News about GMP/cGMP

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.

Source:

FDA: Warning Letters recently posted, subject cGMP