The international standard of GLP or Good Laboratory Practice is a quality system used in research labs. As part of their responsibility, scientists have conventionally adopted good laboratory practices directed at ensuring the quality of their data. Nevertheless, until recently these practices were not consistently adopted or enforced. But, now national and international agencies have developed guidelines aimed at various industries (food, agriculture, pharmaceutical, clinical, biotech, cosmetics, environmental, etc.) which fall in the general category of Good Laboratory Practices (GLP).
Since the issue of GLP is so important to modern laboratory operations, this programme will incorporate many of the principles that are part of GLP in contemporary commercial laboratories. It will be useful for next generation individuals seeking careers in the industry who need practical skills and expertise for the pharmaceutical, biotechnology and healthcare workforce.This curriculum is specifically designed to help participants by:
- Improving knowledge and understanding of the GLP principles and its regulatory basis ;
- Overview of current GLP status as well as achieving compliance with GLP regulations ;
- Understanding the requirements of a laboratory facility;
- Comprehensive information about documentations, such as Standard Operating Procedures, protocols, study plans, data quality and integrity, auditing, etc.;
- Covers key areas through programmes that integrate theory and practice
Module 1 : Introduction, fundamentals and principles of GLP
Module 2 : Documentation, records and preparation of SOPs
Module 3 : GLP compliance & preparation for certification; ISO / IEC 17025: 2017 & Laboratory accreditation
Module 4 : Internal Quality Audits for various Quality Management Sytems (QMS)
Module 5 : Use of Computers in the laboratory
Module 6 : General Good Testing Conduct
Module 7 : International GLP of the OECD, FDA etc
Module 8 : Management, Personnel, Buildings & Equipment
Module 9 : Method Validation and Quality Assurance
Module 10 : Inspection of a testing facility
Module 11 : Demonstration of Instrument Handling used in Pharmaceutical Laboratory
Module 12 : Case studies
On successful completion of this course, participants are expected to have better understanding of the requirements of GLP for the efficient working of a testing laboratory by applying the knowledge into practice. The course provides an overview of ISO / IEC 17025: 2005 as well as the common requirements of GLP Compliance (OECD & FDA) as applicable to various testing Laboratories and research organizations. This will also include recent developments related to computer validation.
Any Indian or overseas applicants must fulfill following criteria for enrolling into the one year Good Laboratory Practice program. The applicant must be a graduate in any discipline.
Minimum time in which a student can complete this diploma course is one year while a maximum of two consecutive years is allowed to complete the course.
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.
IGMPI follows a credit system based on all 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 timely submit completed assessment assignments (during the course, usually after every module) and appear for an online exam at the end of the course. After successful completion, the participants will receive a certificate of Post Graduate Diploma in Pharmaceutical Good Laboratory Practice by the Institute. For all the above mentioned modules elaborate course material, self-assessment assignments 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 participants of this programme have prospective career opportunities in clinical investigation, laboratory management, research, teaching, production, record keeping, technical writing and related activities. They can also work as medical laboratory scientists in diagnostic laboratories, pathology departments in government and private hospitals, pharmaceutical companies and research institutes. Those who are already working in these areas will be benefitted by the programme in terms of career enhancement and growth within the organisation or at the time of switching their organisations
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like