I. GMP Guideline for Drug Products: Text - NIHS

More documents

Recommendations

Info

$Allergies to cross-reactive plant proteins. Latex-fruit ... - NIHS$

添付資料 4 GMP Guideline for Drug Products7.5 Re-evaluation7.50 Raw materials or packaging/labeling materials should be re-evaluated asappropriate to determine their suitability for use (e.g., after prolonged storage overpredefined period or exposure to heat or humidity).28
添付資料 4 GMP Guideline for Drug Products8 Production and In-Process Controls8.1 Manufacturing Operations8.10 Prior to starting the manufacturing operations, it should be confirmed that theworking areas and equipment are clean, and that raw materials, products, anddocuments that are not needed for the relevant operations do not remain there.Appropriate measures should be taken when necessary.8.11 Raw materials for manufacturing products should be weighed or measured underappropriate conditions that do not affect the product suitability. Weighing andmeasuring devices should be of suitable accuracy for the intended use.8.12 If raw materials are subdivided for later manufacturing processes, appropriatecontainers should be used to receive the materials, and the following informationshould be labeled on the containers:- Name, lot number or control number of the raw material;- Subdividing number, when necessary;- Weight or volume of the raw material in the container; and- Where applicable, information on expiry date or dates when re-testingbecomes necessary8.13 Critical weighing, measuring, or subdividing should be witnessed by a person otherthan those who perform the operations, or be controlled under the equivalent levelof conditions. Prior to use, the personnel who perform operations should verifythat the raw materials are those specified in the manufacturing instructions for theintended product.8.14 Other critical operations should be witnessed by a person other than those whoperform the operations, or be controlled under the equivalent level of conditions.8.15 Actual yields should be compared with expected yields at predefined steps in themanufacturing processes. Expected yields with appropriate ranges should beestablished based on laboratory data, pilot-scale data or production data.Deviations in yields associated with critical processes should be investigated todetermine their effect or potential effect on the resulting quality of affected lots.8.16 The processing status of major units of equipment should be indicated either on theindividual units of equipment or by appropriate documentation, computerizedcontrol systems, or alternative means.8.17 The intermediate products excluded from the manufacturing process (materialsexcluded from the process) should be controlled with clear differentiation from theproducts accepted in the process.8.18 Any disposal of materials excluded from the process should be recorded. In casethat materials excluded from the process are re-processed, the procedure shouldfollow the provision of Chapter 14.2 (Reprocessing).29
Page 1 and 2: 添付資料 4 GMP Guideline for
Page 27: 添付資料 4 GMP Guideline for
Page 79 and 80:
添付資料 4 GMP Guideline for
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
添付資料 5 Guideline for Tec
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Global Regulatory GMP Conference -
Page 117 and 118:
Login Logout Sitemap Search About I
show all

I. GMP Guideline for Drug Products: Text - NIHS

Create successful ePaper yourself

Delete template?

Save as template?