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Manipal Academy of Higher Education (MAHE) has established a Centre for current Good Manufacturing Practices (cGMP) at Manipal College of Pharmaceutical Sciences in Manipal.
Quoting Girish Pai Kulyadi, coordinator of the centre, in a media release said, “There is a huge industry-academia gap with respect to GMP concepts in academic curriculum and actual industry practice, and therefore academia has a major role to inculcate a strong GMP foundation in young brains.”
He said the centre shall be rolling out well defined achievable objectives that will benefit the pharma students and technical staff at pharma companies.
The cGMP centre shall be assisted by a five-member in-house team from academia and two experienced industry experts. The in-house team includes Girish Thunga, Muddukrishna BS, Arvind Pai, Vasudev R Pai, Ravindra U Shenoy. Mentors from pharma industry include Harish K Jain, Director of the Bengaluru-based Embiotic Laboratories (P) Ltd, and G Sundar, Director at the Chennai-based PharmQA Compliance Services.
Jain said the recent audit outcomes of various global regulators reflect that building a strong quality culture and data integrity systems is the need of the hour, especially for the Indian pharmaceutical sector.
Stating that both quality culture and data integrity go hand in hand, he said these good practices should be inculcated into young minds right from academic setup so that fresh candidates entering regulated pharma companies are well versed with the GMP practices and know the importance of data integrity and various challenges associated well in advance.
He said Centre for cGMP shall be working towards mitigating these lapses right from academic setup and this will definitely bring a positive change in the thinking of freshers joining a regulated company.
The cGMP is the part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as per design specification.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous.
Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure and fines, the release said.
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