Qualification vendor

Some mention must be made of recent extensions to the jargon of validation design qualification, vendor qualification, and construction qualification are all terms that have come into use within the last 10 years. Depending upon the scope of the project, these activities have some merit. They should all be considered as options and employed where appropriate. Their overuse can lead to the types of bloated efforts mentioned earlier only the very largest efforts can benefit from these programs. Briefly, these activities embrace the following ... 

The first section is site qualification. Vendors selected to perform regulated work product will be evaluated for compliance with the appropriate s et of regulations. The results of the audit will be reviewed and the need for a site follow-up visit will be determined. Site qualification visits are generally performed on a cyclical basis at least once every 24 months is suggested unless the supplier becomes problematic. A continuous monitoring program is an essential component of a compliant vendor qualification program. 

Key words Validation Qualification Vendors Computers Analytical laboratories... 

Qualification Vendor must provide procedures and services for IQ and OQ... 

Regular internal audits of GMP operations should be conducted according to an audit master schedule. Records of the findings and any follow-up actions should be maintained. Audits of key suppliers should also be conducted as part of a vendor qualification programme. 

Installation qualification (IQ). IQ demonstrates that the equipment/system has been installed correctly at the user site according to vendor standards. The vendor should install the equipment to demonstrate to the buyer that all the components are operating properly. The qualification process includes appropriate documentation of the system components, physical installation and hook-up, and a performance check to verify that the individual components operate and can communicate with each other. System component information, such as serial numbers, type of use, and user performance requirements, should be included in the metrology database for easy tracking and scheduling of maintenance and/or calibration. 

Will vendor perform installation qualification and provide the documentation for this ... 

Labor time charge entry and reporting Customer account charging and/or billing Inventoried product data for order entry processing QC test data for feedstock purchasing and vendor qualification... 

To ensure that equipment is fit for its intended purpose, there is a series of qualifying steps that the analyst or vendor should apply to analytical instrumentation (3,4). Equipment can be evaluated through a series of tests or procedures designed to determine if the system meets an established set of specifications governing the accepted operating parameters. The successful completion of such tests justifies that the system operates and performs as expected. There are four components of instrument qualification design, installation, operational, and performance. 

C. During operational qualification the analyst or vendor would assess if the equipment works as specified, generating appropriately documented data. The procedures will verify that the instrument s individual operational units are functioning within a given range or tolerance, reproducibly. For the dissolution apparatus, the water bath temperature and spindle assembly and shaft rpm speed would be obvious operational parameters. 

If the equipment is a commercial product, the installation and operational qualifications can be obtained from the equipment vendor. This would include the vendor specifications and... 

Installation Qualification—The IQ is the protocol that verifies that the installation of the system has followed the guidelines established within the validation plan and is in accordance with the vendor s installation requirements. 

Operational Qualification—The OQ is the protocol that verifies that the operation of the system meets the written and pre-approved performance and functional specifications established by the vendor within its required operating range. 

Following pre-installation qualification and the actual installation of an HPLC system, both the IQ and the OQ protocols should be implemented, back to back, soon after the installation. Again, the IQ is used to verify that the installation of the system was successful, with all instrument components powering-up properly. The OQ follows, verifying that the system components perform as they were functionally specified by the vendor. Finally, the PQ protocol serves to verify that the system as a whole performs to the URS established by the user and within the functional limitations of the system as a whole. As part of the PQ, it is recommended to test the system as a whole, called holistic validation. This... 

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.). 

Apart from the qualification dossiers provided by vendors there seems, at present, to be very little information published on the performance of an operational qualification for capillary electrophoresis (CE) instruments other than a chapter in Analytical Method Validation and Instrument Performance. The chapter, written by Nichole E. Baryla of Eli Lilly Canada, Inc, discusses the various functions (injection, separation, and detection) within the instrument and provides guidance on the type of tests, including suggested acceptance criteria, that may be performed to ensure the correct working of the instrument. These include injection reproducibility and linearity, temperature and voltage stability, detector accuracy, linearity, and noise. 

Quality control data for vendor qualifications. -Quality control data for incoming raw materials. 

When new equipment is purchased or there is a change in the manufacturing site, qualification exercises are performed as part of the validation process. Qualification (installation qualification, operation qualification, and performance qualification) for any equipment or facility is an extreme process which involves testing, verification, and documentation to assure that the particular equipment or facility is per the specification and meets the appropriate standards as defined by vendor and required by manufacturing and engineering personnel [14]. 

