Regulatory Focus™ > News Articles > Warning Letter to Jubilant Focuses on Standard Operating Procedure Deficiencies

Warning Letter to Jubilant Focuses on Standard Operating Procedure Deficiencies

Posted 11 December 2013 | By Alexander Gaffney, RAC

Indian life sciences manufacturer Jubilant has been sent a Warning Letter by the US Food and Drug Administration (FDA) for current good manufacturing practice deficiencies reportedly found at the company's Spokane, WA contract manufacturing facility.

The letter, the existence of which had first been reported by the company last week, was made public on 10 December 2013 and references a lengthy inspection taking place between 15 April and 10 May 2013.

But if Jubilant is-like many other Warning Letter recipients this year-based in India, the similarities to other Warning Letters ends there. The majority of FDA's letter to the company has to do with the specifics of the standard operating procedures (SOP) manual, not the motley mélange of observations related to data fabrication and decrepit physical conditions that have plagued other Indian manufacturers this year.

Standard but Deficient

FDA's letter to Jubilant notes that the company's SOPs are deficient with respect to how it proposed to handle several potential situations. For example, the company's plan to maintain quality "during and after [a] shutdown" doesn't contain enough information to evaluate the impact of the shutdown on its operations. A shutdown can cause some sterile areas to require re-sterilization before resuming, and if a batch of product is in the middle of processing, it might need to be discarded.

FDA noted that the firm had indeed shut down temporarily in April 2013 to conduct some physical upgrades to the plant, but had failed to ensure that standards had been maintained in certain ISO-certified areas before resuming operations. In addition, FDA said the company failed to evaluate the impact of the upgrades on its manufacturing operations.

The upgrades were also faulted by FDA inspectors as lacking quality assurance oversight despite that being an explicit requirement of its SOP. In addition, work orders were not properly documented in some cases.

In another case, FDA said the company's SOPs lacked detail with respect to cleaning and sanitation measures. The SOP "lacks adequate details on how many times mops and wipes can be used," the letter states. The company subsequently failed to include a scientific rationale for its proposed number in its response to FDA, the agency maintained.

Lack of Investigation

But in another case, the company failed to properly investigate "unexplained increased levels of unknown [redacted] impurities." Jubilant had withdrawn those products from the market and altered their expiry dating-correctly, as FDA notes-but subsequently failed to implement corrective actions or implement a root cause analysis.

FDA said that, in total, the alleged deficiencies caused inspectors to "question the effectiveness of your current quality system to achieve overall compliance with CGMP at your facility."

"It is apparent that you have not implemented a robust quality system at your firm," FDA concluded. The company was advised to conduct a global assessment of its manufacturing operations to ensure compliance elsewhere and given 15 days in which to respond.

Focus has reached out to Jubilant for comment and will update this piece if it responds.

Warning Letter

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