Mr. Ashok Kumar delivered a talk on the current good manufacturing practices (cGMP) on 15th December, 2018, addressing students of 1st M Pharm, Pharmaceutical Quality Assurance and Pharmaceutical Regulatory Affairs programs. He briefed the students on the history and need for good manufacturing practices (GMP) citing examples of sulfanilamide, thalidomide and other tragedies. He defined the term ‘quality’ and drew attention to the importance of GMP in pharmaceutical industries. He explained in detail about Pharmaceutical Quality System which ensures that significant parameters like change control, validation, quality management systems etc. are kept in check. He gave information about Quality Management and highlighted the fact that product quality reviews and annual product quality reviews are considered as the pillars of quality management. He also defined ‘risk’ and highlighted Quality Risk Management tools. He explained the requirements of different areas in the pharmaceutical industry such as the premises, equipment, training of personnel, personnel hygiene and sanitation. He also brought up seriousness of documentation practices, data integrity and ALCOA principles. He concluded the session by updating the students of the scope of their profession and also advising the students to be passionate about their profession.
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