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US FDA issued warning letter to Wockhardt’s Ankleshwar plant.

US FDA issues a warning letter to Wockhardt for significant violations in manufacturing practice norms, including its Data Integrity issues, API sterility violation and improper clothing for workers at its Ankleshwar plant in Gujarat.

In the letter to Wockhardt chairman and group CEO Habil Khorakiwala, the US FDA said inspectors during inspection from 7 to 15 December 2015, found “significant violations” of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals as well as for active pharmaceutical ingredients (API).

US FDA has already banned import of products from the facility into the US market since 5 August 2016.

Elaborating on the violations at the plant, US FDA noted that the company failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination.

“Our investigator observed employees working in gowns that had unravelled stitching extending from hoods, zippers, and pants. Your firm approved these gowns for operations…you should have discarded these garments,” it noted.

USFDA finds the Firms response is inadequate because it does not include the assessment of washing, drying, ironing, sterilizing, or other operations that may contribute to sterile garment damage.

It also does not address the need to limit the number of sterilizations. FDA investigator noted that firm sterilize gowns numerous times. These excessive sterilizations lead to breakdown of gown fibers.

The other violations include the firm’s failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile and that include validation of all aseptic and sterilization processes.

“Under dynamic conditions, air did not sufficiently sweep across and away from sterile connections, so the sterility of any product processed under these conditions could be compromised,” US FDA said.

The investigator identified air flow disturbances and turbulence during the airflow analysis (smoke study).

Besides, the inspectors identified multiple aseptic technique breaches during aseptic connection of the equipment.

“Your equipment design and aseptic processing operator competencies appear to contribute to the lack of unidirectionality.”
Even operations that have been successfully qualified can be compromised by poor operational, maintenance, or personnel practices.the health regulator said.

Also, the firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards,
The firm did not investigate OOS result or explain why the failing result from the official record were excluded.US FDA said.

The firm also failed to exercise appropriate control over computer or related systems to assure that only authorised personnel institute changes in master production and control records.

Commenting on the API production issues, US FDA said the company failed “to record activities at the time they are performed, and destruction of original records”.

Besides, the inspectors identified some data integrity issues including:
Failure to record activities at the time they are performed, and destruction of original records FDA said.

Investigator found several unofficial notebooks (Personal Diaries) recording sample preparation for OOS investigations, route-of-synthesis experiments, and scale-up data also investigator found discrepancies between these unofficial notebooks and the official data retained by firms quality unit. USFDA said.

Investigator found many CGMP documents including torn and shredded equipment maintenance documents, raw material labels, and change control work orders in your scrap yard awaiting incineration. USFDA mentioned in warning letter.

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