I. GMP Guideline for Drug Products: Text - NIHS

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添付資料 4 GMP Guideline for Drug Productsfor raw materials and packaging/labeling materials should be appropriatelyidentified.7.24 Each container or group of containers containing raw materials andpackaging/labeling materials should be assigned and identified with a distinctivelabeling. The labeling should provide at least the following information, and beused in changing the location of each lot. A system should be available in placeto identify the status of each lot.1) Product name;2) Lot number of control number;3) Control condition of contents (information such as “under isolation,” “undertesting,” “accepted,” “rejected,” “returned material,” “recalled material” etc.);and4) Where applicable, information on expiry date or the date when re-test becomesnecessary.When a completely computerized storage system for raw materials andpackaging/labeling materials is employed, it is not necessary for the system tomake all the above information readable.7.25 For lot numbers or control numbers to be given to the received raw materials andpackaging/labeling materials, attention should be paid to the following:1) Even in the case of identical lot at the supplier, if the lot is received ininstallments, an independent lot number or control number should be given atthe time of receipt.2) Even when the lot number or control number are the same, when the lot isplaced in two or more containers, a control method should be required tospecify each container, if necessary.7.3 Sampling and Testing of Incoming Raw Materials and Packaging/LabelingMaterials7.30 Raw materials and packaging/labeling materials should be tested per lot or controlunit, with the exception described in Chapter 7.32. A supplier's Certificate ofAnalysis can be used in place of a part of tests, provided that the manufacturer hasa system to evaluate suppliers.7.31 Suppliers should be approved based on sufficient evidence (e.g., results ofevaluation of suppliers, quality histories of raw materials and packaging/labelingmaterials supplied in the past) for consistent supply of raw materials andpackaging/labeling materials that meet specifications. When intended to omitpart of items of in-house testing upon receipt (hereinafter referred to as“acceptance testing”), at least 3 lots or 3 control units should be tested in advanceon full analyses to ascertain the validity. Even when part of acceptance testinghas been omitted, full analysis should be performed at appropriate intervals toascertain the reliability of the suppliers’ Certificates of Analysis.7.32 When opening the containers of raw materials and packaging/labeling materials for26
添付資料 4 GMP Guideline for Drug Productssampling for acceptance testing affects the quality of the materials, test resultsdescribed in suppliers’ proper Certificates of Analysis can be used for a part ofacceptance testing. In case that acceptance testing is omitted, the reason shouldbe explained appropriately and described in the quality control standard code.7.33 Samples should be representative of the lot or control unit. The number ofcontainers to be sampled, sampling points in the containers and sampling amountshould be predefined in the sampling plan in consideration of criticality of therelevant raw materials and packaging/labeling materials, quality variability, qualityhistories of materials supplied in the past by the relevant suppliers, and quantityneeded for proper testing.7.34 Sampling should be conducted at predefined locations by procedures designed toprevent contamination of the sampled raw materials and packaging/labelingmaterials as well as contamination of other materials.7.35 Samples should be collected by the following procedure:1) The container from which samples are collected should be made clean beforesample collection, when necessary.2) Containers from which samples are collected should be opened carefully, andreclosed immediately after sampling.3) Sterile instruments and sterile methods for sampling should be employed,when necessary.4) When a sample has to be collected from the top, middle and bottom ofcontainer, the samples collected should not be mixed with each other.5) To avoid mix-up of samples, the container in which the samples are placedshould have labeling that describes the name of sampled raw materials orpackaging/labeling materials, lot number or control number, container fromwhich the samples were collected, sampling date, and person who sampled.6) Containers from which samples were collected should be marked to indicatethat samples were collected from the relevant containers.7.4 Storage7.40 Raw materials or packaging/labeling materials should be handled and stored in amanner to prevent degradation, contamination, and cross-contamination.7.41 Containers for storage of raw materials or packaging/labeling materials should beplaced off the floor and suitably spaced to permit cleaning and testing.7.42 Raw materials or packaging/labeling materials should be stored under properconditions for a suitable period to assure their quality, and should be controlled sothat the oldest stock is used first, except for particular cases.7.43 Rejected raw materials or packaging/labeling materials should be properlyidentified and stored under quarantine to prevent mix-up of use in manufacturingprocesses.27
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