In order to sensitise Indian companies regarding falsified, non existent or destroyed records which leads to violation of GMPs, regulatory experts recommend the need for developing and maintaining electronic data as paper records can easily be lost, damaged or cannot be validated for accuracy.
As per the US FDA guidelines, effective documentation procedures must ensure not only the quality of the recorded data but also security of the records and the validity of the signature (electronic records must comply with 21 CFR Part 11). Pinpoints compliance and regulatory expert Scott Bernard, “The paper based records poses several risks in audit accuracy and also raises issues of security and validation.”
According to experts, this has become more imperative with the implementation of new laws including the US Food and Drug Administration Safety and Innovation Act (FDASIA). Says S M Mudda, executive director, Micro Labs, “Dr Reddy’s have already started some electronic documentation in modular and phased manner. Micro Labs is also moving towards the same process with the introduction of an automated warehouse management system.”
Taking note of compliance and scalability issue, many Indian companies, alike global multinationals such as Teva Pharmaceutical Industries, Johnson & Johnson, are interested to move from manual system to an electronic system. Says Ellen Leinfuss, SVP, UL EduNeering, an online global regulatory learning solution provider, “We started the process of educating companies about electronic documentation a few months back and 6 to 8 Indian companies have shown interest so far with us."
The curriculum and the FDA authored suite of courses on GMP, cGMP, GCP and QSR, offered by UL EduNeeering, is designed to address training needs through services in India and include immediate and long term relevant topics related to international inspections, import and export of products and global compliance etiquette.
Sharing her views on electronic documentation, regulatory expert Dr Kavita Mehrotra says, “I have had a chance to meet with several heads and leaders of large and mid-size Indian pharma companies in the past couple of months. Most Indian companies are struggling to understand the specifics of global compliance expectations, ranging from the need for appropriate documentation, to electronic records, to visibility and empowerment of QA groups.”
Online regulatory and compliance solution is one very reachable way of offering consistent articulate electronically available training to all the employees regardless of their geographical location. This expertize and its accessibility comes as a much needed and timely knock on the door for Indian pharma industry, which is ripe for standardizing training channels and stacking up to expectations of global standards.
Dr Mehrotra concludes, "Global GMP processes are not only feasible, but very learnable and time tested. There is a need to offer the Indian pharma companies effective, actionable training strategies, tools and content, to demonstrate and observe regulatory compliance.”