A lot of people in my neighborhood, including me, are putting mulch in their landscaping beds around now. The Spring rains seem to kick in the weeds, which reminds people to re-mulch. That got me thinking of weeds that may grow in the Q system or in GMP. What might be an analogy to weeds growing?
Over the years, I have done many, many inspections and audits and “weeds” do typically appear in the Q system or in the GMP areas. Here are some I can think of: poor/missing maintenance of equipment and facilities, missing periodic revision of SOPs, CAPAs or Deviations open too long, personnel positions missing or open too long, inadequate GMP space resulting in mixups or cross-contamination, inattention to data integrity in the lab, poor training/retraining, to name some. So if these are the weeds, how do we get rid of them and what is the mulch?
Getting rid of weeds seems to be a full-time job, both in my garden and also in GMP. Since I don’t want to use chemicals in my garden, I have to be diligent about removing weeds by hand. Likewise, in GMP I’m often heard saying “Quality’s job is never done!” after outlining a remediation plan or commenting about some quality issue. Remediation is, of course, problem-specific, but then there is often a CAPA too, project management, tracking the progress and often tracking whether the CAPA worked or not (CAPA effectiveness). So sometimes the fix is straightforward, say hiring someone, and sometimes it’s a big involved project, like changing an HVAC system out.
The “mulch” to me is likely twofold: the PA or Preventive Action in a CAPA is meant to help prevent, or fully prevent a reoccurrence of the problem/issue. Therefore the PA part of the CAPA could be thought of as “mulch” preventing the weed. On another level is good management, and good forward thinking. Good managers always think ahead, sometimes 5, 10, even 20 years ahead, to prevent possible problems occurring. This is really hard to do, but at least we can plan a few years out. Quality Planning, though not strictly part of the Q system or GMP, is important to keep everything running smoothly, and management planning, like planning for new hires, and an increase in products or lot sizes, is equally important.
John is the Principal Consultant at JG BioConsult, and travels throughout the world helping biotechnology companies get ready for FDA Inspections, performing GMP audits, improving quality systems, and helping with BLAs and INDs and regulatory strategy.