Pharmaceutical GMP

21 CFR Parts 210/211 Drug GMPs with reference to Q7 

• 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

• 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 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 11 Basic Overview

• 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