as of 2019 - 08 - 15
18 Inspections
18.A Principles
Summary
18.B Inspection procedures
Summary
18.B.1 System-based
18.B.2 Product-based
18.B.3 Procedure-based
18.B.4 Area-based
18.C Inspectors
Summary
18.C.1 Technical qualification requirements
18.C.2 Personal requirements
18.D Organization of inspections
Summary
18.D.1 Inspection planning
18.D.2 Inspection preparation
18.D.3 Carrying out the inspections
18.D.3.1 Opening discussion
18.D.3.2 Site inspection
18.D.3.3 Documentation check
18.D.3.4 Concluding discussion
18.D.4 Evaluation and documentation
18.E Self-inspection
Summary
18.E.1 Introduction
18.E.2 Objectives of self-inspections
18.E.3 Inspection areas
18.E.4 Frequency of self-inspections
18.E.5 Requirements for inspectors
18.E.6 Self-inspection process
18.E.6.1 Planning
18.E.6.2 Implementation
18.E.6.3 Wrap-up
18.E.6.4 Follow-up
18.E.7 Documentation
18.E.7.1 Sample report for self-inspections
18.E.8 Evaluation
18.E.8.1 Sample calculation for determining the GMP compliance of a quality management system
18.E.9 Periodic evaluation of the self-inspection system
18.F Inspection of contract manufacturers
Summary
18.F.1 Purpose of the inspection of contract manufacturer
18.F.2 Carrying out inspections of contract manufacturer
18.F.3 Handling of changes and deviations
18.G Inspection of suppliers
Summary
18.G.1 Purpose of the supplier inspection
18.G.2 Carrying out the supplier inspection
18.H Inspection of API manufacturers
Summary
18.H.1 Preparation of the inspection
18.H.2 Type of inspection
18.H.3 Inspection questionnaire
18.I Preparing for FDA GMP inspections
Summary
18.I.1 GMP inspections – both challenge and opportunity
18.I.2 Content preparation for the FDA inspection
18.I.2.1 The most common FDA objections
18.I.2.2 The FDA approach to the inspection of quality systems
18.I.2.3 The most important areas of inspection
18.I.2.4 You know your own shortcomings: How do you prepare for an emergency?
18.I.2.5 What will the inspector focus on?
18.I.3 Organisational preparation of FDA inspections
18.I.3.1 Project management is the basis for high efficiency
18.I.3.2 How is a perfect internal inspection team put together?
18.I.3.3 Organisation of the front and back office
18.I.3.4 Employees should prepare themselves to convince
18.I.3.5 How does one overcome the language barrier and fear of inspections?
18.I.3.6 How do you obtain information about the inspectors?
18.I.3.7 Scheduling GMP inspections
18.I.3.8 Other aspects of successful inspections
18.I.4 Behaviour during GMP inspections
18.I.4.1 How do you create awareness for GMP compliance in a company?
18.I.4.2 Successful strategies for demonstrating GMP-compliance
18.I.4.3 Meeting the expectations of the role
18.I.4.4 Role play when preparing for an inspection
18.I.5 The inspection procedure
18.I.6 Actions after the inspection
18.I.6.1 Inspection observations
18.I.6.2 Responding to FDA inspection observations
18.I.6.3 Establishment Inspection Report and other actions
18.I.7 Challenges of the future: Quality oversight, knowledge management and quality culture
18.I.7.1 Quality oversight
18.I.7.2 Knowledge management
18.I.7.3 Quality culture
18.J Questionnaire for preparing GMP-inspections
18.K References
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