Subpart E. 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 is not met?
- § 111.95 - Under this subpart E, what records must you make and keep?