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Technology Transfer of Contract
Manufactured Products
May 2012
ESKİŞEHİR
Transfer Process
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Transfer processes taken place in PharmaVision are led by Transfer Operations Department
Responsibilities are;
 Ensuring the information and documentation flow
 Coordination of related departments during the transfer process and its follow-up
 Preparation of new product notification
 Performing all process validation batches
 Ensuring cleaning validation
 Ensuring equipment qualifications of any equipment procured for related transfer
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R&D – Product Transfer
Management
Dr.Ecz.Yıldız Özalp
R&D
Product Transfer
Manager
Product Transfer
and
Process Validation
5 staff
Method
Development
and Transfer
2 teams of 3
6 staff in total
Formulation
Development
3 staff
Product Transfer Team
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Project Leader from Product Transfer Group
Multi-disciplinary project team involving
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Business Development
Analytical Method Transfer Team
Process Validation Supervisor
Production Manager
Packaging Control Lab.
Quality Control Lab.
Quality Assurance
Engineering
Supply Chain (if materials are supplied by PhV)
Project Management
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PROJECT INITIATION
STAGE 1
Feasibility
STAGE 2
Conceptual
Development
PLANNING
STAGE 3
Project Delivery
Planning
PROJECT DELIVERY
STAGE 4
Design
STAGE 5
Implementation
STAGE 6
Close-out
Initiation Stage
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STAGE 1
Feasibility
STAGE 2
Conceptual
Development
CDA
Procurement of Technical Documents
Feasibility and Pricing Studies
Quotation
Price Approval
Quality Agreement
Contract Manufacturing Agreeement
Review of Detailed Technical Documents
Request of Additional Docs if needed
Filling Product Transfer Info Sheet
Assesment of Analytical Needs
Assesment of Tooling / Equipment Needs
Prep. & Approval of Drawings for Punches & Formats
Preparation of BOM for Production
Preparation of BOM for Packaging
Prep. & Approval of Artworks for Packaging Mat.
PROJECT INITIATION
Planning Stage
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STAGE 3
Project Delivery
Planning
Prep. & Approval of New Product Notification
Purchase Order of Analytical Needs
Purchase Order of Starting Materials
Purchase Order of Packaging Materials
Purchase Order of Punches & Formats
Prep. & Approval of Analytical Method Transfer / Validation / Verification protocol
Prep. & Approval of Master Batch Production Records
Prep. & Approval of Master Batch Packaging Records
PLANNING
Delivery Stage
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STAGE 5
Implementation
STAGE 4
Design
Production of Validation Batches
Analyses of Validation Batches
Packaging of Validation Batches
Sampling for Stability Studies
Procurement of Analytical Needs
Procurement and Release of Starting Materials
Procurement of Punches & Formats
Analytical Method Tr. / Val. / Ver.
Prep. & Approval of Method Tr. / Val. / Ver. Report
Method Transfer to QC
Prep.& Approval of Test Methods for
Raw Materials, Finished Product , IPC, Microbiology, Pack. Mat.
Prep. & Approval of Process & Pack. Validation Protocols
Prep. & Approval of Stability Protocol
Completion and Approval of Product Transfer Action Plan
STAGE 6
Close-out
Prep. & Approval of Process Validation Report
Prep. & Approval of Packaging Validation Report
Prep. of Required Documentation for Authorities
Stability Tests and Reports in Due Time
Project Handover for Routine Manufacturing
Continous Improvement Projects
PROJECT DELIVERY
Transfer Process
Stages 1-2-3
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STAGE 3
Project Delivery
Planning
STAGE 2
Conceptual
Development
STAGE 1
Feasibility
Confidentiality
Agreement
Procurement of
Technical Docs
Feasibility
& Pricing
Studies
Quotation and
Price Approval
Quality &
Contract Manuf.
Agreement
Filling
Product
Transfer
Info Sheet
Assesment of
Analytical
Needs
Assesment of
Tooling
Needs
Prep. of
BOM for
Production
& Packaging
Preparation &
Approval of
Artworks
Prep. & Approval
of
New Product
Notification
Purchase Order
of
Analytical Needs
Purchase Order
of
Punches & Formats
Purchase Order
of
Starting Materials
Purchase Order
of
Pack. Materials
Transfer Process
Stage 4
STAGE 3
Project Delivery
Planning
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Prep. & Approval
Of New Product
Profile
Issuance of
Change Control
Document
Prep. & Approval of
Method Tr./Val./Ver.
Protocol
Prep. & Approval of
Master Batch
Production & Packaging Records (SAP)
STAGE 4
Design
Method Tr. / Val. / Ver.
Prep. & Approval of
Process & Pack.
