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Honeyman PCS |
GMP Regulatory Compliance Life Cycle
The pages in this
section illustrate the processes of the GMP Life Cycle and demonstrate the
integration of the expertise and skill sets of Honeyman Group and PCS (The
Netherlands).
Beneath each broad category is an
indicative summary of the core deliverables - click each heading for more
information.
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FACILITIES
Process Mapping
Process Design
Architectural Services
Civil Works and Build
Utilities
Project Management |
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EQUIPMENT
User Requirement
Specification
Vendor Appraisal
Procurement
Validation DQ to PQ
FAT’s/SAT’s
Installation & Commissioning
Software and Validation |
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TRAINING
Training Requirement
Matrix
Competency Assessed
Development and Delivery |
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DRUG DEVELOPMENT
Clinical Trail Manufacture
Scale Up
CT Licensing
Product Transfer
Due Diligence Audits |
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QUALITY SYSTEM
Design
Implement
Monitor
Optimisation
Quality Manual
SOP’s
Self Inspection |
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REGULATORY AFFAIRS
Drug Master File
MAA/NDA
Certificate of Suitability
License Applications
Expert Reports
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PROCESS VALIDATION
Risk Analysis
VMP
Protocol and Reports
Execution
Analytical Support
Project Management |
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ONGOING SUPPORT
Troubleshooting and
Process Optimisation
Change Control and Continuous Compliance
Requalification
Audit and Inspection (API & Secondary Manufacture)
Interim Management |
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