GCI0056 Imexpharm C2 Rev 04 17012013

Global Compliance
(International) Ltd
PIC/s Good Manufacturing Non Compliance

Remediation Services
For
Imexpharm Pharmaceutical JSC, Cephalosporin
Solid Dosage and Injectable Plants, Bin Duong
Province, Vietnam
GCI Proposal ref 0056 C2: Revision 04
By
Private and Confidential Page 1 of 12 Revision 04 17th January 2013

Copyright Global Compliance Management Trust
GCI0056 C2 Confidential Ltd, Vietnam
PICs GMP NON COMPLIANCE REMEDIATION SERVICES - IMEXPHARM PHARMACEUTICAL
JSC, CEPHALOSPORIN SOLID DOSAGE AND INJECTABLE PLANT, BIN DUONG PROVINCE,
VIETNAM
Contents
1. INTRODUCTION AND EXECUTIVE SUMMARY ......................................................................... 3
2. PROGRAME OF WORKS ............................................................................................................... 4
3. POTENTIAL GCI PROJECT TEAM MEMBERS ........................................................................... 8
4. COMMERCIAL PROPOSAL .......................................................................................................... 9
4.1 FEE ............................................................................................................................................ 9
5. COMMERCIAL TERMS AND CONDITIONS .............................................................................. 10
6. PROPOSAL ACCEPTANCE ......................................................................................................... 11
Appendix 1
GCI0056 C2 Rev 04 Contract Agreement for PICs GMP Non Compliances Remediation Services

VIETNAM
1. INTRODUCTION AND EXECUTIVE SUMMARY
Global Compliance (International), a trade name of Global Compliance Management Trust
(here after named GCI) has previously provided PICs Good Manufacturing Practice GAP
Analysis Consultancy to Imexpharm Pharmaceutical JSC (here after Imexpharm).
Following email conference between Ashley Hankinson, Managing Director, GCI and
detailed discussions with Imexpharm Pharmaceutical JSC (here after named Imexpharm) GCI
has been asked to develop this proposal, for Support in the Remediation of PICs GMP Non
Compliances at Imexpharm's Solid Dosage and Injectables Plant at Bin Duong Province,
Vietnam.
At this Time, Such Consultancy Areas Covered Within the Scope of this Proposal Will
Include:
- Process Mapping, Comprehensive Systems Review & Evaluation. Systems Undergoing

Mapping, Review and Evaluation Will Include Quality, Manufacturing, Packaging,
Laboratory, Materials, Equipment and Facilities
- Document Review and Development of Corrective Actions
- Training and On Site Consultancy
- Validation and Qualification On Site and Off Site Support
This New Proposal has Been Developed by GCI as Part of Its Continued Commitment to
Supporting Imexpharm and Willingness to Work With Imexpharm.
GCI would be Willing to Meet Face to Face With Imexpharm in Order to Revise this
Proposal Further if Required in Order to Activate this Project by GCI to Support
Imexpharm.
Fees Associated With the TGA and Australian Registration Project Have Been Supplied
Within GCI Proposal GCI0054 Rev 05,17th January 2013.

VIETNAM
2. PROGRAME OF WORKS
GCI Will Provide the Required Services and Consultancy as Requested by Imexpharm,
Specifically to the Following Areas, Note This Scope Can Be Revised by Imexpharm in Line
with Budget and Business Requirments:
Activity Group 1
- Process Mapping, Comprehensive Systems Review & Evaluation. Systems Undergoing

Mapping, Review and Evaluation Will Include Quality, Manufacturing, Packaging,
Laboratory, Materials, Equipment and Facilities It is Anticipated that Each System
Undergoing Mapping, Comprehensive Review and Evaluation will take Approximately 1
week (7 Days) to Complete Including Reporting. The Purpose of the Mapping, Systems
Review and Evaluation will Be to:
 Identify Progress on the Resolution of Issues/Non Compliances Already Identified by
GCI During the GAP Analysis Phase
 Identify Additional Non Compliances and Propose Remedial Solutions
 Provide Advice and Consultancy on System Improvements
It is anticipated Each Month, GCI Will Complete 1 System Per Month, In Parallel with On
Going Documentation Review and On Site Consultancy & Training
Activity Group 2
- Document Review and Development of Corrective Actions. GCI Will Complete an Off Site
Review and Critique of the Following Documents. Post Review GCI Will Email Comments
and Any Proposed Corrective and Remedial Actions to Imexpharm. It is Expected that Prior
to Review by GCI, that Imexpharm Translate the Documents and Provide Between 3-5 of the
Documents by Email to the GCI Project Manager for Distribution and Review at GCI Offices.
Note, As the project progresses, the document selected for translation and review may be
changed, so long as the number of documents remains the same.
Proposed Documents for Translation and Review:
 Site Master File

