By Mark Land, AAHP President

 

At AAHP, we firmly believe that compliance with quality and safety regulations is crucial for all homeopathic manufacturers. To educate our community, we’ve published content on preparing for the different types of FDA inspections, and last month I offered more insight into quality systems, one of the most cited problem areas.

Now I’d like to address more broadly how to prevent FDA warning letters and bad inspections. Many external tools can help, but the most important resource in stopping bad inspections in their tracks is much “closer to home” than you might first think—your people.

It’s true. Most violations are the product of human failure, whether that means unempowered staff, uninformed staff, or the need for new staff. Here are a few pointers to get your staff on board with compliance.

Senior Management Responsibility

Let’s begin with senior management. Here we can take a lesson from medical device legislation related to management responsibility. According to the Management responsibility section of 21 CFR 820.20(c):

“Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.”

First and foremost, the management team must be committed to sound quality principles, encourage a quality culture, and fund those projects accordingly. As with other organizational initiatives, it is management that must set an example by investing in quality and safety throughout the manufacturing process.

Staff Responsibility

When senior management espouses the importance of quality, that value can then flow down and throughout the organization. Some of the compliance tips I’d recommend at the staff level include:

  • Staff should be well qualified and encouraged to remain up to date on scientific and quality developments.
  • Permanent staff should be supplemented with advice from external experts routinely.
  • Quality and operations staff should be incentivized to comply with regulations.
  • Quality management plans should be informed by routine gap analyses.

Encourage and empower your staff. They are the first line of defense against warning letters and poor performance on your next FDA inspection.

Resources

I can recommend a couple of other resources and tools for inspection help.

First, look to the International Society for Pharmaceutical Engineering’s GMP Audit Checklist. It has seven multitiered sections intended to aid in the systematic audit of a drug manufacturing facility.

FDANews is also a great resource, not only for recent updates but also for compliance guides like their GMP Inspection Preparation Checklist.

 

By instilling a compliance-mindset into your people and using outside tools like GMP checklists to assess and minimize risk, you can put your company on the right path for a clean inspection. That’s good for you as well as our industry as a whole.