21 CFR Part 111, Subpart E - Requirement to Establish a Production and Process Control System
- § 111.55 What are the requirements to implement a production and process control system?
- § 111.60 What are the design requirements for the production and process control system?
- § 111.65 What are the requirements for quality control operations?
- § 111.70 What specifications must you establish?
- § 111.73 What is your responsibility for determining whether established specifications are met?
- § 111.75 What must you do to determine whether specifications are met?
- § 111.77 What must you do if established specifications are not met?
- § 111.80 What representative samples must you collect?
- § 111.83 What are the requirements for reserve samples?
- § 111.87 Who conducts a material review and makes a disposition decision?
- § 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?
- § 111.95 Under this subpart E, what records must you make and keep?