 Quality Manual
 Business Continuity Plan
 Quality Risk Management Procedure
 Roles and Responsibilities of the Quality Unit & Production
 Training Including Production, QC and QA Personnel Working on Product Manufacture,
Warehousing, Testing and Release
 Self-Inspection Procedure and Programme
 Corrective and Preventative Action (CAPA) Procedures
 Handling of Complaints
 Vendor/Supplier Approval and External Audit Programmes
 Internal Audit Programme
VIETNAM
 Procedures for ensuring that TSE-Risk Materials are not Handled on Site
 Cephalosporin Monitoring Program
 Procedures for Generating/Approving GMP Documents
 Management of printouts
 Management of equipment logbooks
 Document Issue and Control Procedures
 Change Control
 Deviation Reporting and Investigation procedure
 Handling of Environmental monitoring and utility excursions
 Procedure for Batch Documentation review
 Product Quality Review
 Calculation Checks
 Health Monitoring
 Entry Control Procedures
 Specification for Clean Utilities
 Specifications for Primary Packaging
 Specifications for Printed Packaging
 Master Batch and Packaging Record
 Starting Materials Retest Period and Expiration management
 Recall Procedure
 Managing Regulatory and Customer Audits
 Control of Analytical samples
 Storage and Preparation of Microbiological Reference and Working standards
 Storage & Control of Reference Standards and Retained Samples
 Column receipt and management
 Method Validation for TGA Selected Products
 Issue & Control of Specifications and Methods
 Starting Materials Sampling Procedures
 Analytical Reference Material Management Procedures
 Quality Control Unit Release Procedure
 Out Of Specification Management
 Certificate of Analysis Management
 Stability Testing
 Microbiological Monitoring of Personnel
 Management of Microbiological Media
 Bioburden and Endotoxin testing
 Identification of microbial isolates
 Sterility Testing Procedure
 Environmental Monitoring of Cleanrooms
 Monitoring and Trending procedure for Clean Utilities
 Routine Sampling of Water and Steam systems
 Routine Sampling of Product Contact gases
 General Laboratory Glassware cleaning
 Laboratory Glassware cleaning with low TOC requirement
 Disposal of Hazardous laboratory waste
 Disinfectant effectiveness testing

VIETNAM
 Site Validation Master Plan

 Cleaning Validation for Site
 Requirements Tracability Matrix procedure
 System Boundary and Impact Assessment procedure
 Component Criticality Assessment procedure
 Procedure for Qualification and Re-Qualification of Classified facilities
 Procedure for Validation of Sterilization using Saturated Steam
 Procedure for Validation of Sterilization using Dry Heat Tunnel
 Procedure for Validation of Storage and hold times
 Qualification of Climate controlled systems
 Procedure for Media Fill
 Disaster Recovery Procedure
 Computerised systems back up procedures
 Emergency power procedures and testing
 Personnel and material flow diagrams
 Pressure differential and Classification layouts
 Control and monitoring of temperature and relative humidity
 Pest control
 Monitoring alarms
 Preventive and Unplanned Maintenance
 Calibration principles
 Calibration of Weighing Devices
 Calibration of Temperature measuring devices
 Calibration of Pressure monitoring devices
 Sanitzation of WFI and PW
 Integrity testing of Sterile filters
 HVAC, use cleaning and routine maintenance
 Compressed air operation and preventive maintenance
 Water and Steam systems operation and preventive maintenance
 Service Agreements procedure
 List of all Computer systems
 System Descriptions and Architecture for Major Systems
 Printed Packaging Component Management
 Status Labelling and material segregation
 Incoming Goods Check
 Warehouse stock management
 Issue of material to production
 Rejected material and product handling
 Personnel gowning procedures
 Laundering and sterilisation of clean room clothing
 Behaviour and Practice for working in Aseptic processing areas
 Cleaning and Sanitisation of Cleanrooms
 Material Reconciliation
 Line Clearance
 Intermediate storage organisation
 Dispensing operations

