Shredded paper, high temperatures, lax file access: US FDA releases Glenmark 483

By Flora Southey contact

- Last updated on GMT

GettyImages/Miyuki-3
GettyImages/Miyuki-3
The US FDA says it observed quality documents in the teeth of a staff room shredder and lenient computer access at Glenmark’s Baddi facility in India, which was issued a Form 483 last week.

The US Food and Drug Administration (FDA) inspected Glenmark Pharmaceuticals Limited’s finished formulations plant following a site inspection​ last month, and cited seven observations.

According to the Form 483​, the Agency found quality documents in the teeth of a shredder – which had not been recorded in the logbook for shredding, as per Standard Operation Procedure – in the firm’s Regulatory Affairs staff room.

The FDA also noted Glenmark’s warehouse lacked computer access controls, which meant unauthorised personnel could create and delete documents from the firm’s Quality Department.

 “We observed that a…warehouse employee was able to access/delete documents and folders that included, but not limited to: IPQA Data Donot [sic] Delete, Addendum to Operational Qualification Protocol Blister Packing Machine, Qualifications, and other quality documents,” ​reported the Agency.

According the Form 483, Glenmark’s data logger – which it installed to better understand shipping conditions – found drug products had been exposed to conditions outside permitted limits for more than 34 hours in storage, with the maximum exposure temperature logged at 44.5 ̊Celsius.

“Approximately 21 consumer complaints were received in 2016 and 2017 for this [exposed] product appearing to be “watery”…Your General Manager for Quality stated that phase separation occurs at elevated temperatures,” ​said the Agency.  

Glenmark had not conducted any evaluation to determine the impact of elevated temperatures on the drug product, and returned complaint samples were not “considered for any chemical evaluation by the quality unit,” ​the FDA added.

Elsewhere, the Agency said the firm failed to integrate written procedures related to the identity, strength, quality and purity of drug products for production and process controls, nor Stage III Continuous Process Verification (CPV) until last month.

The requirement to implement continuous process verification – designed to ensure commercial products remain in a state of control – was introduced in 2015, the Agency said.

Further, complaint records are deficient, reported the FDA, which told the firm its records failed to include the findings of investigations into returned drug products.

Glenmark did not reply to a request for comment, but in a letter filed​ with the Bombay Stock Exchange last week, said: “We are in the midst of providing a comprehensive response to the observations and would [sic] be replying to the FDA shortly on the observations.”

Related topics: Regulatory & Safety, Regulations

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