PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 116

9. Equipment

dirty

Failure of
cleaning
procedures

Contamination/
cross-
contamination

• Develop detailed cleaning
procedures and TOC for
verification at product
changeover. At present there
is no changeover because
single API used

Risk acceptable—detailed
documentation of line
clearance and equipment
cleaning before GMP
production

YES

10. Equipment

malfunc-
tions

Equipment
defective

Faulty product Risk acceptable YES

• Qualify critical equipment/
items
• Calibrate critical
instrumentation
• Procedures for malfunction
handling including
assessment of potential
product impact

11. Materials
unsuitable

Animal sourced
materials

TSE/BSE Risk acceptable YES

• Manufacturers identified (not
just suppliers) so that supply
chain is transparent
• Certificates of suitability
obtained

( continued )