{ENGLISH} CHAPTER 4S2 RISK BASED C&Q – END

 

CHAPTER 4S2 RISK BASED C&Q – END

 

7. DQ Record

DQ record consists of a checklist and reference documents, including reference specifications and reference drawings.

DQ checklist and record format include the following:

Test item Description of test item Test result: what has been seen and the judgment (pass or fail), with notes as follows: The test results must be handwritten The reference documents should be listed and attached

IQ and/or OQ record format is similar to the DQ record format.

 

8. FAT (Factory Acceptance Test) and SAT (Site Acceptance Test)

According to EU GMP Annex 15 about the implementation of FAT and/or SAT is as follows.

Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery Prior to installation, equipment should be confirmed to comply with the URS/functional specification at the vendor site, if applicable Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on-site at IQ/OQ if it can be shown that the functionality is not affected by the transport and installation FAT may be supplemented by the execution of an SAT following the receipt of the equipment at the manufacturing site

The benefits of FAT are as follows.

It is easy to adjust or retest with the equipment which is not easy at the destination site after delivery Foreseeable obstacle to IQ or OQ, can be treated properly before delivery The result that is not affected by moving can be used as IQ/OQ data. For the reasons above, FAT can reduce both the validation period and validation cost

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