'Rough notes' and backdated signatures land Indian API maker US FDA warning

By Dan Stanton

- Last updated on GMT

Gujarat, India-based Mahendra Chemicals slammed with US FDA warning letter
Gujarat, India-based Mahendra Chemicals slammed with US FDA warning letter

Related tags Manufacturing Pharmaceutical drug Food and drug administration Fda

Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.

Mahendra Chemicals manufactures active pharmaceutical ingredient (API) and specialises in the local anaesthetic product lidocaine. But an inspection by the US Food and Drug Administration (FDA) at its Ahmedabad, Gujarat production plant in May 2014 has led to the company receiving a warning letter for deviating from current good manufacturing practice (cGMP).

The letter​, dated earlier this month, highlighted a number of violations, including the failure to record activities at the time they were performed and the destruction of original batch production records.

“Our investigators found that some of your operators used ‘rough notes’ (unbound, uncontrolled loose paper) to capture critical manufacturing data and then destroyed these original records after transcription into the batch production records,”​ the FDA letter says.

“We interviewed employees during the inspection who confirmed your firm’s practice of transcribing data to batch records and destroying original records.”

Furthermore, the agency found discrepancies with production review records, including backdated batch production records from February 10 to 25, 2014, signed by the Technical Director who was not in the facility when during these dates.

While the FDA said these batches were not destined for the US, it notes that Mahendra’s “failure to assure proper review of production and control records before product release raises questions about the authenticity and reliability of your data and the quality of the APIs you produce for the US market.”

A spokesman for Mahendra refused to comment on the impact of the letter or remediation plans when contacted by in-Pharmatechnologist.com.

Failings in training

The agency also pulled the API maker up on failing to prevent unauthorised access or changes to data, and failure to provide adequate controls to prevent the omission of data, while it also questioned Mahendra on its training of employees in relation to cGMP practices.

“In interviews, multiple employees stated that they had not received on-the-job training for their production operation,”​ the letter states.

“There was no record of training for the GC analyst testing for residual solvent release in final API,” ​and while the firm’s ‘training programme’ was supposed to generate a report for each trainee, Mahendra was unable to provide any of these to investigators during the inspection.

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