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TECHNICAL TRANSFER DOCUMENTATION IS KEY FOR SUCCESS Tom Hughes, Technical Services Manager

Abstract: Clearly defined objectives and project requirements between the pharmaceutical company and their contract packager need to be spelled out – in writing – in a Technical Transfer Document prior to any pharma packaging project. A published report documenting details for the customer and the packager is a critical component for success.

Company: Service-Packaging Insights

Contract packagers for the pharmaceutical industry are entrusted with the customer’s future and success, whether it is a virtual company depending entirely on the contract packager for packaging services or a top five big pharma company looking for additional capacity.

The contract packager’s success depends on the ability to deliver the customer’s product on time and on meeting all of their quality requirements at a price that maintains acceptable margins for the customer while providing sufficient profits to grow the packaging operation.

To ensure these objectives are met, there must be clearly defined requirements. Developing and understanding these requirements begin with the initial customer contact and continues until these requirements are documented and approved.

For CS-PI, this is achieved through the Technical Transfer process. The initial data gathering occurs with the customer during the quoting process when the basic packaging requirements are communicated.

To fully define the project requirements, it is important to understand the customer’s objectives. There are a number of questions that must be answered early in the project to begin understanding the scope of the work to be done. Does the project provide for a new product launch or re-launch or the transfer of an existing SKU that is being moved to the contract packager without change? What is the timing of the project? How quickly must product be available to the distribution center? What is the scope of the packaging project, and is it primary and secondary packaging or secondary packaging only?

When a project is quoted and that quotation is accepted, it is based on the data available at the time of the Request for quotation, or RFQ. To capture all of the critical information for packaging of the product, it is essential that a Technical Transfer document be created.

Key elements of the project must be understood and agreed upon for the customer’s expectations to be met and for the packager’s goal of successfully fulfilling the customer’s needs from their contract packager. The key elements of the Technical Transfer are discussed with the client prior to the document development, either through a face-to-face meeting, video conference or teleconference. Each element is addressed in this .

Purpose/Scope

The purpose and scope of the Technical Transfer must be clearly defined. The Technical Transfer should detail the product type, the packaging configuration and the packaging services required to successfully fulfill the customer’s requirements. This document does not supersede the purchase order, any quality agreements or supply agreements, but rather complements these documents to ensure all objectives are understood.

Scope of Work

Different from the purpose and scope, this section of the Technical Transfer addresses each finished good that is to be produced. The scope of work will document what materials will be used in the packaging, who will supply them, who has responsibility for supplier approval and how bulk or semi-finished goods (designated for secondary packaging) will be received. The processing steps associated with the packaging process will be flow charted to ensure that all aspects of the process are understood both internally and externally.

It is during the scope of work development that any deviations from what was quoted and what will be delivered are discovered. It is also during the documentation of this section that any additional requirements that were not previously considered are captured before proceeding.

Documentation Requirements

Contract packagers, by their natural extension of the NDA holder or customer, are obligated to meet all of the regulatory requirements of the customer and any special considerations required by the customer. Part of having clear requirements is detailing the specifications for components used (whether purchased or client-supplied), bill of material requirements and definition of release requirements for these components.

Pharmaceutical contract packaging is necessarily a document laden industry. These documents are the objective evidence provided to regulatory bodies upon request documenting compliance with the current regulations.

Packaging Specification

The requirements for the packaging specification are clearly defined in this section. These include step-by-step instructions that communicate to the customer and to the Operations personnel the requirements for the packaging process. These become the base document for the packaging record that is developed for the customer’s product.

This section may be enhanced by including digital photographs to provide clarity for more complex processing steps or specific requirements for the package and how they will be met. As with the scope of work, this portion of the technical transfer will expose any deviations from the quotation and the packaged product requirements. Many times, a quotation will be based on the data available at the time of quoting; the Technical Transfer will ensure that the requirements of the RFQ are consistent with the deliverables for the project.

Any special requirements for the product are detailed in this section, including requirements for stability samples, retain samples, safety considerations and any special storage or handling requirements. The requirements for product shipment, including height restrictions or dedicated or refrigerated truck, should be detailed to ensure these expectations are met.

Including diagrams of pallet patterns, theoretical weights and pallet weights will assist the customer in communicating with their distribution centers.

Validation Requirements

All validation requirements for the project are detailed to communicate to the customer what the expectations are for developing a reproducible project. This is especially true for projects when the packaging components or package design do not fit within the already validated matrix for the equipment or process.

This will include all requirements for installation qualification, operational qualification and performance qualification documents to support the packaged product. The scope of the validation depends on the complexity of the process, the equipment required and any product- specific tooling that is used to complete the packaging.

In-Process Controls

It is critical to define the quality expectations for the packaged product. This requires that defect classifications be agreed upon at the beginning of the project.

Deviations from the standard will occur during packaging operations. The tolerance any single customer has to those deviations (defects) must be documented, including the acceptance criteria used to assess quality during in-process inspections. Attaining this agreement during the project inception will ensure that issues associated with product quality are resolved quickly, as delays associated with deviations can disrupt the product supply chain.

Document Approvals

The Technical Transfer should be developed with and approved by the customer’s representatives including, at a minimum, the Quality Control Unit, the Operations Management Unit, the Regulatory Compliance Unit and the Supply Chain Management Unit. A published Technical Transfer report should be supplied not only to the customer but also to the contract packager’s internal teams prior to the project’s inception.

There are times, based on the complexity of the project, that other groups from the customer be involved and approve the document. These could include marketing, technical services, validation, project managers and product managers. The contract packager should include, at a minimum, approvals from the Quality Control Unit, Procurement, Technical Services and Operations.

The success of any contract packaging project is dependent on the communication between the packager and the customer. Documenting those requirements in a Technical Transfer – and later translating those requirements into formal specifications – ensures that there are no surprises during project execution.

It has been said that “no one remembers how fast they got it if it isn’t right.” Clearly defined requirements as detailed in the Technical Transfer are the first step in ensuring all three aspects of the packaging project are met: Quality, Delivery and Price.