45 state inspectors to be trained on US FDA’s GMP g’lines
Underwriters Laboratories (UL), the global safety science company, for the first time in India, will be implementing a training programme for the Gujarat Food and Drug Control Authority (FDCA). UL will train their inspectors using a specially designed curriculum that will be conducted online.
The training will be conducted initially for 45 inspectors from the Gujarat FDCA in the first phase with 20 online modules as a part of the curriculum. The vision is to have the Gujarat FDCA at par with the USFDA guidelines, especially in terms of audit regulations and guidance and to educate the inspectors on good manufacturing practices (GMP) thereby improving exports of pharmaceuticals and other related products.
According to Dr Kavita Mehrotra, Global Strategic Head, UL EduNeering, the first of these sessions was conducted on December 19 last year and the agreement was signed during Vibrant Gujarat with Dr HG Koshia, Gujarat FDCA Commissioner.
The company is in talks with other states as well and she indicated that it is their belief and hope that other states will follow Gujarat’s initiative.
Mehrotra indicated that a few mid sized and small pharma companies have reached out to them for their advisory services, both as a preventive as well as a remedial measure. Hoping that this too would pick up, she said, “It is hoped that in time, both sides (regulators as well as the regulated, i.e. pharma companies) will speak the same language.”
UL’s training arm, UL EduNeering has an exclusive partnership with the US FDA and has trained over 36,000 FDA inspectors and investigators.
EP News Bureau – Mumbai
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