GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 210/211 - Drug GMPs

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The GMP 210/211 regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

U.S. Food and Drug Administration Code of Federal Regulations Mini Handbooks Available in Spiral or Perfect Binding

GMP Publications Quality Compliance Publications Helping Companies Meet and Exceed FDA and Total Quality Management Standards.

This is a great training and information tool to provide all employees with the CFR requirements for the Food, Drug, Medical Device, Cosmetic, Healthcare, Electronic Records and Good Laboratory Practice.

They fit neatly into your pocket. (size 3.75" x 6.25")

For persons who purchased this item, you may also be interested in: GMP Auditorís Basic Handbook










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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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GMP International Master Reference Guide

Over 900 pages of GMP guidances and regulations to ensure your compliance is up to date! Includes US, EU, ICH, Canadian and Japanese!

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