15 Simple Tips for cGMP-Compliant Quality Systems

15 Simple Tips for cGMP-Compliant Quality Systems

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

Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission

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.

Upcoming Expertbriefings.com Webinars

• April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission
• April 16 – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, and 21 Tips and Tricks for Your Next Audit
• April 18 – Why You May Want to Move Your Pharma Company to Kansas – 483 and Warning Letter Trends
• April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
• April 29 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance
• April 30 – FDA Hands Out CAPA 483s Like Candy – Avoid Them With a Closed Loop CAPA System 
• May 1 – Avoiding Warning Letter Disasters With a Strong Contractor Quality Agreement
• May 7 – FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy

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