FDA criticises SOP Training in pharmaceutical Companies

Since 2002, CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation) has been analysing annually FDA's Warning Letters to drug and API manufacturers. The results have also been published on behalf of the ECA. Over this 9-year period, interesting trends have been noticed.

Reviewing FDA's warning letters of the last fiscal year reveals that management and training of Standard Operating Procedures (SOPs) is still a hot topic. Besides non-compliance with own written procedures ("SOPs not followed", "you failed to comply with SOP") or insufficient procedures ("your SOP is inadequate", "SOP fails to …"), which are cited frequently, the main concerns refer to management and training, as the following excerpts show:

• "Your firm has not established appropriate written procedures"
• "There are documented instances of failure to follow SOP […] Employee Training"
• "Your firm's quality control unit failed to approve procedures"
• "SOP revisions are not performed and documented appropriately"
• "Your QCU did not date or approve two of your SOPs"
• "We recommend that you hire a qualified consultant to provide comprehensive CGMP training … . Further, we recommend that once the training is completed, you conduct a comprehensive evaluation of all of your written procedures to ensure they are adequate, complete, and in compliance with the CGMP regulations."
• "There are no records that show that CGMP training specific to the employees' duties was performed, as required by your SOP"
• "When presented with an unsigned SOP entitled "Training," which requires CGMP training of employees, both the GM and the Production Supervisor stated that they were unaware of this document."
• "In your response of […], you state that your firm will revise its training program to provide and track employee training in CGMP and specific job functions. This response is inadequate in that it fails to state when the training will be completed. It also fails to explain the measures you will take to ensure product quality while operations continue with employees not adequately trained."
• "You have not established completion dates and training programs for current good manufacturing practices and SOPs"
• "Your SOP and batch […] instructions are in English (the official language in Singapore). However, one operator who works in the processing of the plaster line for the finished product of […] cannot read English."

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)