Effective project management is an invaluable competency in a successful outsourcing relationship. Catalent Pharma Solutions,
SAFC, and Neuland Laboratories, offer examples of successful project management, respectively in blow/fill/seal operations,
viral-product manufacturing, and real-time project management in API manufacturing.
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Project management underpins successful relationships between contract technology and service providers and their sponsor
companies. As pharmaceutical companies increase their level of outsourcing, it becomes increasingly important for contract
technology and service providers to provide not only the technical capabilities 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. Participating in this technical forum on project
management are Norman Weichbrodt, strategic account manager at Catalent Pharma Solutions; Nick Johnson, marketing manager
at SAFC; and Saharsh Rao Davuluri, president of contract research at Neuland Laboratories.
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 solutions.
Effective project management is the cornerstone of being a complete provider of services ranging from development 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 pharmaceutical customer to transfer an ophthalmic product approved for sale
in Europe to Catalent's blow/fill/seal (BFS) manufacturing site in Woodstock, Illinois. The successful technical transfer
of the manufacturing process for this product would potentially lead, following FDA approval of the product already 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
- Designing, building, and qualifying an automated formulation 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 manager 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 Catalent'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 involving the renovation of the filling suite, making use of contractors from design through construction and qualification.
He also participated in the design and construction of the formulation skid, primarily focusing on the software development.
The development scientist and the operations 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 qualification, operational qualification), and product
qualification protocols and had oversight of all factory acceptance testing (FAT) and site-acceptance (SAT) activities. The
technical 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 specifications, 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.
