This short term programme has been designed mainly to provide current GMP practice and compliance rules and scenarios in the industries world over very comprehensively. The programme provides overview of practical situations and case studies along with details of changing guidelines and compliance rules. Thus it works as re-fresher course for those already in the industry and an insight or practical guide for those planning to enter into this sector.
Module 1: Good Manufacturing Practices and its Regulations (International perspective of USA, WHO, ICH & Europe / Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa / India etc)
Module 2: Qualification and Validation
Module 3: Good Documentation Practices And Record Keeping
Module 4: Manufacturing Operations And Controls In Pharmaceutical Industry
Module 5: Concept Of Quality In Pharmaceutical Industry/Drug Discovery
Module 6: Conducting And Facing Self-Inspection And Quality Audits
Module 7: Basics Of Contract Manufacturing And Analysis
Module 8: Complaint Handling And Product Recall
Module 9: Deviation Management, Capa And Change Control
Module 10: Goodmanufacturing Practices For Active Pharmaceutical Ingredient
Module 11: The Indian GMP Regulation
Module 12: GMP In Other Industries Apart From Pharma
Module 13: Computer System Validation
Module 14: Importance and Principle of Data Integrity
Module 15: Laboratory demonstration of QAQC practicals and Instrument Handling
Module 16: Case Studies
- Records preparation- DMF, MFR, BFR, labeling and packaging records
- Validation and calibration of analytical instruments used in manufacturing
- Documentation for GMP quality control checks for in process and finished products
- Preparation of GMP compliance checklist
- Documentation for product recalls, product complaints, returned goods, change control and CAPA
- Documentation for GMP inspections and audits
The expert lectures along with lab-manufacturing site visits will provide practical skills above and beyond the classroom experience. And it will also provide ample experience in GMP regulations regarding manufacturing, storage and distribution, working environment, documentation for participants to garner the required exposure.
Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
The programme duraion is 6 months.
The registration dates for this bi-annual executive programme run by the Institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.
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.
All the efforts will be made in the form of 3 months internship to provide industrial exposure to the students through internship with pharmaceutical company so that they can have good practical knowledge beyond the classroom experience.
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 obliged to appear for annual exam at the end of the course. After successful completion, the participants will be awarded Executive Diploma in Pharmaceutical Good Manufacturing Practices by Faculty of Good Manufacturing Practice, IGMPI. For all the above mentioned modules elaborate course material and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.
The Institute has partnered with many organizations for providing with placement assistance to in its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.
The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical giants like Mankind Pharma Ltd, GSK Ltd, Syngene International, Torrent Pharmaceuticals, Jubilant LifeSciences Ltd, Granules India Ltd, Dr Reddy’s Laboratories, Ipca Laboratories, Sun Pharma Ltd, Glenmark Generics, Aurobindo Pharma Ltd, Abbott Healthcare Pvt Ltd, Cipla Ltd, Natco Pharma, Mylan Laboratories etc.
From Healthcare product manufacturing to Biotech Products, Food and Beverage manufacturing, GMP is the only and the best tool to ensure production of quality safe products. Our Industry today strongly needs more and more people to know of the GMP regulations and its benefits for the manufacturers as well as for consumers.
The website is thus targeted to make the huge knowledge bank of GMP to its audience with the help of electronic tools as well. Those in the Industry well understand the importance and relevance of GMP. So knowledge of same could help those aspiring to join the Industry or those targeting to setup one such manufacturing unit and even those planning to enter the quality assurance or regulatory affair parallels of Healthcare Industry.
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IGMPI Newsletters
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GMP: A continous process
Fighting fakes with technology
Mr Vinod Arora, Principal Advisor, IGMPI
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