Solution for

SPK Pharmaceuticals
Knowledge

SPK aims for CUSTOMER SATISFACTION.

Agenda

Company Information
Work Scope
Reference
Test Instruments
Promise
Thanks You
Structure

Equipment/Facilities
Computer System
1. VMP, IA, RA
1. VMP, IA, RA
2. Qualification(DQ, IQ, OQ, PQ)
2. Qualification (DQ, IQ, OQ)
3. Validation
3. Validation

1. On-Line, Off-Line Training

SPK 1. Process Risk Analysis
2. KGMP Compliance 2. Layout Development
3. Documents Development 3. Detail Design Review
4. Over Sea Consulting
History

2014
2012 QMS Implementation
Establishment of Research Checklist publication
Center

2010
[GMPSchool] Launching
2008
Transfer to Corporate,
2006, Foundation SPK
AGATHON & CEO, Commissioned GMP
SeerPharma Training Lecturer
authorized by KFDA

2006 2007 2008 2009 2011 2012 2015

2013
2011 [GMPSchool]
MOU Contraction with
CAI Supply to Hyang-nam
Pharmaceutical Complex

2007
CEO, Commissioned 2009
Validation Training [GMPSchool] Business
Lecturer authorized by Information Fair at Oct. 22
KPMA
Work Scope

Total Consulting Service System

SPK has a structure which provides all of services for pharmaceuticals including services from design of GMP factory to GMP compliance.
You can trust SPK’s companion.

Training Turn-Key Project

1. On-Line Training 1. Validation Master Plan

2. Off-Line Training 2. Impact Assessment
3. Project Master Plan
4. Validation Life-Cycle
FDA, EMEA Compliance

1. Foreigner Consulting
Qualification & Validation
2. FDA, EMEA Compliance
3. Pre Audit by FDA Expert 1. Validation Master Plan
2. Qualification Plan
AUDIT 3. Risk Analysis
4. DQ, IQ , OQ, PQ
1. GMP Implementation Evaluation
2. Mock-Inspection Conceptual Design
3. Pre Approval Inspection
1. Conceptual Design
2. Design Risk Analysis
3. Detail Design Review
Conceptual Design

3D Module Study Layout Development Detail Design RA

 Performing optimized  Continual revision of Layout  Layout optimization by
conceptual design requiring through workshops and semi- continual review of changes
the most effective based on meeting with customers usually occurred during
experiences at pharmaceutical detailed design development
 The provision of optimized
manufacturing field of GSK  Risk Analysis at the stage of
layout by provision of extensive
 Review of various location and selectable processes and detailed design progress, to be in
drawings through 3D Module manufacturing systems compliance with GMP
Study requirements
 Performs Layout development
 Minimization of try and errors until customer satisfies, for
for layout development by coincidence of conceptual
enough review of site plan before design and detailed design
the development starts
 Starting layout development, after
user’s approval

Page  6
Turn-Key Project
<Preparation & Establishement>
1. Standard Documentation
2. QMS Document
1. Process Risk Analysis 1. VMP & RA <Support Documentation>
2. Conceptual Design 2. FAT & SAT 1. Manufacturing Record
3. Detail Dsign Review 3. DQ, IQ, OQ, PQ 2. Quality Control Record
3. GMP Execution Evaluation Document
4. Product Registration / GMP Approval

Concept Design
Qualification Validation Compliance
Design Development

1. URS Development 1. Process Validation

2. F&DS Review 2. Cleaning Validation
3. DQ Report
4. RTM Documentation
Computer System Validation

Equipment , Utility IT System

 HVAC Management  Manufacturing Execution System (MES)
 Compressed Air System  Maintenance Management System (MMS)
 Water System  Calibration Management System (CMS)
 Manufacturing Equipment etc  Building Management System (BMS)
 Enterprise Resource Planning (ERP)
QC Analysis System  SCADA System etc



Stability System
Environmental Monitoring System (EMS)
Others
 Chromatography Data Acquisition System  Excel Spread Sheet Validation
 Laboratory Information System (LIMS)  Quality Management System

3. Design Review 5. SAT/FAT 7. Validation

& Development IQ, OQ Ending
2. Design 8. Validation
6. SOP
4. Development Operating SLA
Specification & PQ
& Testing
1. Validation
Strategy

Page  8
Turn-Key Project References

Daewha Pharm. Samjin Pharm. Binex Kukje Pharm.

