Supplier acceptance testing

Supplier acceptance test records and reports for both FAT and SAT should be approved and kept in the validation file. 

It is important that the documentation for supplier acceptance testing is utilized to support the qualification process, therefore, the data provided should be suitable for referencing directly from the IQ and/or OQ Protocol. This is most appropriate where the functionality of the system may not be fully demonstrated following the final installation (typically some alarm/in-terlock and failure mode tests may be difficult to reproduce without risk of damage to the installation external to the computer system). 

At the completion of supplier acceptance testing, a report will be produced, which must be accepted by the pharmaceutical manufacturer prior to shipping the system to the site. There should also be a list of actions that must be performed prior to the commencement of IQ and/or Site Acceptance Testing. 

IQ Testing. A record of the physical installation of the individual computer systems and their interconnections and interfaces is the result of IQ testing. The purpose is to uniquely identify the component parts of the individual systems, hardware, firmware and software and to verify that they were the items utilized in the supplier acceptance testing. It is often the case, however, that due to supplier acceptance failures, there may have been modifications to the software or replacement hardware performed under change control. 

It should be standard practice to begin the IQ process with a backward looking review. This review should assess the outcome of the DQ activities as identified above and the supplier acceptance testing. Where issues have been identified and/or failures recorded, they should be assessed and appropriate action taken to ensure that the IQ process may continue. Any decisions made by the IQ tester and witness regarding these actions should be recorded in the IQ protocol. Table 6.2 represents the information typically recorded in IQ tests/inspections. 

User Acceptance Testing (UAT). UAT provides the pharmaceutical manufacturer with the final demonstration of computer system functionality. In the OCS, there will be confirmation that the individual systems operate as expected this will normally be a repeat of some or all of the tests in the supplier acceptance test specification. Following satisfactory demonstration of the individual systems, testing of the interfaces will be performed by the system integrator. Clearly the demonstration of the functionality in UAT is the same as is required for OQ testing, and the two activities should therefore run in parallel. The possible requirements for the on-site OQ are given in Table 6.3. 

Visual inspection of major hardware components Approved Supplier Acceptance Test Report... 

The key phrase in this clause is or otherwise verified as it allows you to receive product into your company and straight onto the production line if you have verified that it conforms to the specified requirements before it arrives. An example of this is where you have performed acceptance tests or witnessed tests on the supplier s premises. You may also have obtained sufficient confidence in your supplier that you can operate a Just-in-time arrangement but you must be able to show that you have a continuous monitoring program which informs you of the supplier s performance. 

Containers and closures shall be tested for conformance with all appropriate written procedures. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier s test results through appropriate validation of the supplier s test results at appropriate intervals. 

DQ is performed by the supplier of the equipment or system at the supplier s factory as part of the factory acceptance test (FAT). IQ (based on site acceptance test—SAT), OQ, and PQ are performed on-site at the GMP facility. For a GMP manufacturing facility, the validation activities include the facility design, FTVAC system, environment control, laboratory and production equipment, water system, gases and utilities, cleaning, and analytical methods. Validation protocols (IQ, QQ, and PQ) are prepared for each item, listing all critical steps and acceptance criteria. Deviations are reviewed and resolved before the validation activity proceeds to the next phase. 

The FDS will also form the basis for contractual acceptance testing, both at the supplier s premises (factory acceptance test, FAT) and on delivery to the site (site acceptance test, SAT). With suitably compiled test procedures these traditional contractual acceptance tests may be incorporated with the qualification testing required by the validation life cycle. 

For a stand-alone system the computer system normally undergoes factory acceptance testing at the supplier s premises, and as with associated instrumentation and regulating devices is shipped to the site, inspected, and where applicable is stored and then installed with the manufacturing process/plant equipment. 

The supplier will normally apply GEP in covering the two parts of this contractual acceptance test, namely FAT and SAT. However, and if required by the pharmaceutical manufacturer, it should be possible to structure acceptance testing to include the enhanced level of verification, testing, and documentation that are necessary for the in situ qualification under the validation life cycle. 

This is normally the first stage of system acceptance testing and should be witnessed by the pharmaceutical manufacturer prior to agreement for the system to be delivered to the site. The supplier should ensure that the system can pass the predefined tests prior to the witnessed acceptance testing so as to minimize the risk of any retesting. The supplier may be requested to produce records of... 

The FAT is normally a contractual acceptance test that serves to ensure that within the limitations of testing available at the supplier s premises the system operates satisfactorily, and for any problems identified during testing has the advantage of being directly resourced and resolved in the development environment. Problems (particularly software-related) carried over or detected on site are invariably more difficult and time-consuming to rectify. 

Any additional test data must be identified and appended to the test results. As appropriate, design reviews and the development and acceptance testing undertaken and documented by the supplier may be utilized to support the qualification effort and to optimize the resources required to achieve validation. 

Factory Acceptance Test (FAT) An acceptance test in the supplier s factory, usually involving the customer (IEEE). 

The FAT, Figure E-2, is a mutually agreed acceptance test of the system between the supplier/developer and the user. It is performed by the computer technology supplier/developer at the supplier s/developer s site. The user will often witness this test to accept the system for delivery and to mark a contractual milestone. 

The SAT is an acceptance test comprising system installation, start-up, operational testing, and handover to customer, performed by the supplier/ integrator in the operational environment. As with the FAT, the user s representative should witness the tests and evaluate the results of the SAT. 

The specification writer must try to put into the specification the requirements that, if met, will provide the greatest likelihood of success. These requirements should be standard tests and acceptable test limits that are agreed upon by both the supplier and the user. The tests should be indicative of how the adhesive is used in production and how the finished joint is to be used in service. Tests that are not directly applicable to the specific application should not be included. Tests should not be used simply because they are standard test methods or have been used in the past. 

System is in the intended baseline state in accordance with defined milestones (e.g., for supplier testing, at installation, for nser acceptance testing, and for nse)... 

Confirmation that all tests or verification were executed and witnessed (if applicable) by suitably qualified and authorized personnel. This includes all supplier factory testing and site acceptance testing... 

The operational qualification is carried out after the IQ and is intended to demonstrate that the application works the way the suppher says it will. Most suppliers will supply OQ scripts. These, of necessity, will only cover a subset of functions and will not be a substitute for the user acceptance tests or PQ tests. 

Suppliers conduct factory and site acceptance testing (FAT, SAT). Testing carried out at the factory includes hardware and software tests. Successful completion of the tests allows shipment of the IPC system to site. Tests include ... 

Custom (bespoke) hardware components All requirements for category 1, plus. .. Design specification required Subject to acceptance testing Supplier audit for hardware development Assembled systems from different sources require verification of compatibility Configuration defined in design documents... 

Conversely, if the supplier s Quality Management System is very well written and there is documented evidence that the supplier adheres to it, the definition of risk levels might be relaxed a bit in the Function Risk Assessment. If the supplier s own acceptance testing is well documented and thorough, the Validation Plan should document the intent to reference some of the supplier testing in lieu of internal tests. It is not necessary to specify exact tests to be used at this point that can wait until the test plans are being prepared later on. 

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