Code of Federal Regulations · Subpart
Subpart E — Requirement To Establish A Production And Process Control System
21 C.F.R. pt. 111, subpt. E
- § 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?