Validation Protocols
Prep. & Approval
of Method Tr. / Val. / Ver. Report
Method Transfer to QC
Prep. & Approval of Test Methods
Prep. & Approval of Stability Protocol
Procurement
of Analytical
Needs
Procurement & Release
of all
Starting Materials
Procurement of
Punches & Formats
Completion and Approval of Product Transfer Action Plan
Transfer Process
Stages 5-6
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STAGE 6
Close-out
STAGE 5
Implementation
Completion and Approval of Product Transfer Action Plan
Production* and Analyses
of
Validation Batches
Packaging of
Validation Batches
Sampling for
Stability Studies
Prep. & Approval of
Process Validation Reports
Prep. & Approval of
Pack. Validation Reports
Stability Test and Reports
in Due Time
* Participation of MAH (Marketing Authorization Holder) for the 1st production
Preparation of Required Documentation for Authorities
Project Handover for Routine Manufacturing and Continous Improvement Projects
Requested Documents
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Formulation of the product
Manufacturing and packaging methods and related flow charts
Batch records
Test methods and specifications of raw materials, IPC and finished product
MSDS for raw materials
Analytical method validation reports of API and finished product
Finished product sample
Technical drawings of tablet punches
Specifications of packaging materials
Existing technical drawings of primary packaging materials and existing artwork documents of secondary packaging materials (to be evaluated and
revised)
Test methods of packaging materials
Process difficulties
Bulk holding time validation report, if available
Requested Documents
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Within the context of cleaning validation:
 Solubility information of APIs, excipients and vehicles
 Minimum therapeutic dose information of APIs
 Therapeutic category and toxicological assessment
 Existing validated cleaning procedures
 Cleaning validation reports with chemical and microbiological data
 Cleaning agents information
 Cleaning analytical methods, analytical methods for detection of API residue
(with documented evidence that the cleaning agents do not interfere with the
assay)
 Recovery studies to validate the sampling methodology
 Necessary decontamination procedures for detergents and detergent residues
Timelines
2Q-3Q 2012
July-1st week of
August 2012
June-July 2012
May-June 2012
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Confidentiality
Agreement
Procurement of
Technical Docs
Feasibility
& Pricing
Studies
Quotation and
Price Approval
Quality &
Contract Manuf.
Agreement
Filling
Product
Transfer
Info Sheet
Assesment of
Analytical
Needs
Assesment of
Tooling
Needs
Prep. of
BOM for
Production
& Packaging
Prep. &
Approval of
Artworks
Prep. & Approval
of
New Product
Notification
Purchase Order
of
Analytical Needs
Purchase Order
of
Punches & Formats
Purchase Order
of
Starting Materials
Purchase Order
of
Pack. Materials
Timelines
3Q-4Q 2012
September-November 2012
July-1st week of
August 2012
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Prep. & Approval
Of New Product
Profile
Issuance of
Change Control
Document
Prep. & Approval of
Method Tr./Val./Ver.
Protocol
Prep. & Approval of
Master Batch
Production & Packaging Records (SAP)
Method Tr. / Val. / Ver.
Prep. & Approval of
Process & Pack.
Validation Protocols
Prep. & Approval
of Method Tr. / Val. / Ver. Report
Method Transfer to QC
Prep. & Approval of Test Methods
Prep. & Approval of Stability Protocol
Procurement
of Analytical
Needs
Procurement & Release
of all
Starting Materials
Procurement of
Punches & Formats
Completion and Approval of Product Transfer Action Plan
Timelines
4Q 2012 – 1Q 2013
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February 2013
Dec 2012-Jan 2013
Completion and Approval of Product Transfer Action Plan
Production* and Analyses
of
Validation Batches
Packaging of
Validation Batches
Sampling for
Stability Studies
Prep. & Approval of
Process Validation Reports
Prep. & Approval of
Pack. Validation Reports
Stability Test and Reports
in Due Time
* Participation of MAH (Marketing Authorization Holder) for the 1st production
Preparation of Required Documentation for Authorities
Project Handover for Routine Manufacturing and Continous Improvement Projects
Contact Info
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Project Team
Contact
Persons
Title
E-mail
Ext*
Ms. Ayşen Güven
Business Development Manager
aysen.guven@pharmavision.com.tr
2025
Ms. Buket Hekiman
General Manager Assistant
Product Transfer
buket.hekiman@pharmavision.com.tr
2020
Ms. Nazlı Kuş
General Manager Assistant
Product Transfer
nazli.kus@pharmavision.com.tr
2017
Mr. Murat Atakan
Finance & Supply Chain Director
murat.atakan@pharmavision.com.tr
2010
Ms. Zeynep Bodur
Quality Operations Manager
zeynep.bodur@pharmavision.com.tr
2601
Ms. Zafer Set
Quality Assurance Manager
zafer.set@pharmavision.com.tr
2610
Ms. Emine Demiryürek
Quality Control Manager
emine.demiryurek@pharmavision.com.tr
2087
Mr. Gürkan Çolakoğlu
Production Manager
(Solids-Semi solids)
gurkan.colakoglu@pharmavision.com.tr
2051
* PhV Phone Number: + 90 212 482 00 00
PhV’s 2012 shut-down period: August 13th - September 2nd
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Production
in PhV
No compromise
from quality
Cost
savings in
overall
manufacturing
Cost & Time
savings
in terms of
logistics
Higher
profitability,
higher
productivity