ASTM Draft Guide: Science- and Risk-Based Approach to Qualification

GMP News No. 729

GMP News
17 May 2006

ASTMDraft Guide: Science- and Risk-Based Approach to Qualification

In April 2006, a draft for a Standard Guide for a "Science- andRisk-Based Approach to Qualification of Biopharmaceutical andPharmaceutical Manufacturer Systems" was published. This draft cannow be commented, and an introduction describes the hitherto receivedevaluated comments. In the following we have summarised the introduction.

It is the aim of this Standard Guide to define a framework for thequalification of manufacturing equipment and auxiliary systems includingtheir controls. Four areas can be identified among the comments that havealready been sent in:

  • What is the most suitable role for the Quality Unit within theframework of qualification?
  • How should the Standard Guide address "installation andoperational verification"?
  • How should the Standard Guide address "designreview/qualification"?
  • How should the Standard Guide handle changes during the projectthrough qualification?

Re 1) The evaluation of the comments indicates the role of the QualityUnit in seven points.

Re 2) The introduction provides very interesting aspects since itcontinues the present industry trend to work off qualification aspectswithin the framework of Good Engineering Practice (GEP) and"Commissioning".

By GEP, the Standard Guide understands established engineering methodsand standards implemented during the project life cycle."Commissioning" is considered to be a well-planed, -documentedand -conducted engineering approach within the framework of the start-upuntil turn-over to the user of facilities, systems and equipment - withthe result of a safe and functional environment meeting the specifieddesign requirements and the user expectations.

IQ and OQ should place special emphasis on critical elements. The textmentions expressly that industry sees IQ and OQ in a formal light and,therefore, their effectiveness and flexibility are curtailed andqualification activities, not used as a normal part of installation or thestart-up phases. Many comments even consider IQ and OQ as optional or inthe sense of a final audit of GEP and commissioning. Three subtopicspresent options for IQ and OQ.

Re 3) Emphasis is put on the participation of the Quality Unit in theidentification and classification of risks. The document also refers toICH Q9 (risk management). The result of such activities is a list ofcritical elements (components, functions, etc.) leading to installationaland functional inspections as well as to tests within the framework ofGEP/commissioning. The comment suggests that this list of criticalelements 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 pointsout that "Design Qualification" could lead to unnecessary work regarding pre-approved DQ protocols.

Re 4) The introduction suggests two kinds of change systems. Startingfrom manufacture for human use, changes with QA release should bemandatory. For all other cases, a project change management as part of theproject quality plan is recommended. This plan is released by QA.

The Standard Guide picks up the present industry trend for theimplementation of qualification activities in GEP/commissioning anddevelops it in a consistent and far-reaching way. Up to a point whereindependent IQ and OQ activities can be left out. One suggestion reducesthe DQ to a list of critical elements and their final review. Changes aredivided into project-related changes and changes within the framework ofmanufacturing for human use.

The ASTM Guide is still a draft (2nd version). The draftcan be commented via the different interest groups and pharmaceuticalassociations. Member of the European Compliance Academy can download thedocument from the ECA Members Area and hand in comments. Clickhere to get to the members area.

Sven Pommeranz
On behalf of the European Compliance Academy


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