GMP News No. 729
17 May 2006
ASTM Draft Guide: Science- and Risk-Based Approach to Qualification
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:
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.
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.