Pharmaceutical GMP
1-Day Curriculum
Drugs, Dietary Supplements, 503B, or Biologics
21 CFR Parts 210/211 Drug GMPs with reference to Q7
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The 11 General Orders of GMP
- Writing Procedures
- Following Procedures
- Good Documentation Practice
- Validation
- Design/Build Facilities
- Maintain Facilities
- Training, Education and Experiance
- Sanitation and Housekeeping
- Control for Quality
- Audit for Compliance
- Prepare for Battle - Recall/Traceability -
The Predicate Rules - Basics
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Attitudes and Behavior Patterns
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Organizational & Management Responsibilities
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Document Control Program
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Employee Orientation, Quality Awareness, and Job Training
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Plant Safety and Security
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Internal Quality/GMP Training Session Program
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Quality Cost Program
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Design Control
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Facility Design and Layout
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Environmental Control Program
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Facility Maintenance and Good
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Housekeeping Program
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Outside Contractor Control Program
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Equipment Design and Placement
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Equipment Identification
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Equipment Maintenance & Cleaning
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Measurement Equipment Calibration Program
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Equipment Qualification Program
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Material/Component Specification and Purchasing Control
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Material/Component Receipt, Inspection, Sampling, and Laboratory Testing
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Material Component Storage and Handling
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Inventory Control Program Vendor (Supplier) Control Program
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Material/Component/Label Verification, Storage, and Handling
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Equipment/Line/Area Cleaning, Preparation, and Clearance
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Operational Process Validation and Production Change Order Control
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In-Process Inspection, Sampling, and Laboratory Control
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Reprocessing/Disposition of Materials
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Finished Product Verification, Storage, and Handling
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Finished Product Inspection, Sampling, Testing, and Release for Distribution
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Distribution Controls
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Marketing Controls
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Complaint Handling and Customer Satisfaction Program
21 CFR Part 11 Basic Overview
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Part 11.10 Sections a) - k) (a) Validation
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(b) Copies of records
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(c) Protection of records
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(d) Limiting system access
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(e) Audit trails
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(f) Operational system checks
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(g) Authority checks (h) Device checks
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(i) Education, Training, Experience
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(j) Policies and Procedures
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(k) Systems documentation
Training includes:
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Handbooks for specific industry
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Workbook Binders
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Certificate of Attendance
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Q&A Sessions
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Access to GMP Helpdesk