The project required the following: • A complete renovation of a formulation and filling suite, including a new separate air-handling system Case Studies in Pharmaceutical Project Manage
Trang 1The Authority on Drug Development & Manufacturing
PharmTech.com
2012
Supplement to the February 2012 Issue of
PREFERRED
PROVIDERS
Finding the Right Partner
Trang 2s2 Pharmaceutical Technology P h a r mTe c h c o m
Project Management
Project management underpins successful
relation-ships between contract technology and service pro-viders and their sponsor companies As pharmaceuti-cal companies increase their level of outsourcing, it becomes increasingly important for contract technology and service providers to provide not only the technical capabili-ties needed to execute a given project, but the management skills to deliver a project on time, to specifications, and with the necessary communication to prevent or mitigate project delays To illustrate the importance of project management in outsourcing, several industry members provided case studies
on how to coordinate, organize, and implement a successful project
Blow/fill/seal manufacturing
Norman Weichbrodt, strategic account manager at Catalent Pharma Solutions
Catalent Pharma Solutions is a provider of drug and biologic development services, delivery technologies, and supply so-lutions Effective project management is the cornerstone of being a complete provider of services ranging from devel-opment of new products to technical transfer of existing products Building the proper project team and employing the correct methodology for handling a complex project is the foundation on which success is achieved
In July 2010, Catalent was approached by a major pharma-ceutical customer to transfer an ophthalmic product approved for sale in Europe to Catalent’s blow/fill/seal (BFS) manufac-turing site in Woodstock, Illinois The successful technical transfer of the manufacturing process for this product would potentially lead, following FDA approval of the product al-ready made in the European facility, to approval of the drug for manufacture and sale in the United States
Project scope The actual scope of this project was much larger for the Woodstock facility than a simple technical transfer The project required the following:
• A complete renovation of a formulation and filling suite, including a new separate air-handling system
Case Studies in Pharmaceutical Project Management
A Technical Forum
Moderated by Patricia Van Arnum
Effective project management is an invaluable
competency in a successful outsourcing
relationship
Trang 3• Designing, building, and qualifying an automated
for-mulation skid
• Upgrading an existing BFS filling machine to match the
capacity requirements for the product
• Designing, building, and qualifying new vial molding
and filling systems to duplicate the existing European
design
• Qualifying the room, formulation skid, BFS machine,
and secondary packaging to produce stability and
process-validation batches to support the customer’s
submission and approval timeline
• Developing and approving the required documentation
for supply-chain, manufacturing, and quality assurance
functions to meet the production timeline
• Analytical-method transfer for chemistry and microbial
testing
• Complete process-validation protocols, test plans, and
final reports to meet the submission timeline
Cross-functional teams To manage a project of this scope,
the Catalent New Product Development (NPD) group
and the site-management team agreed to form a group of
cross-functional resources The team members served as
the primary representative of their functional area for the
project and were assigned for the duration of the project
The project team consisted of a project manager from NPD,
an engineering project manager, a development scientist,
an operations specialist, a validation specialist, a
quality-assurance product specialist, a technical writer, and various
contract resources as required A strategic account
man-ager had overall responsibility for the project team The
establishment and use of an expanded core project team of
cross-functional resources was a new approach for
Catal-ent’s Woodstock facility, but the scope and timeline for this
project and the Catalent goal of meeting customer needs
required an innovative solution
The project was divided into six major activities: the
room, the formulation skid, the BFS machine, method
transfer, secondary packaging, and documentation The
NPD project manager was the owner of the overall project
timeline Each major activity was included in a Microsoft
project schedule and maintained by the project manager
The engineering project manager handled all activities
in-volving the renovation of the filling suite, making use of
contractors from design through construction and
qualifi-cation He also participated in the design and construction
of the formulation skid, primarily focusing on the software
development The development scientist and the
opera-tions specialist focused on the design of the formulation
skid and the interface of the skid with the BFS machine to
ensure the system had the proper design and controls to
replicate the process already being used in Europe The
