In April 2006, a draft for a Standard Guide for a "Science- and
Risk-Based Approach to Qualification of Biopharmaceutical and
Pharmaceutical Manufacturer Systems" was published. This draft can
now be commented, and an introduction describes the hitherto received
evaluated comments. In the following we have summarised the introduction.
It is the aim of this Standard Guide to define a framework for the
qualification of manufacturing equipment and auxiliary systems including
their controls. Four areas can be identified among the comments that have
already been sent in:
- What is the most suitable role for the Quality Unit within the
framework of qualification?
- How should the Standard Guide address "installation and
operational verification"?
- How should the Standard Guide address "design
review/qualification"?
- How should the Standard Guide handle changes during the project
through qualification?
Re 1) The evaluation of the comments indicates the role of the Quality
Unit in seven points.
Re 2) The introduction provides very interesting aspects since it
continues the present industry trend to work off qualification aspects
within the framework of Good Engineering Practice (GEP) and
"Commissioning".
By GEP, the Standard Guide understands established engineering methods
and standards implemented during the project life cycle.
"Commissioning" is considered to be a well-planed, -documented
and -conducted engineering approach within the framework of the start-up
until turn-over to the user of facilities, systems and equipment - with
the result of a safe and functional environment meeting the specified
design requirements and the user expectations.
IQ and OQ should place special emphasis on critical elements. The text
mentions expressly that industry sees IQ and OQ in a formal light and,
therefore, their effectiveness and flexibility are curtailed and
qualification activities, not used as a normal part of installation or the
start-up phases. Many comments even consider IQ and OQ as optional or in
the sense of a final audit of GEP and commissioning. Three subtopics
present options for IQ and OQ.
Re 3) Emphasis is put on the participation of the Quality Unit in the
identification and classification of risks. The document also refers to
ICH Q9 (risk management). The result of such activities is a list of
critical elements (components, functions, etc.) leading to installational
and functional inspections as well as to tests within the framework of
GEP/commissioning. The comment suggests that this list of critical
elements and the final review of this list by the Quality Unit be named "Design Qualification". Another discussed proposal for the name of this list is "Equipment Suitability Requirements". The work group points
out that "Design Qualification" could lead to unnecessary work regarding pre-approved DQ protocols.
Re 4) The introduction suggests two kinds of change systems. Starting
from manufacture for human use, changes with QA release should be
mandatory. For all other cases, a project change management as part of the
project quality plan is recommended. This plan is released by QA.
Result:
The Standard Guide picks up the present industry trend for the
implementation of qualification activities in GEP/commissioning and
develops it in a consistent and far-reaching way. Up to a point where
independent IQ and OQ activities can be left out. One suggestion reduces
the DQ to a list of critical elements and their final review. Changes are
divided into project-related changes and changes within the framework of
manufacturing for human use.
The ASTM Guide is still a draft (2nd version). The draft
can be commented via the different interest groups and pharmaceutical
associations. Member of the European Compliance Academy can download the
document from the ECA Members Area and hand in comments. Click
here to get to the members area.
Author:
Sven Pommeranz
On behalf of the European Compliance Academy
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