 Conceptual Design and  Conceptual Design of New  Conceptual Design for  Conceptual Design of New
Equipment Qualification for Building for Aseptic Buildings for Building for Cephalosporin
New Building Construction  Qualification of Equipment Autocytotherapeutic Aseptic and Solid Dosage
 Qualification of 15 and Facilities for Sterile  Qualification of  Qualification of
Equipment for Solid Products Manufacturing Equipment Manufacturing Equipment
Dosage  Conceptual Design for and Facilities and Facilities
 Qualification of Equipment Existing Building  Conceptual Design of  Qualification of Equipment
for Remodeling  Qualification of Equipment Equipment for Remodeling for Solid Dosage in Existing
 Qualification of Equipment in Existing Building  Qualification of Equipment Building
for Solid Dosage  Qualification of Equipment
for Cataplasms
Remark  Qualification of Equipment for Aseptic
4 Projects during 6 years for Sterile Products
Remark
 Qualification of Equipment Remark
4 Projects during 5 years
for Instillations  4 Projects during 5 years

Remark
6 Projects during 7years

Page  9
Turn-Key Project References

Seoul Pharm. Dongkwang Pharm. Estech Pharma Kukjeon Pharm

 Conceptual Design for  Conceptual Design for New  Review of Detailed Design  Conceptual Design of New
Solid Dosage and Film Building for Cephalosporin and Design Risk Analysis of Building for API
Dosage Sterile Products New Building for API Manufacturing
 Qualification of  Conceptual Design for Manufacturing  Qualification of New
Manufacturing Equipment Remodeling of Existing  Qualification of Incoming Manufacturing
and Facilities Building Manufacturing Equipment Equipment and Facilities
 Process and Cleaning  Qualification of and Facilities and Risk
Validation Manufacturing Equipment Analysis in New Building  Process Validation and
 Qualification of Additional Cleaning Validation
and Facilities in
Manufacturing Equipment  Support of BGMP Gaining
Cephalosporin area
and Warehouse
 Qualification of
Manufacturing Equipment
and Facilities in Existing
Building

Remark
4 Projects during 5 years

Page  10
Turn-Key Project References

Ilshin Chemical KPX Medica Korea Dasan Medichem

 Conceptual Design of New  Conceptual Design of New  Conceptual Design of  Conceptual Design of
Building for API Building for API Remodeling for Existing Remodeling for Existing
Manufacturing Manufacturing Solid Dosage Solid Dosage
 Risk Analysis of New  Risk Analysis of New  Qualification of Existing  Conceptual Design of New
Equipment and Facilities Equipment and Facilities Equipment and Facilities Building for Solid Dosage
 Qualification of New  Qualification of New  Qualification of Equipment  Qualification of New
Equipment and Facilities Equipment and Facilities in Remodeled Area Equipment and Facilities
 Process and Cleaning  Qualification of Equipment
Validation and Facilities in Existing
 Computer System Buildings
Validation for HVAC and  Process and Cleaning
Water Generating System Validation

Page  11
Turn-Key Project References

Hanseo Pharm. Dream Pharma Comipharm Daehi Chemical

 Conceptual Design of New  Conceptual Design of  Conceptual Design of New  Conceptual Design of New
Building for API Remodeling for Existing Building for Solid Anti- Building for API
Manufacturing Solid Dosage Cancer Manufacturing Manufacturing
 Risk Analysis of New  Qualification of Existing  Qualification of Equipment  Qualification of New
Equipment and Facilities Equipment and Facilities in Existing Equipment and Facilities
 Qualification of New Buildings
Equipment and Facilities  Process Risk Analysis for
 Qualification of Equipment Anti-cancer manufacturing
and Facilities in Existing Building
Buildings
 Process and Cleaning
Validation

Page  12
Conceptual Design Project References

Kolmar Korea Korea United Pharm. Kuju Pharm. Unimed Pharm.

 Conceptual Design of  Conceptual Design of New  Conceptual Design of New  Conceptual Design of New
Remodeling for Building for Manufacturing Building for Manufacturing Building for Sterile
Manufacturing Facilities of Facilities of Anti-cancer Facilities of Sterile Products and Pastes
Semi-aseptic Product at Product Products and Solid
Existing Building Dosages
 Conceptual Design of  Qualification of
Remodeling for Manufacturing Facilities
Manufacturing Facilities of and Equipment of Sterile
Solid Product at Existing Products
Building
 Conceptual Design of New
Building for Manufacturing
Facilities of Sterile Product
at New Building
 Qualification of Facilities
and Equipment at Existing
Building

Page  13
Qualification Project References

Hanmi Pharm. Boryung Pharm Daewoong Pharm. Dong-A Pharm.

 Qualification of Equipment
for New GMP Building of
Cephalosporin
Manufacturing
 Qualification of Clean
Booth in New GMP Building
 Qualification of Equipment
at another site
 Qualification of
Manufacturing Equipment
at Paltan Factory
 Qualification of Remodeled
Area for Aseptics
 Qualification of Remodeled
Area for Solid Dosage (1st)
 Qualification of Remodeled
Area for Solid Dosage (2nd)
 Qualification of Remodeled
Area for Aseptics
 Qualification of Remodeled
Area for Packaging
Remark
4 Projects during 6 years
 Qualification of Remodeled
Area for Solid Dosage (1st)
 Qualification of Remodeled
Area for Solid Dosage (2nd)
Qualification of Remodeled
Area for Aseptics
 Qualification of Remodeled
Area for Solutions
 Qualification of Additional
Remodeling for Solid
Dosage
 Qualification of Equipment
dedicated to Ulsa
Manufacturing in Hyangnam
Site
Remark
8 Projects during 5 years
 Equipment Qualification for
Solutions at Cheon-an Site
 Qualification of Equipment
and Facilities at Dal-seong
Site
 Equipment Qualification at
Ban-Weol Site 1
 Equipment Qualification at
Ban-Weol Site 2
 Qualification of New
Warehouse Building
Remark
5 Projects during 7 years

