. GMP Deficiencies in Vital Laboratories Limited

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GMP Deficiencies in Vital Laboratories Limited

In pharmaceutical Industry, GMP violations are unacceptable and depict a manufacturer’s lax handling of deviations, insufficient monitoring and documentation of critical process steps as well as their ignoring of OOS results in quality control. In April 2017, FDA inspectors were confronted with these violations when they visited the production site of an Indian manufacturer Vital Laboratories Private Limited.

Following inspection, FDA issued a warning letter to the manufacturer citing all the deficiencies in detail and non-GMP compliant procedures of the personnel in several steps of production and quality assurance.

In-process controls The tests have not been performed for several batches without justification, despite the in-process controls for active ingredient content.

Documentation of critical process steps using the dual control principle Batch records did not contain signature fields for the documentation of critical process steps by two people. However, in cases where those fields existed ("done by"; "checked by"), like in weighing operations, the fields were verified by the same person. Inspectors marked this as non-GMP practice and noticed very common among production facility

Investigation and documentation of OOS results; CAPA measures Analytical content determinations provided OOS results which were ignored. Root cause analysis was not performed; rather, the results were used as a basis to assign expiration dates.

Annual product review The FDA inspectors reviewed the report which contained the same stability data as the one from the previous year. Mean values for important quality attributes of APIs such as water content, impurities and optical rotation were wrong as they exceeded the specified maximum values. Furthermore, some mean values reported only referred to a single batch.

The Vital Laboratories Ltd acknowledged the errors cited by the FDA inspectors and confirmed to take corrective actions.

Finally, the Warning Letter stated that similar GMP deficiencies had been found in earlier inspections of other Vital Laboratories sites. The FDA therefore deems the company's quality management over all sites as ‘insufficient’.



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