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News about GMP/cGMP


FDA Warning Letters to Chinese, Australian and Austrian Drugmakers

This week the US FDA (Food and Drug Administration) has already released five warning letters, all dealing with significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and APIs. Following is a short summary of the various findings:


Shanwei Honghui Daily Appliance, Shanwei, China, inspected from July 31 to August 3, 2017.

  • A failure in cleaning, maintaining , sanitising and sterilising of equipment and utensils was determined
  • Written procedures for production and process control were not followed and process features were not documented while running
  • There was no performance of batch laboratory determinations or microbiology tests
  • No testing of incoming APIs or excipients
  • No batch production and control records could be provided as there was no batch record performed for each batch.

Delta Laboratories, Somersby, Australia, inspected from March 27 to 31, 2017

  • Unexplained discrepancy or failure of a batch was not thoroughly investigated
  • Written procedures for production and process control were not established
  • Adequate written testing program was not followed or even in place
  • The Quality Unit is not fully exercising its authority or responsibilities
  • No adequate process validation studies available.

Yicheng Chemical Corporation, Changzhou, China, inspected from July 17 to 21, 2017

  • Failure to manufacture, weigh and repackage drugs and APIs in separate facilities which results in an unacceptable high risk of API cross-contamination
  • Failure of Quality Unit to review batch production records prior to distribution of an API batch
  • Failure of complete traceability of API in commercial distribution.

Wuhan Chinese Moxibustion Technology, Wuhan, China, inspected from May 22 to 26, 2017.

  • Lack of adequate Quality Control Unit
  • No master production and control records were prepared
  • No laboratory controls were established
  • No adequate written procedures for production and process control in place
  • A failure in cleaning, maintaining , sanitising and sterilising of equipment and utensils was determined.

Schrofner Cosmetics, Salzburg, Austria, inspected from July 17–19, 2017.

  • Lack of adequate Quality Control Unit and no written procedures for process- and cleaning validation and other manufacturing operations
  • No master production and control records were established
  • Finished drug products were released without testing of identification and strength of the API.

FDA: Warning Letters recently posted, subject cGMP
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