The qualification of equipment and machinery is performed throughout its lifecycle (see Figure 1).
Figure 1 The qualification lifecycle
The first step in a qualification is the design qualification (DQ). According to Annex 15 it is to be demonstrated and documented that the design matches the GMP requirements for the equipment.
The design qualification includes the documentation of the planning phase including the decision making process for the equipment. The DQ should define and verify the requirements for the entire unit.
The design qualification documents (see Figure 2) include the requirements of the user regarding the equipment and services to be delivered (user requirement specification) as well as the agreement with the supplier regarding the realization and execution of the project (functional design specification).
Figure 2 Design qualification (DQ) contents
Before acquisition of new equipment the drug manufacturer should identify the requirements (processes, products, performance). Various areas in the site are typically involved in the definition of the requirements which yields an informal profile of requirements for the new equipment. This profile of requirements is translated into a user requirement specification (URS). The URS should contain the requirements from the perspective of the equipment operator as well as all boundary conditions. These should be able to be qualified and tested. The URS represents the economic, technical and organisational expectations of the client placed on the equipment. The goals and purpose of the equipment are defined in the URS.
When assembling the requirements for the URS, a differentiation should be made between essential (obligatory) and desired (optional) requirements. Not all of the requests placed by the future operators can be realized in practical operation. It depends on the market situation whether equipment suppliers can be found for a specific piece of equipment and if these are able to supply the necessary quality. The services available are determined as part of a carefully executed market analysis. The result of the market analysis can make it necessary to update the previously approved URS, since new aspects may come up which impact the equipment design, which were not originally reflected.
Potentially not all suppliers on the market will be able to design and manufacture the equipment according to the principles of Good Engineering Practice. When selecting the appropriate supplier it is important to check criteria above and beyond the commercial aspects, i.e. quality aspects and capabilities. This evaluation is typically performed as part of a supplier qualification. This should include service aspects (e.g. support during qualification, operational and maintenance training, troubleshooting support) which play a role.
Those suppliers which have been deemed as capable during the supplier qualification are selected to receive the URS. The suppliers are requested to submit an FDS based on the URS to the client as part of generating a tender for the purpose of forming a purchasing contract.
Important aspects of a supplier qualification are summarized in Figure 3.
Figure 3 Aspects of an equipment supplier qualification
In the functional design specification (FDS) the user’s requirements are listed in detail and augmented by the concrete examples of how the requirements will be fulfilled. The FDS defines how and with which means the requirements will be fulfilled.
According to DIN 69901-5 the FDS includes the “description of the supplier’s developed plans for meeting the needs given in the client’s URS”. The requirements given in the URS are linked with the technical requirements for the operating and maintenance environment.
According to the VDI Guideline 2519 Blatt 1, the FDS is the description of how all customer requirements listed in the URS will be met.
In general a design is regarded as qualified when the FDS meets the needs in the URS. The documented comparison between the FDS submitted by the supplier and the URS provided by the pharmaceutical manufacturer should lead to the result that at least the mandatory requirements are fulfilled.
This text is an excerpt from the GMP Series Download Qualification and Validation: Agency Expectations
The ultimate prerequisites for GMP-conform pharmaceutical manufacturing are validated processes and qualified equipment! Qualification and validation should prove that the equipment, the procedures and processes used during the manufacture of medicinal products are suitable for their purpose. Previously defined acceptance criteria for the critical quality attributes and process parameters have to be met reproducibly.
This sounds plausible. However, the practical implementation raises many questions. How do you correctly use risk management? By what means can the life cycle concept be realised? How do you organise planning, performance and documentation efficiently and in a GMP-conform manner? And most important of all, what are the expectations of the responsible authorities?
In this report Michael Hiob provides all the answers. It is a “must have” guidance for all those who are involved in qualification and validation
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Michael Hiob, PhD
Ministerial Pharmaceutical Director
Ministry of Social Affairs, Kiel