Thursday, 22 January 2015 MHRA withdraws GMP Certificate for all APIs of Wockhardt. The UK regulator MHRA has updated its statement of noncompliance to include all APIs made from the India-based manufacturer Wockhardt. The company has decided to stop shipment of all API to the EU. In 2013 US FDA in banned products from Chikalthana site of Wockhardt after the MHRA withdrew the site’s GMP certificate following non-compliance. According to MHRA a critical deficiency was cited with regards to data integrity of GMP records, entries were seen to be made when personnel were not present on site, documentation was seen that was not completed contemporaneously despite appearing to be completed in this manner. Theregulator also cited the company for potential product contamination, as well as inappropriate pressure differentials that were not in line with the original design but had not been changed using change control, cleaning validation that was not sufficiently robust to confirm cleaning practices and maintenance issues, such as the failure to spark test glass lined reactor vessels for integrity especially following maintenance. The blanket statement covering all of the APIs was added onto a GMP non-compliance report issued for the company’s Chikalthana site. The initial statement of serious non-compliance permitted continued supply of critical APIs. The statement of non-compliance was updated to cover all active substances in January 2015 . The agency will require a re-inspection of the company’s Chikalthana, India site by an EU national competent authority prior to gaining approval to supply the EU market in future.09:39 Friday, 23 January 2015 FDA bans products from IPCA as corrective actions not satisfactory. The FDA has banned imports from IPCA Laboratories Ltd , citing violations of standard production practices. Last July Ipca suspended shipments to the United States from the plant at Ratlam in Indias central state of Madhya Pradesh that makes drug ingredients, after the FDA outlined half a dozen violations, including data integrity issues. IPCA was caught red handed with data manipulations and data integrity issues. A review of the Form 483 issued to the company by FDA reveals serious lapses by the company on data integrity requirements and therefore the company had on its own stopped exporting products to the US. Based on the FDA citation the company changed the date and time setting on a controlling PC of a Gas Chromatograph on July 18, 2013 to read the date as June 12, 2013. After the resetting of the date a few chromatograms for a finished API batch were reprocessed by changing integration parameters and results were reported as passing results. The FDA reviewer reprocessed the chromatograms with original integration parameters. The results so obtained did not meet the specifications. This clearly demonstrated that the time and date setting was reset so that results could be manipulated so as to meet specifications. A QC analyst confessed to the FDA reviewer that integration parameters are changed and results are recalculated to obtain passing results.Similar observations were made in case of a stability batch which involved analysis of residual solvent. In this case also the date and time clock were reset; chromatograms were reintegrated with different parameters to obtain passing results. In this instance also when the FDA reviewer used original parameters failing results were obtained.A standard injection was injected again and the results of the new standard overwrote the results the initial results. Again raising suspicion of a data fraud.In another instance data integrity issues were found in a HPLC analysis of a finished API batch which was released for commercial distribution. In this instance raw data files of standards were manipulated to obtain passing results.Data manipulation was observed in case of HPLC analysis of another API , wherein data was deleted to conceal original results.FDA then concludes following data integrity issues in analytical laboratoryManipulation of the controlling PC time/date setting using administrator privileges Manipulation of integration parameters to achieve passing resultsAborting ongoing sample analysis and deleting resulting raw dataOverwriting previously collected raw dataSimilar lapses were found in microbiology laboratory.Samples purported to be incubated were not present in the incubator. During the audit a microbiologist created an additional falsified plate to make it appear that the sample was present.During the audit the FDA reviewer observed two analysts actively back dating temperature record log books of refrigerators used to store a variety of cGMP materials.In another instance an investigation for a power outage showed that a particular incubator did not have any samples. However in reality growth promotion samples were present during this time. Again data manipulation issue. Ipca had said that it is working closely with FDA to resolve the issues. However the action by IPCA does not appear to be satisfactory hence the ban. Earlier data integrity issues at Indian drug and ingredient makers have revolved around the deletion of electronic data, the concealment of data on failed tests, the fabrication of records and test repetition to ensure satisfactory results. Canada, Europe and Australia are among Ipcas other global markets. Exports accounted for about 63 percent of sales in the financial year that ended on March 31, its website shows.
Posted on: Sun, 25 Jan 2015 05:15:57 +0000
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