dpl compliance road map
TRANSCRIPT
Critical Parameter
Trending
Issue
Purchase Orders
The Road Map to
GMP Compliance
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Dawat Pharma Ltd 83 Bescot Street, Walsall WS1 4HY
United Kingdom Contact Dr Tanveer Ahmed Tel: +44 (0)7917 664718 Email: [email protected]
Develop URSs Develop Basic
Design
Develop Process Rationale Project Brief
Define Systems
Develop
Production SOPs
Drawing
Control
System
Supplier
Audits
Approve URSs
Approve Basic
Design
Perform GMP Design
Review
Generate
Procurement Packages
Develop Detailed
Design
Detailed list of applicable
requirements including: • Corporate & Site Standards
• Applicable CGMPs
• Regulatory Submission
• Health & Safety
• Good Engineering Practice
• Environmental
• User Requirements
Perform HAZOP
Review for
HAZOPS, etc.
Generate and Approve
Project VMP
Develop
Batch Record
Sheets
Release
Analytical
Methods
Compliance
Audits
Cleaning
Validation
Annual Product
Review
Validate
Analytical
Methods
Establish
Engineering
Systems
Facility Layout Drawings
Equipment List
Critical Instrument List
P&IDs
Current Calibration Certificates
Certification for Contact Materials
Certification for Contact Substances
Spare Parts Lists
Cleaning Procedures
Maintenance Procedures
Maintenance Schedules
Cleaning Schedules
Calibration Schedules
System Categorisation
Risk Assessments
FAT
SAT
Software Testing
Hardware Testing
Generate & Approve
QC VMP Generate & Approve
PCS VMP
Generate & Approve
Facility VMP Generate & Approve
Cleaning VMP Generate & Approve
C&Q Plan
Process
Optimisation
Operation
Qualification
Installation
Qualification
Performance
Qualification
Process
Validation
Routine
Production
GAMP
URS
Supplier Assessment
Traceability Matrix
Functional Specification
Design Specifications
Test Specifications
Quality Plans
SAT
Commissioning
FAT
Revalidation
Calibration
Planned
Preventative
Maintenance