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This article
provides an Cleaning Validation for the 21st
overview
of an ISPE Century: Overview of New ISPE
Cleaning Guide
currently under Cleaning Guide
development.
The Guide
will provide a by Andrew Walsh
framework for a
scientific, risk-
based approach
to cleaning
processes and
validation. Introduction
I
which necessitates the investment of signifi-
SPE and representatives from the phar- cant resources and time. From a simple project
maceutical industry have entered into a management analysis, the time that would be
partnership to jointly develop a science- and required to perform cleaning validation runs for
risk-based approach for the prevention of a non-dedicated facility with multiple products,
cross contamination that will, on a case-by-case pieces of equipment, and cleaning procedures
basis, determine the scope and degree of clean- can easily run into years. Considering that clean-
ing validation. ing runs cannot be scheduled and performed
This new ISPE Guide, Science and Risk- every day and the need for supporting activi-
Based Cleaning Process Development and ties including method development, protocol
Validation, will describe how to implement development, laboratory analysis time, and
cleaning programs, using science- and risk- report writing, cleaning validation can consume
based approaches, in accordance with the new considerable time and resources.
principles promulgated in ICH Q7 to Q10,1 Companies have made various efforts to
FDAs cGMPs for the 21st Century,2 FDAs PAT reduce the amount of time and resources,
Initiative,3 FDAs Process Validation Guideline,4 such as dedicating equipment or converting to
as well as the statistical approaches of Six disposable items. These strategies have other
Sigma and Operational Excellence. The Guide inefficiencies and costs associated with them.
will also describe how to implement cleaning Even with such efforts, part of the reality has
programs that maintain compliance with FDA, been that, for all intents and purposes, clean-
EMEA, and MHLW regulatory expectations. ing validation never seems to be completed.
A global team of cleaning, cleaning validation, This emphasizes that a useful, effective, and
quality assurance, toxicologists, and Six Sigma efficient cleaning program cannot be developed
professionals representing API, clinical, phar- without focusing efforts and resources where
maceutical, and biological manufacturing, as they provide the most value.
well as FDA representatives has been assembled With appropriate cleaning development
to develop this Guide. and risk assessments in place, a streamlined
cleaning program may be readily developed
Background that is both science-based and risk-based while
Cleaning validation is a required activity within ensuring patient safety and product quality.
the pharmaceutical, biological, nutritional Pharmaceutical manufacturing is in a
supplement, and medical device industries. dramatically revolutionary time in its history.
From both a regulatory and industry stand- There have been many new, and for this highly
point, cleaning validation is recognized as an conservative industry, radical movements over
important activity to establish that product the past few years from both regulators and
cross contamination is controlled to ensure within the industry itself. Examples coming from
patient safety and product quality. the FDA include GMPs for the 21st Century,
Cleaning validation is an ongoing activity Quality by Design (QbD), Process Analytical
within these cGxP compliant environments Technology (PAT), and the new Guideline on