FDA cGMP warning letters round up

By Nick Taylor

- Last updated on GMT

Related tags: Warning letter, Pharmaceutical drug, Control system, Control theory, Fda

in-PharmaTechnologist presents a round up of cGMP related warning letters issued by the FDA this week.

The US Food and Drug Administration (FDA) has recommended Contract Pharmacal ​engages a third-party consultant​ with appropriate current good manufacturing practice (cGMP) experience to assess operations.

In a warning letter sent to New York, US-based Contract Pharmacal the FDA recommends the consultant assesses the facility, procedures and systems on a routine basis. Assessing operations is intended to ensure products have appropriate identity, strength, quality and purity.

The FDA made this recommendation after listing alleged cGMP violations, covering process validation and stability data, which are similar to issues the agency cited at the plant in Hauppauge, New York, US since October 2000.

Belgium-based Qualiphar ​has received a warning letter from the FDA after the agency found its response to cGMP violations to lack sufficient corrective actions​. The warning letter responding to the actions outlined by Qualiphar in May was sent in September and published online this week.

Issues raised by the FDA regarding cGMP at the plant in Bornem, Belgium include: lack of adequate written procedures for production and process control; records not including the disposition of rejected filled drug product containers; and lack of adequate laboratory controls.

Kyowa Hakko Kogyo ​has received a warning letter from the FDA detailing cGMP issues​ found during a June inspection of its active pharmaceutical ingredient (API) plant in Yamaguchi, Japan.

Specific significant deviations from cGMP found by the FDA relate to: investigation and documentation of out-of-specification results by the quality control unit; maintenance of records for equipment cleaning; and use of a control system for issuance of laboratory records.

In May the FDA issued Jilin Shulan Synthetic Pharmaceutical ​with a warning letter​, published online this week, detailing cGMP issues found during an inspection of its API plant in Jilin Province, China.

The issues raised in the warning letter relate to: reporting and evaluating production deviations; facilities not being designed to minimise potential contamination; and rejection of APIs contaminated with foreign material.

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