INDIA. Mumbai: Intending to educate all those engaged in drug manufacture, testing samples in laboratories and others related to pharmaceuticals, the Maharashtra Food and Drugs Administration (FDA) has decided to organize a series of interactive workshops involving the public laboratories and its staff as part of the 75 th anniversary of Indian Independence.
In these workshops, those working in testing laboratories will be exposed to newer modern instruments and the importance of conducting an audit of the work from time to time so that the mistakes if any, could be rectified well within time. Similarly, an emphasis will be laid on strict adherence to the Good Manufacturing Practices (GMP) so that the Indian medicines can be competitive in the international market, Girish Hukare, Assistant Commissioner Maharashtra FDA told the “Transcontinental Times”.
More workshops on different topics involving drug makers, medical device manufacturers, pharmacists, and others, will be organized as part of the Amrit Mahotsav (75 th anniversary of Indian Independence) throughout the state, Hukare added.
The growing demand for effective medicines calls for effective reliable medicines that are safe and are of standard quality. In keeping with this objective, the first interactive workshop was organized by the Maharashtra FDA jointly with “QbD Research & Development Lab Pvt Ltd” in Thane, near Mumbai on Monday. The workshop was chaired by Assistant Commissioner Girish Hukare, who was also the chief guest on the occasion.
The workshop was organized to ensue “Drug Safety and Quality in public testing laboratories”. The QbD Research & Development Lab Pvt Ltd, equipped with modern state of art technologies is accredited by FDA, Maharashtra, US FDA, and National Accreditation Board for Testing and Calibration Laboratories (NABL). Given the capacity building of staff, attendees included nearly 18 Food and Drugs Inspectors from different parts of Maharashtra.
The workshop focussed on the importance of public testing labs as well various other topics including current Good Manufacturing Practice (cGMP), Quality by Design, and 21 CFR Part 11 compliance. The Code of Federal Regulations (CFR) deals with governing food and drugs. 21 CFR Part 11 states that electronic records and electronic signatures are treated the same as paper records and handwritten signatures. Regulated companies with any documents or records in electronic format must comply with the regulation. It applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions.