I. GMP Guideline for Drug Products: Text - NIHS

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添付資料 4 GMP Guideline for Drug Productsunits of measure, conversion coefficients, and equivalency coefficients;6) Descriptions about the evaluation of test results and the comparison withacceptance criteria;7) Signatures or seals of persons who performed each test and dates when thetests were performed; and8) A signature or seal of a responsible person in the quality unit and the date toshow that the original records have been reviewed for accuracy, completeness,and compliance with established specifications.6.61 Complete records should be maintained for:1) Any modifications to established analytical methods;2) Periodic calibration of laboratory instruments, apparatus, gauges, andrecording devices;3) All stability testing performed on products; and4) Out-of-specification (OOS) investigations24
添付資料 4 GMP Guideline for Drug Products7 Control of Raw Materials and Packaging/Labeling Materials7.1 General Controls7.10 The quality control standard codes defined in Article 8, Paragraph 3 of the GMPMinisterial Ordinance for Drugs and Quasi-drugs should include descriptions aboutreceipt, identification, storage, handling, sampling, testing, procedure for approvalor rejection, and reassessment of raw materials and packaging/labeling materials.7.11 A system for assessment of suppliers of critical raw materials andpackaging/labeling materials should be provided.7.12 Raw materials and packaging/labeling materials should be purchased fromsuppliers approved by the quality unit, and only those that conform with thepredefined specifications should be accepted.7.13 If a supplier of critical raw materials or packaging/labeling materials is not itselfthe manufacturer of them, the name and address of the manufacturer of the relevantraw materials or packaging/labeling materials with their quality information shouldbe provided.7.14 Change of suppliers of critical raw materials and packaging/labeling materialsshould be treated as defined in Chapter 13 (Change Control).7.2 Receipt and Quarantine of Raw Materials and Packaging/Labeling Materials7.20 Upon receipt and before approval of use, visual inspection should be performed tocheck labeling of each container or group of containers of raw materials andpackaging/labeling materials (including description of correlation between thelabeling by suppliers and the in-house labeling, if they are different), containerdamage, broken seals and evidence of tampering or contamination. Raw materialsand packaging/labeling materials should be held under quarantine during samplecollection and required testing, and until approved for release for use.7.21 In case that newly received raw materials and packaging/labeling materials are tobe blended with existing stocks (e.g., solvents in a large volume storage tank), theincoming materials should be tested in advance and identified as appropriate, andthen blended. Procedures should be available to prevent inadequate mix-up ofincoming raw materials and packaging/labeling materials with existing stocks.7.22 In case that raw materials and packaging/labeling materials are transported bynon-dedicated tankers, confirm that no cross-contamination occurs in the tankers.Confirmation method can include the following:- Certificate of cleaning- Testing for minute impurities- Onsite audit of the supplier7.23 Large volume storage containers, their equipped piping, filling and discharge lines25
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