Federal (United States) · Regulations
Subpart E — Requirement to Establish a Production and Process Control System
12 sections
12 sections
- 21 C.F.R. § 111.55What are the requirements to implement a production and process control system?
- 21 C.F.R. § 111.60What are the design requirements for the production and process control system?
- 21 C.F.R. § 111.65What are the requirements for quality control operations?
- 21 C.F.R. § 111.70What specifications must you establish?
- 21 C.F.R. § 111.73What is your responsibility for determining whether established specifications are met?
- 21 C.F.R. § 111.75What must you do to determine whether specifications are met?
- 21 C.F.R. § 111.77What must you do if established specifications are not met?
- 21 C.F.R. § 111.80What representative samples must you collect?
- 21 C.F.R. § 111.83What are the requirements for reserve samples?
- 21 C.F.R. § 111.87Who conducts a material review and makes a disposition decision?
- 21 C.F.R. § 111.90What 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?
- 21 C.F.R. § 111.95Under this subpart E, what records must you make and keep?