Framework For Integrating Standards and Regulations
The GMP Institute's Framework for Integrating Regulations and Standards is
detailed below. It provides a list of controls broken down into seven areas, which
should be evaluated in order to assure that you are operating in a state of control.
Use this framework as to help as you continuously improve your systems, enhancing your levels of compliance and performance.
The subsections below are linked to pertinent questions and answers
extracted from FDA's publication entitled Human
Drug GMP Notes.
1.1 Organizational and Management Responsibilities
1.2 Document Control System
1.3 Employee Orientation, Quality Awareness, and Job Training Program
1.4 Plant Safety and Security Program
1.5 Internal Quality/GMP Audit Program
1.6 Quality Cost Program
2.1 Product Design and Specification Control
2.2 Product Process Design Control
2.3 Quality Assurance Design and Specification
Control
2.4 Design Validation Control
2.5 Design Change Control
3.1 Facility Design and Layout
3.2 Environmental Control
Program
3.3 Facility Maintenance and
Good Housekeeping Program
3.4 Outside Contractor Control Program
4.1 Equipment Design and Placement
4.2 Equipment Identification and Log Books
4.3 Equipment Maintenance Program
4.4 Measurement Equipment Calibration Program
4.5 Equipment Qualification Program
5.1 Material/Component Specification and Purchasing Control
5.2 Material/Component Receipt, Inspection, Sampling and Laboratory
Testing
5.3 Material/Component Storage and Handling
5.4 Inventory Control Program
5.5 Vendor Control Program
6.1 Material/Component /Label Verification,
Storage, and Handling
6.2 Equipment/Line/Area Cleaning, Preparation, and
Clearance
6.3 Operational Process Validation and Production
Change Order Control
6.4 In-Process Inspection,
Sampling, and Laboratory Control
6.5 Reprocessing/Distribution
of Material
7.1 Finished Product Verification, Storage, and Handling
7.2 Finished Product Inspection, Sampling, Testing, and
Release for Distribution
7.3 Distribution Controls
7.4 Marketing Controls
7.5 Complaint Handling and Customer Satisfaction Program
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