Qualification design

Test specifications to be produced which define the features and characteristics that are to be verified for design qualification and acceptance... 

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. 

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... 

Buttweld fittings manufactured in accordance with ASME B16.9 may be trimmed to produce an angular joint offset in their connections to pipe or other buttweld fittings without being subject to design qualifications in accordance with para. IP-3.8.2, provided the total angular offset produced between the two jointed parts does not exceed 3 deg. 

A. When developing a dissolution method, the design qualification is built into the apparatus selection process. The dosage form and delivery system process will dictate at least initially the equipment of choice. For example, the first choice for a beaded product may be United States Pharmacopeia (USP) Apparatus 3, which is designed to confine the beads in a screened-in cylinder. 

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. 

Drug Master File deoxyribonucleic acid design qualification effective dose... 

Instrument qualification or validation refers to the process of demonstrating an instrument s suitability for its intended use. The first step is to write protocols to cover the four main qualification elements design qualification, installation qualification, operational qualification, and performance qualification. Another qualification element, re-qualification, can be written as a separate protocol or included as part of the PQ protocol. These protocols must be performed in sequence. If the protocol meets its acceptance criteria, then the next protocol in the sequence can be executed. 

Design qualification (DQ) is the process used to determine a system that will function within the intended purpose. It can be compared to a user s requirements document for a piece of software. For example, if a CE is being purchased to run DNA sequencing samples, then the system purchased will need to include a fluorescence detector. The main vendors for CEs have similar options for their CE instruments reducing the utility of DQ protocols. Their main utility is to define the specific equipment needed for the purchase order. This only needs to be performed before the system is purchased initially. If desired, this can also be done when additional features need to be purchased (i.e., new detectors, etc.). 

The computer system attached to the instrument provides instrument control, data acquisition, data processing, and reporting. According to the draft Analytical Instrument Qualification chapter of the United States Pharmacopoeia (USP) <1058> The manufacturer should perform design qualification, validate the software and provide users with a summary of the validation. At the user site, holistic qualification that involves the entire instrument and software system is more efficient than modular validation of the software alone. Therefore the user qualifies the instrument control, data acquisition and processing software by qualifying the instrument. ... 

Design qualification (DQ)—documented verification that the proposed design of the system is suitable for the intended purpose. 

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. 

To provide the guideline for the preparation of validation master plan to meet the design qualification requirement... 

Design qualification is documented evidence that quality is built into the design of facilities and operations. 

The standard of any facility of operation is highly dependent upon the quality of the design and, therefore, the staff employed to undertake the work. A design qualification protocol, or report document, should detail and record the disciplined, structured approach followed. This will provide a useful lead into the installation qualification (IQ) stage. 

Design Qualification Guideline for Minimizing the Risk of Product Cross-Contamination by Air Handling System... 

Design Qualification Guideline for HVAC System of a Pharmaceutical Plant... 

Design Qualification for the Prevention of Contamination of Non-Sterile Pharaceutical Products... 

Design Qualification Guideline for Cross-Contamination and Decontamination... 

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