Quality should not be tested in product but it should be built into the product
Says Dr Rubina Bose, Deputy Drugs Controller (India), CDSCO (WZ), Ministry of Health & Family Welfare, Govt. of India
New Delhi: Health and Pharmaceuticals Manufacturing & Medical Devices Committee in association with Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India organized a webinar on Scope of WHO-GMP Certification in Pharmaceutical Industry & Government support.
The Guests of Honour of the session were Dr. Rubina Bose, Deputy Drugs Controller (India), CDSCO (WZ), Ministry of Health & Family Welfare, Govt. of India & Prof. Ramesh Goyal, Vice Chancellor, Delhi Pharmaceutical Science & Research University.
The other eminent Panellists of the session were Mr. Pradeep Multani, Senior Vice President, PHDCCI, Mr. MukeshSinha, Advisor, Technical, Modi Mundi Pharma, Dr. D P Ghosh, Corporate Head, Technical & Scientific, Albert & David Limited, Dr. Ghulam Moinuddin, Team Lead, Freyr Solutions, Dr. Harvider Popli, Co-Chair, Health Committee, PHDCCI & Director, School of Pharmaceutical Science, DPSRU and the Session was moderated by Mr. Vivek Seigell, Assistant Secretary General, PHDCCI & Dr. Ravi Rathod, Deputy Secretary, PHDCCI.
While giving welcome remarks, Mr. Multani said that the GMP guidelines are designed to minimize the risk involved in any pharmaceutical production that cannot be eliminated through testing the finished product. He has mentioned about the five key elements, which are often referred to as the 5 P’s of GMP—people, premises, processes, products and procedures (or paperwork) and said that MSMEs should make sure to make their plants GMP compliant for the growth & to get into quality consistency especially in Pharmaceutical as it directly deals with the human lives.
Dr. Ramesh Goyal in his remarks said that there is a need to move at Pandemic Speed for Covid -19. The Government has taken exceptional measures for Covid 19 medicines and the regulators have speed up the regulatory approvals. He added that the country in witnessing the Biopharma revolution. He stressed that to boost the pharmaceutical exports; GMP is a must, since most countries accept import and sale of medicines only if it’s manufactured in GMP recognized plants. Dr Goyal mentioned that GMP has been fastest adopted by India as compared to other countries. While concluding his remarks he explained principles of GMP and WHO GMP is very important and the government support for the certifications.
Dr. Rubina Bose thanked PHDCCI for gathering all the stakeholders on one platform through this webinar and said that CDSCO ensured the availability of medicines during the covid times by giving approvals to various industry without compromising on quality of products. Dr. Rubina also said that the world is moving so fast with regards to the quality & safety of the products where quality should not be tested in product but it should be built into the product. She has also mentioned about various key areas of Good Manufacturing Practices like quality management system, good data and record management system, quality risk management and many more. She further said that one need to understand that what is the risk in your product and according to that one needs to respond. We need to adopt GMP standards to cop up with global market. She further said that there should be a corrective and preventive manufacturing system in every industry, Regulators are facilitators but proactive approach of the industry helps a lot.
Dr. D P Ghosh said that for pharmaceutical products, Quality, Efficacy and Safety are the key words. GMP as per requirement of WHO needs updating according WHO Guidelines which gets updated and modified through the TRS. He further said that all related to the Industry should be imparted training on regular intervals by industry experts and senior regulators. He also said that quality assurance is the most important factor today which keeps check on stages of procurement, testing, manufacturing operations and documentations are full proof.
Mr. Mukesh Sinha shared his views about importance of WHO-GMP certification in the pharmaceuticals Industry. He also mentioned about significance and need of maintaining data integrity for delivering consistent quality of the products. He also urged for various training programs/ sessions to be conducted for the Industry about WHO-GMP certification.
Dr. Ghulam Moinuddin thanked CDSCO for tremendous work done by them during the COVID times and said that regards coming from the world is because, we produce quality drugs starting from the procurement to end product. He said that no of WHO GMP certified companies are rising day by day in India and Industry needs to remember that it is a moving target and the industry needs to comply with it.
Dr. Harvider Popli gave a formal vote of thanks and said that there are eight elements of quality manufacturing where ethics and integrity are two basic principals which should be taught and understood during the academics and also at the start of their industry training.