VIETNAM
 Routine testing of integrity of vial closure

 Routine testing of integrity of Blisters
 Dismantling and transfer of Machine components and tools for washing
 Washing and drying of Machine components and tools
 Chemical Sanitization of components and tools
 Material transfer into the Aseptic area
 Preparation, loading and autoclaving of Machine components and tools
 Preparation loading and operation of Vial Washer
 Preparation and operation of Sterilising tunnel
 Preparation and operation of Filling Line
 Preparation and operation of Capping Line
 Storage of Sterilised stoppers
 Storage of Sterilised tools and machine parts
 Transfer of API into Filling Hopper
 Transfer of Stoppers into Stopper Hopper
 Coating machine operation, cleaning and routine maintenance
 Capsule filling machine machine operation, cleaning and routine maintenance
 Metal detectors operation, cleaning and routine maintenance
 Blister packing machine operation, cleaning and routine maintenance
 Tabletting machine and deduster operation, cleaning and routine maintenance
 Blender operation, cleaning and routine maintenance
Activity Group 3
Training and On Site Consultancy. GCI Will Attend Site 5 Days per Month for 12 months to
Provide up to 2 days Formal Training on Aspects PIC/s GMP (topics to be agreed) and to
Review Overall Project Progress and Provide Advice and Consultancy. It is Proposed that
the Specific Training Courses Be Mutually Agreed Between Imexpharm and GCI on
Acceptance to this Proposal.
Activity Group 4
Validation and Qualification On Site and Off Site Support. It is Proposed that GCI Provide
Examples of Compliant Validation and Qualification SOPs, Plan and Protocols Developed
Specific to Items of Equipment/Systems at Imexpharm
GCI will provide a validation expert to write validation documents for the Following Items of
Equipment/Systems
- Filling Line IQ, OQ PQ

- Autoclave IQ, OQ, PQ
- High Performance Liquid Chromatography System IQ, OQ, PQ
- Chromatographic Data Aquistion Software ,IQ and OQ,
- Dissolution Bath and UV Spectrophotometer IQ, OQ PQ
VIETNAM
- Annex 11 Compliance SOP (Electronic Records and Signatures)
- Computer Validation and Annex 11 Compliance Plan for the Site
Imexpharm can Use These Documents as the Basis for the Remaining Protocols that they
Need to Write.
Note, GCI Has Not Included Any Other Protocol/SOP for Writing, Review or Any Execution
Activity in Our Scope of Works at this Time.
We anticipate that it will take about 12 months in total to make the required changes so that
Imexpharm will be confident of passing a PIC/s GMP inspection. This excludes any lead-time
for purchases if new equipment is required
3. POTENTIAL GCI PROJECT TEAM MEMBERS
- Ashley Hankinson
- Tony Hughes
- Barrie Puttock
- Donna Brittain
- Steve Slater
- Phil Smith
- Philip Buen
- Nino Uy
Additional Resource and Skill Set as Needed by the Project.

VIETNAM
4. COMMERCIAL PROPOSAL
4.1 Fee
GCI, Party A will provide the consultancy services to Party B Detailed for the Reimbursable
fees detailed below, Exclusive of Expenses (Note, These Will be Invoiced Throughout the
Project and are In Addition to the Reimbursable Fees Detailed in this Agreement).
Consultant US$150 per Hour (Significant Reduction in Man Day Rate)
Estimated Expenses:
- Return Trips from GCI Offices to Imexpharm
- Return Trips from GCI Offices to 3rd Party Offices
- Local Hotel Accommodation When Away from GCI Offices
- Transfer to and from GCI Offices to Airport
- Transfer to and from Local Airport to Meeting Sites and Hotel
- Subsistence
- Communication e.g. Phone and Internet.
This proposal is Subject to the Terms and Conditions Detailed in Section 5.0.
In order to maintain budget control by Imexpharm, it is proposed that GCI provide monthly
man day estimates for the completion of the project until the successful PICs certification to
Imexpharm.

