GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs

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US FDA Title 21 CFR PARTS 11, 210/211 and 820 Pocket Guide

3 popular regulations in an easy to carry pocket handbook.

  • US FDA Title 21 CFR Part 11
  • Part 11 Electronic Records; Electronic Signatures
  • Scope and Application - August 2003

This regulation pertains to electronic records, electronic signatures and handwritten signatures executed to electronic records. This part also applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted, under any records requirements set forth in agency regulations.

Also includes Scope and Application 2003 - FDA Interpretation of Part 11 Requirements.

US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices

  • The regulations set forth in parts 210/211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.
  • US FDA Title 21 CFR Part 820 Quality Systems Regulation The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

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Day 1 Topics Day 2 Topics

Part 11 and Systems Validation:

  • 21 CFR Part 11 Definitions, System Types and Classifications
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • Part 11.10 Sections a) - k)
    • (a) Validation
    • (b) Copies of records
    • (c) Protection of records
    • (d) Limiting system access
    • (e) Audit trails
    • (f) Operational system checks
    • (g) Authority checks (h) Device checks
    • (i) Education, Training, Experience
    • (j) Policies and Procedures
    • (k) Systems documentation
  • Risk Analysis - Determine Which Systems Need to be Validated
  • Steering Committee and Charter

21 CFR Parts 210/211 Drug GMPs

  • GMPs - The Basics
  • The Predicate Rules - Basics
  • Attitudes and Behavior Patterns
  • Organizational & Management Responsibilities
  • Document Control Program
  • Employee Orientation, Quality Awareness, and Job Training
  • Plant Safety and Security
  • Internal Quality/GMP Training Session Program
  • Quality Cost Program
  • Design Control
  • Facility Design and Layout
  • Environmental Control Program
  • Facility Maintenance and Good
  • Housekeeping Program
  • Outside Contractor Control Program
  • Equipment Design and Placement
  • Equipment Identification
  • Equipment Maintenance & Cleaning
  • Measurement Equipment Calibration Program
  • Equipment Qualification Program
  • Material/Component Specification and Purchasing Control
  • Material/Component Receipt, Inspection, Sampling, and Laboratory Testing
  • Material Component Storage and Handling
  • Inventory Control Program

21 CFR Parts 210/211 Drug GMPs (Cont)

  • Vendor (Supplier) Control Program
  • Material/Component/Label Verification, Storage, and Handling
  • Equipment/Line/Area Cleaning, Preparation, and Clearance
  • Operational Process Validation and Production Change Order Control
  • In-Process Inspection, Sampling, and Laboratory Control
  • Reprocessing/Disposition of Materials
  • Finished Product Verification, Storage, and Handling
  • Finished Product Inspection, Sampling, Testing, and Release for Distribution
  • Distribution Controls
  • Marketing Controls
  • Complaint Handling and Customer Satisfaction Program

21 CFR Part 820 Predicate Status Rules

ICH Q7 - GMPs for Active Pharmaceutical Ingredients:

  • Introduction
  • Quality Management
  • Personnel
  • Buildings and Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and In-Process Controls
  • Packaging and Identification
  • Labeling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Validation
  • Change Control
  • Rejection and Re-Use of Materials
  • Complaints and Recalls
  • Contract Manufacturers (Including Laboratories)

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