Pharmaceutical Standards

Pharmaceutical Quality Standards are based upon regulations put forth in 21 CFR 210/211, “Current Good Manufacturing Practice for Finished Pharmaceuticals

These Quality Standards are established to comply with these regulations. The Food and Drug Administration (FDA) has issued several guidances and manuals that describe these standards.

 

Quality Standards include such areas as:

  • Contamination control

  • Testing

  • Training

  • Equipment

  • Document control

  • Change control

  • Manufacturing

  • Labeling

  • Cleaning and disinfection

  • And more...

A cannabis leaf with a snake climbing up the stem.
A cannabis leaf with a snake climbing up the stem overlaying organized files. "Pharma standards" overlays the image.

Pharma Standards

Companies must implement internal systems that comply with, and support, these Quality Standards.

 

When cannabis becomes federally legal, it is very likely that the new regulations will be based upon these Pharmaceutical Quality Standards. Our consortium of expert consultants can help you implement systems to comply with these standards and train your personnel on these systems. Don’t wait for the day when cannabis regulations are enacted. Contact us today!