Good Manufacturing Practices for PharmaceuticalsJoseph D. Nally CRC Press, 19 Apr 2016 - 424 halaman With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings. |
Isi
| 1 | |
General Provisions Subpart A | 13 |
Subpart B | 25 |
Subpart C | 37 |
Subpart D | 51 |
Subpart E | 71 |
Subpart F | 83 |
Subpart G | 115 |
Chapter 16 Contracting and Outsourcing | 239 |
Chapter 17 Active Pharmaceutical Ingredients | 251 |
Chapter 18 Bulk Pharmaceutical Excipient GMPs | 259 |
CGMP Enforcement Alternatives in the United States | 269 |
Chapter 20 Controlled Substances Safeguards 21 CFR 1300 et seq | 281 |
The Regulatee Is Inspected The Rationale for Inspection 21 USC 373 374 | 285 |
The Road from ScaleUp and PostApproval Changes to the Food and Drug Modernization Act | 319 |
Chapter 23 Worldwide Good Manufacturing Practices | 335 |
Subpart H | 143 |
Subpart I | 149 |
Subpart J | 169 |
Subpart K | 199 |
Chapter 13 Repacking and Relabeling | 203 |
Chapter 14 Quality Systems and Risk Management Approaches | 215 |
Chapter 15 Clinical Trial Supplies and Current Good Manufacturing | 227 |
Edisi yang lain - Lihat semua
Good Manufacturing Practices for Pharmaceuticals, Sixth Edition Joseph D. Nally Pratinjau tidak tersedia - 2006 |
Istilah dan frasa umum
acceptable action active additional adequate agency allow application approach appropriate approval areas assure authority batch calibration cause CGMP chapter cleaning complete compliance components conducted confirm considered container contractor correct defined determine devices distribution document dosage form drug product edited effective ensure equipment established evaluation example excipient facilities failure final firm Food function guidance identified impact important indicate individual industry ingredients initial inspection inspector involved issues labeling laboratory limits maintained maintenance manufacturing materials meet methods necessary operations packaging performed period person personnel Pharmaceutical possible potential practice prevent problem procedures recall records reference regulations regulatory release requirements responsible risk sample specific stability standards sterility storage studies testing unit usually validation written
Bagian yang populer
Halaman 1 - ... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice...
Buku ini dirujuk
Validation of Pharmaceutical Processes James P. Agalloco,Frederick J. Carleton Pratinjau terbatas - 2007 |