calculation, Pipe network analysis, Pumps & Compressor, Steam, compressed air, ETP, refrigeration & HVAC system

Module 7: Production and Process Controls

Module 8: Laboratory Controls: Test, release for distribution,contaminationand stabilitystudy

Module 9: Intermediate By-Product Recovery and Reuse in API Industry

Module 10: Packaging and Labeling Control of API product

Module 11: Holding and Distribution: Control of Components and Drug Product Containers and Closures Warehouse and distribution procedures

Module 12: Records and Reports: Equipment cleaning log, production records

Module 13: Returned and Salvaged Drug Products, Complaint Handling

Module 14: Pilot Plant - Scale up, Risk assessment and HAZOP study

Module 15: Technology Transfer in Contract Research and Manufacturing Services (CRAMS)

Module 16: Treatment and Disposal of pharmaceutical waste, Environmental aspects, Green processing, Costs of chemical processes

Module 17: Customer relationship and vendor management

Module 18: Industry based Case Studies

Eligibility

Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes

Programme Duration

The duration to complete this program is 1 year (Post Graduate Diploma), 6 months (Executive Diploma) and 3-4 months (Industry Certificate).

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • Assignments for all the programme modules for continuous evaluation and guidance
  • Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants
  • Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination
  • All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable
  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires
  • All learning and training delivery initiatives shall be conducted in English

Examination and Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are expected to appear for an online exam and are also obliged to submit assignments after each module. After successful completion, the participants will be awarded Post Graduate Diploma/Executive Diploma/Industry Certificate in Pharmaceutical API Manufacturing, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global healthcare like Uflex Ltd., Anuroop Packaging Ltd., IPCA, Zydus, Unichem, Sun Pharmaceuticals, Hetero, Torrent Pharmaceutical, Cipla, Lupin, Johnson & Johnson, Pfizer, Roche, Intas, Asrezenenca, Gland, Glenmark, Macleods, Jubilant Lifesciences, Novartis, Merck, Piramal, Dr. Reddy’s Laboratories, Hamdard, Lotus, Lakme, Khadi, Himalayan, Sun Pharmaceutical, Pfizer, PiramalPharma Solutions, Novartis Pharma, IQVIA, Eli Lilly and Company, etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects

API Pharma is one unique sector where the consumer is not the decision maker and the decision maker is not the payer. It is unique in another sense, that there is no product obsolescence. Aspirin, paracetamol and metformin still continue to be gold standards of front line therapy. Hence, scale, quality, compliance and process excellence shall drive growth. Course provides a strong focus on problem solving, Technical, conception, design as well as managerial and practical application of knowledge to particular fact scenarios through a number of advice drafting exercises.


Advisory Board and team


Our Advisory Board Members : https://igmpi.ac.in/advisoryboard.html


C-6, Qutab Institutional Area, Near Old JNU Campus, New Delhi-110016
18001031071 (Toll Free), Phone: +91 11 26512850