Page  14
Qualification Project References

Hana Pharm. Huons SeongWoo Chemical Dae-woong Bio

 Equipment Qualification of  Equipment Qualification for  Qualification of 5  Qualification of 11
Existing Factory Solid Dosage and Aseptics Equipment for API Equipment for API
 Equipment Qualification of in New Building at Je- Manufacturing Manufacturing
Remodeled Area for Cheon Site  Qualification of  Qualification of 4
Instillations  Qualification of Changed Manufacturing Equipment Manufacturing Equipment
 Equipment Qualification of Manufacturing Equipment  Process and Cleaning
Remodeled Area for  Qualification of New Validation
Instillations Building for Botox
Manufacturing
Remark
3 Projects during 5 years Remark
4 Projects during 6 years

Page  15
Qualification Project References
Nexpharm Pharm.
 Equipment Qualification of
New Building for Solid
Dosage Manufacturing
Page  16
Seo-Heung Capsule
 Qualification of Equipment
in New Building at Osong
Site
 Qualification of Facilities
for Remodeling in New
Building at Osong Site
United Pharm. Kyung-Dong Pharm
 Facility Qualification of  Qualification of Facilities
New GMP Building for General Medicines
 Qualification of Equipment  Qualification of Warehouse
for Aseptic Manufacturing Area
 Conceptual Design of Anti-
Cancer Sterile Products
and Solid Dosage
Manufacturing Building
Remark
3 Projects during 3 years
CSV Reference

Shinpoong Phar=m Samil Pharm. Huons Daewoo Pharm

 CSV of 20 Equipment for  Design of ERP System to-  Design of ERP,LIMS, WMS,  Water System CSV
Solid Dosage be process RWS To-be Process  Pure Steam System CSV
Manufacturing  ERP System CSV  ERP System CSV  Ophthalmic Solutions Filling
 CSV of Aseptic  HVAC System CSV Line CSV
Manufacturing Equipment  PW System CSV
 CSV for 2D Bar Code  CA System CSV
System
Remark
Remark 5 Projects during 3 years
3 Projects during 3 years

Page  17
Computer System Validation References

Chong-geun Dang Dae-hwa Pharm. CJ Hwan-In Pharm.

 ERP System to-be process  Weighing Control System  ERP, EDMS, LIMS, To-be  ERP System to-be process
Design to-be process Design Process Design Design
 ERP System CSV  Weighing Control System  ERP System CSV  ERP System CSV
 POP System to-be process CSV  EDMS System CSV
Design  WMS System CSV  LIMS System CSV
 POP System CSV  Purified Water System CSV  LIMS System CSV

Otsuka Korea Pharm. Unimed Pharm. Hana Pharm. Dong-A Pharm.

 ERP System to-be process  RFID System to-be process  Vial Filling Line CSV  BMS System CSV
Design Design
 ERP System CSV  RFID System CSV
 CSV for 30 Manufacturing
Equipment

Page  18
Our Customers

SPK thinks customer is a friend, with perpetual relationship.

Page  19
Test Instruments

SPK contains its own testing instruments for qualification.

If you need any of them, please inform SPK.

Particle Counter PAO Generator Steam Quality Test Kit Dew Point Tester

Multi-Particle Counter Pressure Tester Flow Meter Temp. Humid. Sensors

Air Flow/Wind Speed Meter PAO Meter Digital Pressure Gauge Megger

Smoke Generator Temp./Pressure Meter Air Flow Meter Storage Room

Page  20
Our Strengths

Strengths of Conceptual Design Team of SPK

 SPK performs conceptual design based on experiences at

various pharmaceutical field for over 10 years. It is the most
important evaluation elements.

 If conceptual design is performed without production experiences,

the product is prepared only for fulfillment for the guideline,
without deep considering field situation. SPK suggests optimized
layout, for reducing increment of construction cost due to over-
design.

 SPK has the remarkable competences for developing Layout for

conceptual design. SPK contains the optimized formats for
various dosage forms and specifications, based on experiences
for forty pharmaceuticals.

 SPK supports various change control completely to be performed

by customer working staffs after the completion of conceptual
design process. SPK aims at fully support to minimize trials and
errors occurred practically at detailed design and construction.
Our Promises

SPK aims for customer satisfaction. For this, we promise followings.

1. SPK does not seek our profit through consulting.

2. SPK seeks your satisfaction by supporting through consulting.
3. SPK supports your upgrade for GMP management through consulting
by various tools.

We are only satisfied

when we have
exceeded your
expectations.
Thank You.