PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 274

steps listed in Figure 11.2 and others listed in Figure 11.1 were assessed and
the potential risks identified are discussed later. In addition, a list of potential
hazards and harms is included in Appendix I.
11.2.1 Raw Materials
11.2.1.1 Materials Management The risk assessment needs to start at the
beginning of the manufacturing process. The first area considered here is incom-
ing materials. The quality of the materials that will be used in the manufacture
of a finished product needs to be assessed and protected starting at the receiving
dock. There are at least three areas that require assessment.
One area is the physical examination of the materials when they are deliv-
ered to the receiving dock. What are the risks to quality under the following
conditions?
• No one is checking to see that incoming materials are properly identified.
• Packaging is not intact to protect the contents from tampering or contami-
nation.
• Packaging is not clean and dry.
• Proper storage conditions such as temperature or humidity were not main-
tained in transit as needed.
The other area is the physical protection of the materials once delivered. There
are inherent risks to the quality of the materials if warehouse staging and storage
areas are under the following conditions:
• not physically protected from ingress of environmental elements such as
rain, wind, and possibly insects, birds, or rodents;
• have standing water that can invite the proliferation of mold; and
• have poorly defined material handling procedures that are not designed to
protect the materials and their packaging from damage or contamination
during warehouse storage operations.
Where materials have certain temperature or humidity requirements to main-
tain quality, such as a refrigerated temperature or controlled room temperature,
the assessment will need to address whether there are adequate mechanisms in
place or needed to maintain and monitor the storage conditions.
Lastly, there are risks involved if the materials are not properly handled accord-
ing to their “release” status. Typically, the same storage facility is used to store
both incoming materials and finished product in the quarantine, released, and
rejected stage. For incoming materials, an apparent risk is the unintentional use
of rejected materials to manufacture finished product. For finished products, the
apparent risk is the inadvertent distribution of rejected products to the market.
The risk assessment would include whether there are adequate systems in place
to properly identify the status of materials (i.e., quarantine, released, rejected),
segregate materials according to their status as needed, and ensure only released
materials are sent to the production line or products to market.