IGMPI India

October 7, 2015

October 7, 2015

PAN Drugs receives warning letter from USFDA

USFDA has recently issued a warning letter to PAN drugs Vadodara based plant due to significant deviations from good manufacturing practices.

MHRA issues recall notice of Lacri-Lube eye ointment

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice to Allergen Limited. The recall notice relates to 5g and 3.5g pack sizes of

Another Import Ban for Polydrug Laboratories

USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for

Health Canada lifts its ban from two Apotex facilities in India

Health Canada has lifted its ban from Apotex two Indian facilities. Canada’s drug regulator reinspected the two plants in June and determined

33 drugs were found to be of not of standard quality during Surprise inspection

Recently Karnataka drug control department had conducted surprise inspections to pick up drug samples at random. The drug test labs have issued their result.

Vivimed Labs successfully completes USFDA inspection of its manufacturing facility

Vivimed Labs has recently successfully completed inspection of its API manufacturing facility in Spain. After the completion of inspection Vivimed said “the USFDA inspectors concluded

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Numerous GMP deviations identified at Hebei Dongfeng Pharmaceuticals

EU GMP inspectors found 26 GMP deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals. As a result, a GMP Non-Compliance Report was issued and entered into the European database EudraGMDP.

The products affected were doxycycline hyclate and doxycycline monohydrate. According to EudraGMDP, a total of 26 deficiencies were found during the inspection. Out of them, the major ones were: not fully implemented Quality Assurance system, problems related to the documentation management, deviation related to material management and qualification of the approved supplier, risk of contamination in the production area & of testing samples and data recording and integrity in the QC laboratory were not in compliance.