Thursday, February 11, 2010

Compliant and Correct SOPs for Clinical/Regulatory Trial, Study and Submission

Clinical and regulatory FDA and country regulations are not open to interpretation, however, both guidelines and guidances are negotiable with credible, literature and data based reason and rationale. Once SOPs are written, project leaders must ensure team and company compliance. Adherence to SOPs is critical to data, documentation and company integrity. FDA will not only review the long list of SOPs on audit, but will as well look for a record for proof of implementation, usability, enforcement and a tracking record of compliance throughout the company, project by project, clinical study by clinical study, clinical and regulatory submissions, one by one.

Points to Consider for SOPs:
  • areas where SOPs are useful (times when they are unnecessary)
  • appropriate outline for each SOP
  • what should not be included in company SOPs
  • training on SOPs to ensure team understanding and why the need for the procedure
  • when an SOP needs to be updated and why
  • standards for archiving SOPs
  • FDA access to your SOPs
  • involve FDA in your SOP compliance program - communicate.

Once a year, a pharma company must review/audit SOPs and related procedures in order to assess QC/QA issues and concerns before FDA does so, unannounced and for cause. Proactive, internal pharma audits must be routine and could be prompted much like an alert to generate an annual safety report. In this way, everyone, the team and the company are on board and the attention to SOPs and related activities become a scheduled company practice.

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