Facility Qualification

To provide guidelines for checking facility construction and finishing to ensure that they meet the facility design qualihcation requirement 

It is the responsibility of all concerned managers and contractors to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

The conceptual design of the facility (approved civil layout) should be available and be compared with the actual construction. Details should be summarized in a tabular form describing  

The quality of materials used shall be confirmed from the purchasing specification and the materials receiving reports. Generally, the use of wooden materials is not recommended. 

Epoxy resin-welded PVC sheets and epoxy terrazzo are generally recommended. 

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The purpose of area and facility qualification is to demonstrate that the area and facility meet the design qualification requirements for temperature, humidity, viable, and nonviable count. 

Facility Qualification a) Any alteration in area specification b) Sanitization procedure or frequency change Area Qualification QA + Concerned dept, managers... 

The first edition comprised Val. Section 200 to Val. Section 1300, providing 75 validation SOPs covering design qualification, utilities qualification, facility qualification, equipment qualification, training needs, and major sterile and nonsterile operations-related equipment. 

Once the manufacturing projection questions have been answered, a manufacturing philosophy must be decided on. This includes deciding on documentation requirements, special materials handling, controlled substance security, cleaning validation criteria, and equipment and facility qualification requirements. Now that we know what types of batches are to be manufactured, we can be more detailed in the description of the requirements of the facility. These requirements may be based on internal as well as regulatory requirements. In fact, if a full-scale facility is already in place, this step can be completed fairly easily and quickly. Many of the policies and systems may be transferred directly into the pilot facility. And others may be transferred with only slight modifications. 

As part of the planning part of the project, an evaluation of the cleaning requirements for both the equipment and the facility must be done. An overall plan must be outlined for the evaluation of the success of the team. This success may be measured by the results of the equipment and facility qualification. What criteria will we use to qualify our construction and installation The answer to this question will allow us to tailor our activities so that we can remain focused on the task at hand. 

DeSain, C., Sutton, C. Facility qualification studies. Biopharm 38-41 (Jan. 1998). 

Sound development package in place Ranging studies completed and documented Facility qualification completed and documented Equipment qualification completed and accepted Appropriate analytical methodology implemented and validated Personnel training completed and documented Process trials and demonstrations executed and documented Change control in place and effective... 

Sampling Plans Raw material/ component qualification Analytical methods Equipment/ facility qualifications... 

To successfully identify and select clinical investigators, the sponsor s representatives need to identify internal and external sources for potential investigators define investigator selection criteria, protocol requirements, expected cost of the study, and investigator and facility qualifications interview potential investigators and, finally, schedule and conduct prestudy site evaluation visits. 

The author would like to acknowledge the cooperation and support of colleagues at Aventis Behring GmbH, Marburg. In particular Mr. Mathias Klein, Director of Facility Qualification, for his council and direction and Mr. Maurice Shakeshaft of CB Automation Ltd, who assisted in the preparation of the English version of this chapter. 

To limit the potential for deficiencies to escape detection before the product is released, special processes should be documented in the form of procedures and specifications that will ensure the suitability of all equipment, personnel, and facilities, and prevent varying conditions, activities, or operations. Qualification in the context of special processes means that you need to conduct a thorough assessment of the processes to determine their capability to maintain or detect the conditions needed to produce conforming product consistently. The limits of capability need to be determined and the processes only applied within these limits. In qualifying the processes you need to qualify the personnel using them by training and examination as well as the materials, equipment, and facilities employed. It is the combination of personnel, materials, equipment, and facilities which ensure qualified processes. 

In production you need to ensure that only those personnel, equipment, materials, and facilities that were qualified are employed in the process, otherwise you will invalidate the qualification and inject uncertainty into the results. If subcontracting special processes you need to ensure that the subcontractor only employs qualified personnel and has qualified process equipment and facilities (see Part 2 Chapters 6 and 18). 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

The validation of ne v facilities, systems or equipment is usually accomplished using a four-stage process of design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). 

Design qualification is of most relevance for systems that involve custom-design such as the facilities themselves, vhere it is necessary to demonstrate that the design complies vith GMP requirements. For simpler off-the-shelf equipment it is usually only a matter of selecting the correct equipment for the intended use. 

During the development stages, we needed to go several times for testing into the OEM s sophisticated qualification labs, tucked deep within their awesome production facility in Singapore. And that s where the real switch used to happen. Read on ... 

Design qualification Auditing the design of a facility (or element of a facility, such as a cleanroom) to ensure that it is compliant with the specifications laid down and that it is, therefore, capable of meeting GMP requirements... 

A policy statement alone is worth very little. Management must provide a sustained commitment of resources for an ongoing program. The most important resources are the right people having the background, qualifications, experience and commitment needed to safely operate and maintain the facility. This includes the technical expertise to understand chemical reactivity hazards and their control and the means to maintain the needed knowledge over time. 

Determine hiring qualifications or training requirements for understanding of chemical reactivity hazards at facilities where such hazards must be controlled, appropriate to the nature of the hazards... 

Personnel Qualifications Personnel Hygiene Consultants Buildings and Facilities Design and Construction Utilities Water... 

Design Qualification (DQ) This provides documented verification that the design of the facilities, equipment, or systems meets the requirements of the user specifications and GMP. 

It is important that the outside service company meet the facility pre-qualification criteria. As part of the selection process, it must be determined if the service company is knowledgeable and experienced in the types of fire protection systems they will be designing, installing, or maintaining. 

Before any fire protection service company is selected to perform inspecting, testing, and maintenance on fire protection systems at the facility, they should be qualified. The service company qualifications may include ... 

The level of qualifications for personnel expected should be specified in the bid package or purchase order. The facility should require the service company to provide evidence that the personnel performing inspections, testing, and maintenance meet the qualifications. Safe work procedures should be extended to all service company personnel. 

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