Good Manufacturing Practices for PharmaceuticalsJoseph D. Nally 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. |
Contents
| 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 |
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Good Manufacturing Practices for Pharmaceuticals, Sixth Edition Joseph D. Nally No preview available - 2006 |
Common terms and phrases
action active ingredient agency analytical approach appropriate approval areas audit batch production batch record bulk calibration CGMP CGMP regulations Chapter cleaning Clinical closures components contractor Current Good Manufacturing defined devices dietary supplements distribution document dosage form Drug Applications drug product containers edited effective electronic ensure equipment established evaluation excipient expiration date facilities failure FDA’s Federal Federal Food firm guidance guidelines homeopathic identified impact in-process industry initial inspection inspector investigation Issued labeling laboratory maintenance Manufacturing Practice methods monitoring operations OTC drug packaging packaging and labeling performed personnel Pharmaceutical potential process validation product quality quality assurance quality control quality systems recall regulatory release repackers requirements responsible risk samples Six Sigma specific stability standards sterility storage supplier tablets tamper-evident tamper-resistant testing unit United States Pharmacopeia written procedures
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Page 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...