sureassist introduction plan process equipment and utilities water treatment facility hvac system...
TRANSCRIPT
Project Management┃Qualification/ Validation┃Calibration┃Monitoring┃GMP Compliance
Qualification
& Validation
Project
Management
GMP Compliance
Calibration Monitoring
Conceptual Design
Basic Design
Technical Support For The Site
Project Management
Construction Supervision
Review Of Design Drawings
GMP Training For Construction Companies
Project Schedule Management
Guidance On Critical Surface Construction
Review Of Manufacturing Facilities And Equipment
Growth of
Production
Time & Cost
Saving Enhancement
of Company
Reliability
Effective
Quality
Control Compliance with
relevant
Regulations
Risk
Minimization
Cleanliness Facility Flow
Qualification plan
Process equipment and utilities
Water treatment facility
HVAC system
Computer and automation system
Building management system (BMS)
Risk assessment and URS
Qualification
Validation master plan (VMP)
Site Master File
Process validation
Cleaning validation
Validation lifecycle
management
Validation
Our service scope includes creation of CSV protocols, execution of tests in the site, and creation
of result reports. Performs CSV for WMS, LIMS, BMS, EMS, and MES.
Review of specifications
Calibration method
Calibration protocols
Guides and lifecycle review
SOP, calibration and reports
Conducted before installation
Conducted for maintenance after installation
HVAC, Compressed
Air
Temp. & Humidity of
Working Area and
Warehouse
HEPA Filter
Cleanroom, Pharmaceutica
l Water
Support for facility management program
Support for construction and engineering managements
Process engineering, process change and improvement
Process analysis
Layout review
Qualification report review
Validation document
review
Standards and SOP
review
GMP Compliance
SOP review and
establishment
Gap analysis
Risk analysis
Process analysis
Various documentation
system management
Documentation
GMP audit plan
Overall document
inspection
Site and facility inspection
Operator and manager
inspection
Showing a CAPA plan
Mock Inspection
Professionals with a lot of field experiences provide
practical and active training not only through lecture but
also through practice by selecting urgent technical themes
for engineers.
Provides a forum for the latest information sharing while
improving understanding of GMP of pharmaceutical
practitioners by performing demo workshop & mentoring
periodically.
No. Company Case Form Year
19
20
21
22
23
24
25
26
27
No. Company Case Form Year
28
29
30
31
32
33
34
35
36
37
No. Company Case Form Year
38
39
40
