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: Good manufacturing 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.
Any Indian or overseas applicants must fulfill following criteria for enrolling into the one year Good Manufacturing Practices program. The applicant must be a graduate in any discipline.
Programme duration is 12 months.
The registration dates for this bi-annual programme run by the institute are updated timely on the webpage. The Training sessions and webinars are scheduled preferably on weekends depending on the availability of visiting faculty.. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.
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.
A one-time annual programme fees (lump sum paid at beginning of the course) of Rs. 1,10,000/- (3000 USD for overseas students), which can be paid in installments. This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, every student has to pay an examination fee of Rs 450/-(20 USD for overseas students) per module as per the examination notification of the Institute. 10% of fee concession is applicable to applicants belonging to SC/ST, Physically Handicapped (PH), Ex-servicemen, Defence personnel & their progeny or those who belong to Economically Weaker Section (EWS)/ Below Poverty Line (BPL).
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 Post Graduate Diploma in Pharmaceutical Good Manufacturing Practices. 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. 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 pharmaceutical, healthcare and food giants like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy, Biocon 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.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like