Incoming Materials Check - US Pharmacopeia (USP)
APEC AHC ¨C USP Center of Excellence (CoE) for Product Quality & Supply Chain
Pilot Program: ¡°Securing Medical Product Quality Through the Supply Chain¡±
Incoming Materials Check
Ong Kang Teng
Health Sciences Authority of Singapore
28 March 2017
Licensed &
inspected for
compliance
to local
regulation &
standards
DEG Contamination
US FDA presentation by Edwin Rivera-Martinez, June 2010
Formulation of Acetaminophen cough Syrup
Active
Ingredient
Excipients
If you are a Acetaminophen Syrup Manufacturer
Source for
starting
materials
? Acceptable
quality
attributes
? Approved
supplier
? Contract
agreement
Registration of
starting
materials &
product
? Specification
? Analytical
method
Validation
? Approved
Supplier
? Process
validation
................
................
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