PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 272

Manufacture of a solid product

Raw materials

Storage Finish processing Formulation

Dispensing

Materials
management
API/excipient/
water quality
Supplier
management

Materials
management

Compression

Granulation
Drying

Film coating

Branding

Milling

Packaging

Blending

Solid product

Environmental control

Training Validation

Maintenance/
calibration
Cleaning/storage

Interventions Cleaning

Materials flow

Protective gear

Fit for use

Hygiene

Facility

People Equipment

Figure 11.1 Example of a cause and effect diagram showing the manufacture of a solid
product. ( See insert for color representation of the figure .)

At first it may be best to start out by identifying all the manufacturing steps
and inputs for a particular product. There are tools that can help. For example,
one tool is a cause and effects diagram also known as a fishbone diagram [17].
Figure 11.1 is an example of a fishbone diagram where all the processes involved
in the manufacture of a solid tablet are listed.
In this fishbone diagram, the top half of the fishbone contains the different
major steps of the manufacturing process starting with the receipt of incoming
raw materials in the warehouse (at the head of the fishbone) through the formu-
lation steps (e.g., dispense, blend), the finish process steps (e.g., compression,
packaging), and ending with the finished product storage in the warehouse (near
the tail of the fishbone). The bottom half contains components that support the
manufacturing process and would have an impact on the outgoing product quality:
facility, equipment, and people.