21 CFR 111.12: What personnel qualification requirements apply?
Requires dietary supplement firms to use qualified personnel, designate who is responsible for quality control with duties separate from their other roles, and ensure everyone has the education, training, or experience for their assigned functions.
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart B, Personnel
Recent 483s citing 111.12
- Miramar Cosmetics, Inc DBA Miramar Lab · Doral, FloridaPersonnel engaged in packaging, labeling and holding dietary supplements do not… Aug 31, 2022
- Hello Life, Inc · Kentwood, MichiganThe personnel you identified to perform quality control operations are not… Mar 7, 2019
The regulation text
§ 111.12 What personnel qualification requirements apply?.
(a)You must have qualified employees who manufacture, package, label, or hold dietary supplements.
(b)You must identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations.
(c)Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions.
Questions
What does 21 CFR 111.12 require?
Requires dietary supplement firms to use qualified personnel, designate who is responsible for quality control with duties separate from their other roles, and ensure everyone has the education, training, or experience for their assigned functions.
Which sections are cited alongside 111.12?
In the same 483s, investigators most often also cite 111.103 (What are the requirements under this subpart F for written procedures?), 111.105 (What must quality control personnel do?), 111.123 (What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?), 111.15 (What sanitation requirements apply to your physical plant and grounds?).