validation specialist developed the installatoin
qualifica-tion, operational qualification), and product qualification protocols and had oversight of all factory acceptance test-ing (FAT) and site-acceptance (SAT) activities The tech-nical writer and the quality-assurance product specialist worked with the NPD project manager to manage the change-control process for the project and to complete all the required documentation, including material specifica-tions, standard operating procedures, and manufacturing batch records The NPD Project manager also provided oversight of the analytical method transfer, development
of secondary packaging materials, and the documentation
of project activities
Technology transfer. The technology-transfer process was initiated by creating a comparability document that detailed every aspect of the manufacturing process The process used
in the European manufacture was listed step by step in the document with Catalent’s suggestions and capabilities side
by side A final agreement for each step was included and served as the approved path forward The specifications for in-process testing at each stage of the formulation as well as finished-product specifications were included in the docu-ment The formulation process required bulk sterilization
of a multicomponent polymer base with a relatively tight viscosity range Two APIs were combined in a second part
of the formulation and transferred to the polymer solution
by sterile filtration Of course, the entire formulation skid required steam sterilization of the product path through the BFS machine and maintenance of the sterile boundaries for the product during the entire filling process Electronic documentation of all temperatures, times, and controls for each process step also were also required
Communication. The NPD project manager and the stra-tegic account manager facilitated weekly calls with the original equipment manufacturers of the formulation and BFS equipment as well as construction meetings during that phase of the project Weekly calls were held with the cus-tomer representatives who were in liaison with the project team A standard methodology was used to ensure that the meetings had a structured agenda and minutes issued for review in a timely fashion A joint Project Steering Com-mittee was formed, which was comprised of customer senior leadership members, Woodstock site leadership members, and Catalent business-development members
Project Steering Committee meetings were held every three weeks during the course of the project A formal pre-sentation was made at each meeting to discuss progress toward major milestones in the project plan Strategic de-cisions were discussed and developed through the Project Steering Committee meetings, and the decisions were ulti-mately made by the joint project team This management design reduced the cycle time for critical decision-making between the customer and Catalent
Pharmaceutical Technology P h a r mTe c h c o m s3
Trang 4An example of such decision mak-ing was approval of a change to the SAT/FAT strategy originally planned for the formulation skid The formu-lation skid is a fully automated two-tank system with over 100 control and process valves that are actuated in ap-proximately 20 sequences When the software development lagged behind the construction of the hardware, the opportunity arose to do a mechani-cal FAT, ship the formulation skid
to the Woodstock site, complete the installation and mechanical trouble-shooting of the skid and wait for the software to complete the qualification
as a SAT This decision saved as much
as six weeks in the project schedule and enabled Catalent to meet the customer’s timeline for stability and process-validation manufacturing It also resulted in a formulation system that is part of a robust technical trans-fer process from the customer through the NPD group to Catalent’s commer-cial manufacturing team
Execution. To date, all of the engineer-ing, stability, and process-validation batches have met the in-process and final-product test specifications With nine batches produced, there have been
no out-of-specification results for bulk
or final product In addition, no human error deviations have occurred in the formulation and filling of these batches Figures 1–3 (Catalent) show the fa-cility upgrade and project equipment after installation
In summary, Catalent did not em-ploy new or groundbreaking method-ology for this project However, supply-ing the proper structure and resources for a project team is the crucial first step in meeting a customer’s timeline and supplying the customer with qual-ity product, reliably supplied
Figure 1 (Catalent): A blow/fill/seal suite at Catalent’s Woodstock, Illinois, facility.
Figure 2 (Catalent): A blow/fill/seal cavity fill machine at Catalent’s Woodstock, Illinois,
facility.
Figure 3 (Catalent): A fully automated formulation skid at Catalent’s Woodstock,
Illinois, facility
Project Management
Excerpted from and posted with permission from the Supplement to the February 2012 issue of Pharmaceutical Technology
Copyright ©2012, an Advanstar publication All rights reserved.
www.pharmtech.com
#C6545 Managed by The YGS Group, 800.290.5460 For more information visit www.theYGSgroup.com/content.