VIETNAM
5. COMMERCIAL TERMS AND CONDITIONS
1. This Proposal is valid for 21 days from the date indicated therein.
2. The works described shall only be undertaken on receipt of a purchase order accepting
full terms of conditions detailed in this document.
3. 150 Man Days of Fees would be invoiced and payment due on acceptance of this proposal
and prior to commencement of the project. Remaining fees and expenses would be invoiced
proportionally and monthly throughout the project.
4. As GCI provides advice and counsel TGA, European Union, U.S. Food and Drug
Administration (hereby noted as “FDA”), Japanese, Vietnam , PIC, WHO and or any other
regulated industries, it is important for the Client to agree and acknowledge, upon acceptance
of this proposal and agreement, that GCI , and its employees and agents will
exercise utmost diligence and effort to provide their best, most accurate, and sound
judgments in regards to advice, counsel, services, and decisions provided under this
Agreement to the Company in regards to regulations and laws enforced by any and all
regulatory authorities. The company agrees and understands that GCI makes no
claims to represent the past, present, or future opinion of the said authority regarding its
advice and makes no guarantees that the advice and counsel will guarantee favourable
regulatory decisions or protect the Company from unfavourable regulatory actions (e.g.,
sanctions, Warning Letters, non-approval of applications, etc.) by the relevant authority.
5. GCI would have budget, selection and oversight control for the use of additional
third parties for compliance related activities for the duration of the project.
6. The offer is exclusive of all local taxes, and is priced in United States Dollars.
7. The terms and conditions set out in this proposal shall be construed and interpreted in
accordance with the laws of New Zealand.
8. GCI reserve the right to charge additionally for works and materials not described in the
enclosed Proposal as discussed and approved by the Respective Clients through out the scope
of the project.
9. This proposal has been based upon there being full continuity of work or the work being
carried out in accordance with an agreed programme, unless otherwise mutually and formally
agreed.

VIETNAM
6. PROPOSAL ACCEPTANCE
Signed for Acceptance on Behalf of Imexpharm
Name:
Title:
Authorised Signature:
Date:
Respective Client Company Stamp
Signed for Acceptance on Behalf of Global Compliance Management Trust
Name: Edward Ashley Hankinson
Title: Managing Director
Authorised Signature:
Date:

VIETNAM
APPENDIX 1
GCI0056 C2 REVISION 04
Contract Agreement


GCI0056 Imexpharm C2 Rev 04 17012013

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

GCI0056 Imexpharm C2 Rev 04 17012013

Uploaded by

Copyright:

Available Formats

Global Compliance

PIC/s Good Manufacturing Non Compliance

GCI Proposal ref 0056 C2: Revision 04

Private and Confidential Page 1 of 12 Revision 04 17th January 2013

2. PROGRAME OF WORKS ............................................................................................................... 4

3. POTENTIAL GCI PROJECT TEAM MEMBERS ........................................................................... 8

4. COMMERCIAL PROPOSAL .......................................................................................................... 9

4.1 FEE ............................................................................................................................................ 9

5. COMMERCIAL TERMS AND CONDITIONS .............................................................................. 10

6. PROPOSAL ACCEPTANCE ......................................................................................................... 11

Private and Confidential Page 2 of 12 Revision 04 17th January 2013

- Process Mapping, Comprehensive Systems Review & Evaluation. Systems Undergoing

- Document Review and Development of Corrective Actions

- Training and On Site Consultancy

- Validation and Qualification On Site and Off Site Support

Private and Confidential Page 3 of 12 Revision 04 17th January 2013

- Process Mapping, Comprehensive Systems Review & Evaluation. Systems Undergoing

Proposed Documents for Translation and Review:

 Site Master File

Private and Confidential Page 5 of 12 Revision 04 17th January 2013

 Site Validation Master Plan

Private and Confidential Page 6 of 12 Revision 04 17th January 2013

 Routine testing of integrity of vial closure

- Filling Line IQ, OQ PQ

3. POTENTIAL GCI PROJECT TEAM MEMBERS

Additional Resource and Skill Set as Needed by the Project.

Private and Confidential Page 8 of 12 Revision 04 17th January 2013

Consultant US$150 per Hour (Significant Reduction in Man Day Rate)

Private and Confidential Page 9 of 12 Revision 04 17th January 2013

Private and Confidential Page 10 of 12 Revision 04 17th January 2013

Signed for Acceptance on Behalf of Imexpharm

Respective Client Company Stamp

Signed for Acceptance on Behalf of Global Compliance Management Trust

Name: Edward Ashley Hankinson

Title: Managing Director

Private and Confidential Page 11 of 12 Revision 04 17th January 2013

Private and Confidential Page 12 of 12 Revision 04 17th January 2013

You might also like