US-based safety consulting and certification firm Underwriters Laboratories (UL) has inked a pact with Gujarat Government to train the state's Food and Drug Control Authority inspectors on audit regulations.
The company has signed a memorandum of understanding (MoU) with the Gujarat government to train Gujarat Food and Drug Control Authority (FDCA) inspectors, UL said in a statement.
"UL will be using specially designed online programs in keeping with international regulatory guidelines, to help ensure the quality and safety of pharmaceuticals manufactured in Gujarat," it added.
UL EduNeering, the compliance education and training services business division of UL Life & Health, will lead this initiative, UL said.
The goal of this effort is to empower the Gujarat FDCA (Food and Drug Control Authority) investigators with the same source of knowledge that is currently accessible to U S Federal Drug Administration (USFDA) investigators, UL said.
Commenting on the development, UL EduNeering Global Strategic Head Kavita Mehrotra said: "Through this strategic partnership with Gujarat FDCA for the first time in India, UL aims at bringing in good manufacturing practises (GMP) by empowering the regulatory authorities with the right kind of training which would enable them to guide drug manufacturers in adhering to necessary standards."
From a strategic perspective, this is very important, because ultimately, not only does this will contribute significantly to patient safety but also influences the quality of exports of pharmaceuticals and other related products, thereby accelerating business results as well, she added.
"UL EduNeering's rich modules of training programs that are followed by USFDA would definitely help our inspectors understand the nuances of global regulatory requirements and ensure a high degree of quality control for pharmaceutical manufacturers in Gujarat," Gujarat FDCA Commissioner H G Koshia said.
UL EduNeering is a business line within UL Life & Health's Business Unit. It has an exclusive partnership with the USFDA and has trained over 36,000 FDA inspectors and investigators, UL said.
