| Title |
WHO Expert Committee On Specifications For Pharmaceutical Preparations |
| Collection Location |
Analis Kesehatan |
| Edition |
Forty-Fourth report |
| Call Number |
615 Who 2010 |
| ISBN/ISSN |
978-924-120-957 1 |
| Author(s) |
World Health Organization
|
| Subject(s) |
Pharmaceutical Preparations
|
| Classification |
615 |
| Series Title |
Technology,Pharmaceuticals Standards |
GMD |
Buku Teks |
| Language |
English |
| Publisher |
WHO |
| Publishing Year |
2010 |
| Publishing Place |
Geneva Switzerland |
| Collation |
xi, 276 hlm.; 24 cm. |
| Abstract/Notes |
The expert Committee on Specificatios for Pharmaceutical Preparations Works Towards clear,independent and practical standards and guielines for the quality assurance of medicines. Standar are develoved by the Committee through worldwide consultation and an international conesensus-building process. The Following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality controllaboratories; supplementary guidelines for active pharmaceutical ingridients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products;guidelines on the requalification of prequalified dossiers; and quidelines for the preparation of a contract resarch organization master file. |
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