GMP is a critical concept in pharmaceutical industry. According to World Health Organization (WHO), Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled, according to quality standards. Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical GMP regulations and other quality standards. This Programme offers knowledge of basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.
• Introduction to Good Manufacturing Practices
• The Requirements of GMP, ISO 9000 and their inter-relationship
• Audit and Audit Preparation
• Auditing Systems: Training, Internal Audit, Management review, Deviation, Complaints, CAPA
• ICH Q8, Q9, Q10 and their role in Pharmaceutical Industry
• ISO 19011 and 21 CFR Part 11 Guidelines for Auditing
• Auditing the Warehouse, Production, Packaging and Laboratories, Sterile Manufacturing Facility
• Good Manufacturing Practices and its Regulations (International perspective)
• Computer System Validation
Graduation in Pharma/Medical/Biomedical/Biotechnology/Microbiology/Science and Candidates appearing for the final year of Bachelor's degree/equivalent qualification exam or awaiting their results, are eligible to apply.
The registration dates for this certification run by the institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the certification lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants. After registration confirmation by the institute, required study resources, assessment test papers will be dispatched to the participants. This study material is considered sufficient for the preparation of the certification exam. However, the participants should feel free to go through other study resources and resources as well. The certification examination will be notified after 2 months of the registration.
Rs. 20,000/- for Indian nationals and 600 USD for overseas Professionals. This covers the certification registration fee and examination fee. An additional membership fee of Rs 4500/-( USD 125 for overseas) is to be paid in order to avail the services of Certified Study Resources and training for the preparation of the certification exam.
All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be awarded the professional certification of "Certified Pharmaceutical GMP Auditor" by IGMPI. All the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process.
In case the participant is not able to pass the certification exam in first attempt/exam notification, he/she will have to re- register for the next scheduled examination by submitting re- registration form along with the re- registration fee of Rs. 1500/-(50 USD). However, the participants will be given sufficient flexibility in scheduling their “First” certification exam.
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. 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 and Food industries on regular basis.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like