| 000 | 03163cam a22003974i 4500 | ||
|---|---|---|---|
| 999 |
_c12885 _d12885 |
||
| 001 | 12117435 | ||
| 005 | 20210307113512.0 | ||
| 008 | 000724s2001 nyua b 001 0 eng | ||
| 010 | _a 00060188 | ||
| 020 | _a0824704258 (alk. paper) | ||
| 040 |
_aDLC _cDLC _dDLC _erda |
||
| 042 | _apcc | ||
| 043 | _an-us--- | ||
| 050 | 0 | 0 |
_aRS189 _b.W57 2000 |
| 082 | 0 | 0 |
_a615.190685 _222 _bW.S.G |
| 100 | 1 |
_aWillig, Sidney H., _d1919-, _eauthor. |
|
| 245 | 1 | 0 |
_aGood manufacturing practices for pharmaceuticals : _ba plan for total quality control from manufacturer to consumer / _cSidney H. Willig. |
| 250 | _aFifth edition, revised and expanded | ||
| 264 | 1 |
_aNew York : _bMarcel Dekker Inc., _c[2001] |
|
| 264 | 4 | _c©2001 | |
| 300 |
_axii, 732 pages : _billustrations (black and white); _c24 cm |
||
| 336 |
_2rdacontent _atext |
||
| 337 |
_2rdamedia _aunmediated |
||
| 338 |
_2rdacarrier _avolume |
||
| 490 | 1 |
_aDrugs and the pharmaceutical sciences ; _vv. 109 |
|
| 504 | _aIncludes bibliographical references and index. | ||
| 505 | _aStatus and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holdings of DrugsFinished Pharmaceuticals: General Provisions (Subpart A)Organization and Personnel: (Subpart B)Buildings and Facilities: (Subpart C)Equipment: (Subpart D)Control of Components and Drug Product Containers and Closures (Subpart E)Production and Process Controls (Subpart F)Packaging and Labeling Controls (Subpart G)Holding and Distribution: (Subpart H)Laboratory Controls (Subpart I)Records and Reports (Subpart J)Returned and Salvaged Drug Products (Subpart K)Repacking and RelabelingBulk Pharmaceutical ChemicalsThe Pharmacist and Total Quality ControlRecalls and CGMPs: Enforcement Alternatives in the United StatesControlled Substances Safeguards (21 CFR 1300, et seq.) The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected;The Rationale for Inspection (21 USC 373,374)FDA Pre-Approval Inspections/Investigations; The Road from SUPAC to the Food and Drug Modernization ActWho is the Manufacturer? Some Additional Considerations for the MultinationalOther GMPsOther Approaches to QualityImport and Export of Pharmaceuticals and Other ProductsSubject to CGMPsEnhancement of Global Product DistributionAppendix A: Food and Drug Modernization Act of 1997-in Pertinent PartAppendix B: Components/RepackagersAppendix C: Hearing Procedures When FDA Proposes the Imposition of Civil Money PenaltiesAppendix D:Section 601.12 Changes Currently Considered "Important" by CBERAppendix E: USP24-NF19 Information; Monographs; Tests | ||
| 650 | 0 |
_aPharmaceutical industry _xQuality control. |
|
| 650 | 0 |
_aDrugs _xStandards _zUnited States. |
|
| 830 | 0 | _tDrugs and the pharmaceutical sciences | |
| 856 | 4 | 2 |
_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0647/00060188-d.html |
| 906 |
_a7 _bcbc _corignew _d1 _eocip _f20 _gy-gencatlg |
||
| 942 |
_2ddc _cBK |
||