DJC Workshop 1: "Quality and Regulatory Compliance of Pharmaceuticals -An Overview."

March 24, 2023


Centre for Drug Regulatory Affairs and Centre for cGMP organized the first MCOPS Diamond Jubilee Commemorative Workshop on Quality and Regulatory Compliance of Pharmaceuticals-An overview”. The workshop started at 9:30 am at Prof. P Gundu Rao Conference Hall, MCOPS, where all the participants and faculty members were present. Dr Krishnamurthy Bhat, Vice Principal, MCOPS, and Dr Girish Pai K, Associate Professor, Department of Pharmaceutics, gave a brief description about both Centres. The first lecture was delivered by Mr Ratish Acharya, Head-Quality, IDRS Labs Pvt Ltd, Bengaluru, who discussed the topic “Quality assurance from design to despatch”. The speaker was introduced by Ms. Athira R Nair, Assistant Professor – Senior Scale, Department of Pharmaceutical Quality Assurance. Dr. Ratish has an overall experience of 19 years in the Pharma Industry and has worked with reputed companies including Micro Advanced Research Centre (Microlabs), Plethico Pharmaceutical Pvt. Ltd., Nectar Lifesciences Ltd., Dr. Reddys, Aristo Pharmaceuticals Pvt. Ltd. His areas of expertise are Quality management systems, GMP, GLP, Audit and Compliance, and Analytical Research and Development. Mr Ratish Acharya was also successful in setting up full fledge analytical laboratories for two of his previous organization and was also setting up quality management systems. The session started with a discussion of Quality and its importance. Statistics of the 483s issued in the last five years were discussed in detail by the speaker. The reason for the drastic decrease in form 483s during the pandemic period due to COVID was analyzed, and discussed, and how such falls could be controlled. Mr Ratish also discussed the process of drafting the response to form 483s, and warning letters were addressed, along with its operational and financial impact on the markets were also analysed.


As the presentation progressed, Mr Ratish discussed the role of an auditor, who helps to ensure quality compliance to the standards. Some common mistakes made while implementing GAMP or audit trials include language barriers, lack of awareness, training, and an unfriendly system for the employee. Mr Ratish also mentioned the product recall trends and the order in which products getting recalled in the last five years. The presenter concluded his work by explaining the difference between qualification and validation.

The afternoon session for the workshop was addressed by Ms Sanyukta Tarode, Regulatory Specialist-GlaxoSmithline Pvt. Ltd., Bengaluru, who elaborated on the topic “Regulatory Submissions and Management”. She is currently serving as a Regulatory Specialist in GSK, Bengaluru. Ms Samyukta has handled the Submissions for developed and developing nations and also worked on National, Centralized, MRP, DCP submissions which include responses to queries, variations, renewals, PSUR's, MAA and various other submissions for European Union and MHRA. She also has experience with Publishing (eCTDXpress, Publisher), validation (Lorenz e-Validator) and other tools like ISI toolbox required for document and submission-level publishing. Apart from professional activities, Ms Samyukta has been in the lead roles of Toastmasters International since 2020. Her talk started with a detailed mentioning of different sections of regulatory departments in industry. She also mentioned the modules of CTD, specifically stressing module three, which includes Quality. The various components of CTD modules and CMCwere also discussed in detail.

The final section of the workshop was handled by Dr. Ramya Ravi, Department of Regulatory Affairs and Management, who took a hands-on live NDA/ANDA experience on PharmaReady eCTD & e-DMS Submissions Software. Dr Ramya Ravi started by introducing the delegates to the software. Electronic common technical document: the eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA's Centre for Drug Evaluation and Research (CDER) and Centre for Biologics Evaluation and Research (CBER). The presenter also mentioned the various steps involved in the operations of the eCTD software, navigation through the software, creating dossiers, attaching to each modules and steps involved in validation was discussed. All the sessions were interactive and was successfully concluded with gifting token of appreciation to the speakers and certificates to all the registered participants.