eBook: TOC and Microbial Detection Monitoring - 10

White Paper

THORNTON
Leading Pure Water Analytics

Simplifying the Regulations
for TOC in Pharmaceutical Waters

Pharmaceutical manufacturers are faced with an evergrowing list of resources that aim to define or assist
with the interpretation of regulatory guidance. It is
critical to understand how these resources apply to
specific parameters, analytical instruments, and
analytical methods when defining the approach for a
given manufacturing process. This paper brings clarity
to the applicability of these resources, with a specific
example demonstrating a method for continuous
Total Organic Carbon (TOC) monitoring of Bulk
Pharmaceutical Waters.

ceuticals and Medical Devices Agency (PMDA), and the
relevant pharmacopeias globally have differing requirements for analytical parameters and their application. This
complicates the decision making process when determining a control protocol for a parameter.

Introduction
Two key challenges for today's pharmaceutical manufacturers are the extensive globalization of the pharma market,
and the need to address the requirements of numerous
governmental regulating bodies. Organizations such as
the European Medicines Agency (EMA), Food and Drug
Administration (FDA, USA), State Food and Drug
Administration (SFDA, China), the Japanese Pharma-

The International Council on Harmonization (ICH),
although not a regulatory body, aims to provide harmonized guidance between the EMA, FDA, and PMDA.
However, information from the ICH may create confusion,
and give the perception that additional steps are necessary
for qualification of measurements when this material is
taken out of context of regulatory requirements stated
directly within the pharmacopeias.

Further difficulty in understanding the requirements results
from the use of language intended to prevent regulations
from becoming too restrictive for users: the purpose being
to enable a manufacturer to take into account their own
specific applications, risk evaluations, and use-cases.
eBook: TOC and Microbial Detection Monitoring

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