Following the US FDA's workshops on GMP and CGMP compliance for the first time in four cities of India in partnership with Central Drugs Standard Control Organisation (CDSCO), the US-based online compliance and regulatory learning solutions company Underwriters Laboratories (UL) Eduneering is planning to conduct a series of training programmes to equip Indian pharma on knowledge, tools and processes for audit readiness. UL Eduneering is a knowledge partner of USFDA on GMP, CGMP and Quality Management System.
The US FDA –CDSCO workshops covered relevant topics for Indian regulatory requirements like process validation, enforcements and computer system validation based on out of specific information. The workshops were held in Hyderabad, Goa, Chandigarh and Ahmedabad.
UL Eduneering has the distinction to have trained 36000 USFDA drug regulators through its GMP, cGMP, enforcement and Inspection focused courses authored by FDA and developed by UL Eduneering.
Dr Kavita Mehrotra, Global Strategic Head, UL was one of the attendees at the Goa workshop. The US FDA-CDSCO workshop, she said, was the first step towards having a shared knowledge about GMP and Quality Management Systems. “UL Eduneering will continue to act as a global thought leader in the area of GMP and CGMP, GCP and Learning Management Systems and looks forward to strengthening these ongoing efforts of US FDA to serve the India pharma community. We will be offering our next workshop in July to be held in partnership with IDMA in Mumbai, where we will take this commitment that we share morally and professionally with FDA to the next level. In this workshop, we will be offering quantifiable tools in the form of validated LMS, ComplianceWire, advisory and audit readiness expertise, to help retain the knowledge laid down in the US FDA workshops.”
Additionally, this workshop will focus on actionable steps that need to be taken, audit readiness and basics of inspections through a thematically, strategically and ethically aligned focus with US FDA and MHRA recommendations.
This will enable Indian pharma companies on compliances related to consent decree, Form 483, data integrity and quality management systems. This would also provide knowledge nuggets and best practices on maintenance of electronic records for inspection-readiness of Indian companies.
Dr Margaret Hamburg, Commissioner FDA, had made a commitment in her visit to India in February this year to launch a set of workshops to bring the knowledge of global GMP standards to the Indian pharma.
"Considering the fact that certain Indian companies have got critical global attention due to certain evasions, violations and avoidances during US FDA inspections, compliance is required for development of closed systems which captures electronic signatures, audit trails and any changes made in the system or content and also simultaneously offer, track, record and report at the same time. This is in accordance to 21 CFR Chapter 11 compliance of US FDA guidelines," Dr Mehrotra pinpoints.
To serve compliance and regulatory needs of the fast growing life science community in India, UL and US FDA have also extended their Cooperative Research and Development Agreement (CRADA) for five additional years, extending this exclusive agreement until 2019.