In the control of outsourced operations, the cGMP regulations require that the QU approve or reject products or services provided under a contract. Under current quality system models, the organization must follow a formal vendor qualification process to qualify outsource providers and verify through inspection or other appropriate means that the provider is capable of meeting the requirements of the organization. To comply with the regulation, these operations should be conducted by the QU. 

The information in this chapter applies specifically to the first element sample preparation. The sample preparation steps are usually the most tedious and labor-intensive part of an analysis. By automating the sample preparation, a significant improvement in efficiency can be achieved. It is important to make sure that (1) suitable instrument qualification has been concluded successfully before initiation of automated sample preparation validation [2], (2) the operational reliability of the automated workstation is acceptable, (3) the analyte measurement procedure has been optimized (e.g., LC run conditions), and (4) appropriate training in use of the instrument has been provided to the operator(s). The equipment used to perform automated sample preparation can be purchased as off-the-shelf units that are precustomized, or it can be built by the laboratory in conjunction with a vendor (custom-designed system). Off-the-shelf workstations for fully automated dissolution testing, automated assay, and content uniformity testing are available from a variety of suppliers, such as Zymark (www.zymark.com) and Sotax (www.sotax.com). These workstations are very well represented in the pharmaceutical industry and are all based on the same functional requirements and basic principles. 

System qualification. Qualification protocols and the service to execute the qualification protocol may not be included in the cost of the instrument and have to be purchased separately from the instrument vendor. 

Qualification of equipment and validation of computer systems are not one-time events. They start with the definition of the product or project and setting user requirement specifications and cover the vendor selection process, installation, initial operation, ongoing use, and change control. 

In this chapter we guide quality assurance (QA) managers, lab managers, IT personnel, and users of equipment hardware and software through the entire qualification and validation process, from writing specifications and vendor qualification to installation and initial and ongoing operation. The following points are covered ... 

To set the functional and performance specifications, the vendor s specification sheets can be used as guidelines. However, it is not recommended that the vendor s specifications simply be copied because compliance to the functional and performance specifications must be verified later, during operational qualification and performance qualification. Specifying too many functions and/or setting the values too stringently will significantly increase the workload for OQ. 

Vendor specifications are used as acceptance criteria for operational qualification of equipment. Vendors typically define specifications for analytical equipment instruments such that they can be met easily at the time of installation. However, these specifications are so stringent that problems arise after a period of usage of the instruments, and requalification tests fail. 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

Having chosen the analytical instrument or system, Installation Qualification, IQ, should be carried out to ensure that the equipment works the way the vendor or manufacturer specifies it should. IQ should be performed in accordance with a written test protocol with acceptance criteria with certification from the installation engineer, who is suitably qualified. Full written records of all testing carried out should be maintained as well as ensuring that adequate documentation and manuals have been supplied. The latter should include any Health Safety information from vendor or manufacturer. 

Vendors are approved based on [parts qualification report] and performance as to the type of product and service being purchased. Vendor evaluation ensures that the vendor has effective quality system controls. 

Is the equipment to be used newly acquired If so, has it undergone requisite IQ, OQ, and PQ activities If so, how good are the completed packages Before the equipment was received from the vendors, were vendor equipment qualifications (also known as factory acceptance tests—FAT) conducted and were the results satisfactory Are there any outstanding issues requiring resolution Some assumptions will of course be made. These assumptions are listed in Table 5. 

Qualification activities are usually undertaken in order to characterize a facility s services and utilities as well as the equipment that would be used as part of a manufacturing process. As indicated earlier, these activities will include installation and operational activities as part of the validation function. Most companies will issue a report that documents the features of the facility s processing rooms, such as the electrical, water, gas, and HVAC services, for the installation qualification. Table 5 is a generic outline of the items that would be found in the IQ report. Whenever the process equipment is permanendy fixed in these rooms, the report will also list the equipment as well as its operating requirements and features. See Table 6 for an outline of questions that would be used to complete a report, which includes equipment qualification. It is preferred that qualification occur as soon as the equipment or facility is ready for routine operation so that any unexpected results will be corrected by the equipment vendor and/or construction contractor. 

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