15 Simple Tips for cGMP-Compliant Quality Systems

15 Simple Tips for cGMP-Compliant Quality Systems

April 8th, 2013 // 4:02 pm @

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April 8, 2013

If you want to have cGMP-compliant quality systems in your pharmaceutical operation, here are some easy tips to remember:

SOPS

  1. Create a flowchart or process map before you start to assemble the language of the SOP.
  2. Try to write at an 11th grade or so level – people skim these documents. Use lots of bullets and subheads.
  3. Have no more than three approval signatures on any SOP.

Training

  1. Training is not done with Powerpoint slides.
  2. You need to test people for comprehension of the training provided, not just check that they attended.
  3. Train ALL personnel on your quality policy.

CAPAs

  1. More training will not usually solve a CAPA problem.
  2. Write up action plans as a checklist to make verification easier.
  3. Check any resolutions of CAPA problems within ninety days or less.

Audits

  1. Everyone makes 1-2 mistakes, but three will open a CAPA investigation.
  2. You should ask 10 why questions on a subject to get the answer
  3. Have an independent audit done every 24 months.

Risk

  1. Three categories of risk are enough for the FDA.
  2. Risk control DOES NOT EQUAL risk elimination.
  3. The longer you take to control risk, the more it is going to cost you.

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