Page 59 - Assurance of Sterility for Sensitive Combination Products and Materials

Aseptic processing 47

production needs of the operation. This would include the type of products
and therapies, annual production output required, rate of output, number of
products, global regulatory requirements, flexibility and redundancy busi-
ness strategy, cost strategy, and production timing.
The quality aspects of the product might be contained in a quality tar-
get product profile (QTPP). The QTPP is a prospective summary of the
quality characteristics of a drug product that ideally will be achieved to
ensure the desired quality, considering the safety and efficacy of the drug
product [10, 11].
The business objectives of the production process must also be known.
This information is often noted in what is referred to as a project charter.
The project charter includes such information as:
• annual or periodic production quantities,
• critical quality attributes of the product,
• supply chain considerations, and
• patent or approval timing issues.
A useful tool to capture and summarize the aseptic processing strategy is
the LOS Evaluation Table (Table 4.1). This tool links the quality attributes
as defined to the process steps and identifies how the process will be con-
trolled, monitored, and documented.

4.8 Basis of design
The basis of design defines the limitations and requirements to meet the
objectives of the manufacturing operation and process. These limitations and
requirements may be driven by questions related to technical, regulatory, mar-
ket, cost, safety, business, or other concerns and circumstances. For example:
• Is the product inherently sterile or can it be sterilized by filtration or by
some other means?
• Is the product sensitive to air, light, or temperature?
• Can the product be sheared or damaged through the filling process?
• Will the product react to manufacturing and fill system materials of
construction, such as metals, stainless steel, plastics, etc.?
• Must the product be lyophilized for functionality or stability?
• Does the product involve autologous and allogeneic cell collection?
• Does the product have special or unusual holding, storage, collection, or
transport requirements?
• Is the product hazardous, hypoallergenic, or requires containment
considerations?