News about Quality / GMP

Zydus Lifesciences' Ahmedabad unit under USFDA observation

The inspection was conducted between September 23 to September 29, 2022

Quality / GMP | 30/09/2022 | By Sudeep Soparkar |  891

Lupin's Tarapur facility receives warning letter from US FDA

The company believes that the warning letter will not affect supply disruptions or current revenues from this facility's operations

Quality / GMP | 29/09/2022 | By Sudeep Soparkar |  659

Torrent Pharma's Gujarat facility gets three observations from US FDA

The inspection was carried its manufacturing facility at Indrad, Gujarat from September 19, 2022, to September 28, 2022
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Quality / GMP | 29/09/2022 | By Sudeep Soparkar |  392

Shilpa Medicare's plant in Telangana bags US FDA clearance

The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited (Parent Organization) and its agreed parties

Quality / GMP | 23/09/2022 | By Sudeep Soparkar |  860

China API plant banned by FDA for having no quality control in place

The batch testing that was performed was done over and over again, and only some of the results were recorded
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Quality / GMP | 11/08/2022 | By Sudeep Soparkar |  538

Strides Pharma successfully completes US FDA inspection at Singapore facility

The inspection was completed successfully with Zero 483 observations

Quality / GMP | 11/08/2022 | By Sudeep Soparkar |  927

Smoke study during material transfer

We have to prove that laminar airflow is maintained in the filling machine while doing various activities in the filling machine. Let's find out what are these activities.

Quality / GMP | 10/05/2022 | By Sudeep Soparkar |  921

Zydus under three observations from FDA

Indian-based pharma company Zydus Lifesciences just got hit with a triple whammy by the U.S. FDA.

Quality / GMP | 26/04/2022 | By Sudeep Soparkar |  624

Central Bureau of Narcotics directs exporters and importers to register on the ICEGATE portal

In its bid to speed up the customs clearance of import and export of narcotic drugs, psychotropic and controlled substances, the Central Bureau of Narcotics (CBN) under Union finance ministry has directed the exporters and importers to register on the ICEGATE portal. This is asked to avail the benefits of e-Sanchit services of the customs department.

Quality / GMP | 28/02/2022 | By Darshana |  474

BIS notifies Indian standards for various medical devices and health informatics

The Bureau of Indian Standards (BIS) has notified Indian standards for various medical devices and health informatics-related products and processes as part of its efforts to set standards including for medication related processes and electronic prescriptions, among others

Quality / GMP | 24/02/2022 | By Darshana |  511