Requirement to Establish a Production and Process Control System

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Food for Human Consumption
  6. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
  7. Requirement to Establish a Production and Process Control System

Checkout our iOS App for a better way to browser and research.

Section
111.55

What are the requirements to implement a production and process control system?

Section
111.60

What are the design requirements for the production and process control system?

Section
111.65

What are the requirements for quality control operations?

Section
111.70

What specifications must you establish?

Section
111.73

What is your responsibility for determining whether established specifications are met?

Section
111.75

What must you do to determine whether specifications are met?

Section
111.77

What must you do if established specifications are not met?

Section
111.80

What representative samples must you collect?

Section
111.83

What are the requirements for reserve samples?

Section
111.87

Who conducts a material review and makes a disposition decision?

Section
111.90

What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?

Section
111.95

Under this subpart E, what records must you make and keep?