cGMP: SOP Management and Training criticised by FDA

Since 2002, CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation) has been annually analysing FDA's Warning Letters to drug and API manufacturers. The results have also been published on behalf of the ECA. Over this 10-year period, interesting trends have been noticed.

Reviewing FDA's warning letters of the last fiscal year (2011) reveals that incompleteness, management and training of Standard Operating Procedures (SOPs) is still a hot topic. Besides non-compliance with own written procedures ("failed to follow SOP", "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 incompleteness, management and training, as the following excerpts show:

• "You have not provided a revised SOP"
• "Your firm has failed to validate your Standard Operating Procedure (SOP)"
• Your firm failed to establish written procedures used in the manufacture of drug products
• "The document that was provided to our investigators entitled […] appears to be an operating manual as opposed to a standard operating procedure that can be easily followed by your operators"
• "Your firm failed to provide a justification for deviating from your SOP"
• "The employees of your firm, including a member of your quality control staff, admitted to our investigators that they were unaware of and were not trained to follow your SOP"
• "Your firm states that additional training will be provided concerning SOP […] You have not provided a detailed explanation of your corrective actions or a timeframe of completion"
• "You have not yet provided this SOP"
• "Your response fails to specifically address how the proposed training will ensure that all employees will be trained in SOPs that are relevant to their job functions"
• "Your response fails to include timeframes for completing training"
• "Your firm has failed to address the employee training regarding the two revised Standard Operating Procedures"
• "You have not defined what specific information will be included in your CGMP training"
• "Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience"
• "Your response fails to specifically address how the proposed training will ensure that all employees will be trained in SOPs that are relevant to their job functions"
• "Your response fails to include timeframes for completing training"

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