BIOPHARMACEUTICAL MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 324

risk ranking tool can be used to establish the priorities with which suppliers are
audited for compliance to standards [2]. Thus, animal-derived raw materials being
used in parenteral products would be expected to assume a higher priority than
non-animal-derived raw materials or materials intended for use in topical appli-
cations. Similarly, suppliers having a spotty compliance history may be subject to
closer scrutiny than those who have a “cleaner” compliance record. Prioritization
for follow-up activities may be established using relative risk ranking tools or
checklists.
Supplier quality programs typically assess a supplier's quality system includ-
ing the compliance with GMPs, nonconformances, process changes, validation
issues (method and process), etc. These assessments provide a window into sup-
plier processes and can provide an early warning of problems associated with raw
material quality. Given this early warning, a company may be able to work with
their suppliers to establish mitigations and alleviate potential problems before
they occur.
Managing suppliers and cold chain issues are important to assure the quality of
raw materials. Vendor experience often dictates the frequency of vendor audits. In
selecting vendors it is important to consider their financial status, their experience
with a particular raw material, the geographic proximity to the manufacturing
sites and to whom the supplier provides materials, multiple industries, or just the
pharmaceutical industry. Risk may be minimized by qualifying multiple suppliers
to avoid reliance on a single source of materials.
Supplier agreements should include provisions for oversight of change con-
trol processes such that manufacturers are notified of changes to a supplier's
manufacturing processes.
Including impact assessments in such agreements provides a ready form for
making decisions relative to the importance of changes to material quality.
Risk assessments for suppliers should focus on material quality and avail-
ability. A nine-block assessment tool can be used to integrate information about
supplier performance and material risk into a single risk ranking. The ranking
can then be used to establish supplier controls and audit frequencies. An example
of a nine-block assessment tool is shown in Figure 12.3.
As seen in the nine-block tool in Figure 12.3, the degree of control exerted over
a supplier is directly related to the risk associated with an individual material and
the overall performance of the supplier. Thus, a marginal supplier who provides a
high risk material would require much greater control than a best-in-class supplier
providing a material having a similar risk characterization.
Raw materials must be traced by suppliers to their country of origin. Risk
assessments should be reviewed periodically and should include lessons learned
from past experiences. It is highly recommended that they be updated to reflect
current knowledge and changing conditions relative to the supplier.
12.3.1.2 Quality Risk Management for Raw Materials The major risks asso-
ciated with the raw materials management are discussed in the following section.