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ICH Titles

 

 

EU & Canadian Titles

1 - General enforcement regulations       ICH Q1A (R2) - Stability Testing of New Drug Substances and Products      
2 - General administrative rulings and decisions       Q1B Stability Testing : -  Photostability Testing of New Drug Substances and Products      
3 - Product jurisdiction       Q1C  - Stability Testing for New Dosage Forms      
5 - Organization       Q1D  - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products      
7 - Enforcement policy       ICH Q1E  - Evaluation of Stability Data      
10 - Administrative practices and procedures       Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV      
11 -  Electronic records; electronic signatures       Q2(R1) New title: Validation of Analytical Procedures: Text and Methodology
Previously: Text on Validation of Analytical Procedures
     
11+ - 11 with Preambles     Q2A
Validation of Analytical Procedures: Methodology (in Q2(R1)) Q2B
     
11+ - 11 Spanish     Q3A(R2) Impurities in New Drug Substances
Q3A(R)
     
12 -  Formal evidentiary public hearing       Q3B(R2) Impurities in New Drug Products
Q3B(R)
     
13 - Public hearing before a public board of inquiry              
14 - Public hearing before a public advisory committee              
15 - Public hearing before the Commissioner              
16 - Regulatory hearing before the Food and Drug Administration              
17 - Civil money penalties hearings              
19 - Standards of conduct and conflicts of interest              
20 - Public information              
21 - Protection of privacy              
25 - Environmental impact considerations              
26 - Mutual recognition of pharmaceutical good manufacturing practice reports, medical device quality system audit reports, and certain medical device product evaluation reports: United States and The European Community              
50 - Protection of human subjects       ICH Q2B -      
54 - Financial disclosure by clinical investigators       ICH Q5E -      
56 - Institutional Review Boards       ICH Q7A -      
58 - Good laboratory practice for nonclinical laboratory studies       ICH Q8 -      
60 - Patent term restoration       ICH Q9 -

 

     
70 - Color additives       ICH E2A -      
71 - Color additive petitions      
ICH E2B -

 

     
73 - Listing of color additives exempt from certification       ICH E4 -      
74 - Listing of color additives subject to certification       ICH E8 -

 

     
80 - Color additive certification       ICH S2A -      
81 - General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics       ICH S6 -      
82 - Listing of certified provisionally listed colors and specifications       ICH S7 -      
99 - Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices               
100  - General              
101 - Food labeling              
102 - Common or usual name for nonstandardized foods              
104 - Nutritional quality guidelines for foods              
105 - Foods for special dietary use              
106 - Infant formula quality control procedures              
107 - Infant formula              
108 - Emergency permit control              
109 - Unavoidable contaminants in food for human consumption and food-packaging material              
110 - Current good manufacturing practice in manufacturing, packing, or holding human food              
110+ - 110 Spanish            
111 - 111 Good Manufacturing Practices for Dietary Supplement            
113 - Thermally processed low-acid foods packaged in hermetically sealed containers              
114 - Acidified foods              
115 - Shell eggs              
119 - Dietary supplements that present a significant or unreasonable risk              
120 - Hazard Analysis and Critical Control Point (HACCP) systems              
123 - Fish and fishery products              
129 - Processing and bottling of bottled drinking water              
130 - Food standards: General              
131 - Milk and cream              
133 - Cheeses and related cheese products              
135 - Frozen desserts              
136 - Bakery products              
137 - Cereal flours and related products              
139 - Macaroni and noodle products              
145 - Canned fruits              
146 - Canned fruit juices              
150 - Fruit butters, jellies, preserves, and related products              
152 - Fruit pies              
155 - Canned vegetables              
156 - Vegetable juices              
158 - Frozen vegetables              
160 - Eggs and egg products              
161 - Fish and shellfish              
163 - Cacao products              
164 - Tree nut and peanut products              
165 - Beverages              
166 - Margarine              
168 - Sweeteners and table syrups              
169 - Food dressings and flavorings                 
170 - Food additives              
171 - Food additive petitions              
172 - Food additives permitted for direct addition to food for human consumption              
173 - Secondary direct food additives permitted in food for human consumption              
174 - Indirect food additives: General              
175 - Indirect food additives: Adhesives and components of coatings              
176 - Indirect food additives: Paper and paperboard components              
177 - Indirect food additives: Polymers              
178 - Indirect food additives: Adjuvants, production aids, and sanitizers              
179 - Irradiation in the production, processing and handling of food              
180 - Food additives permitted in food or in contact with food on an interim basis pending additional study              
181 - Prior-sanctioned food ingredients              
182 - Substances generally recognized as safe              
184 - Direct food substances affirmed as generally recognized as safe              
186 - Indirect food substances affirmed as generally recognized as safe              
189 - Substances prohibited from use in human food              
190 - Dietary supplements                  
200 - General              
201 - Labeling              
202 - Prescription drug advertising              
203 - Prescription drug marketing              
205 - Guidelines for State licensing of wholesale prescription drug distributors              
206 - Imprinting of solid oral dosage form drug products for human use              
207 - Registration of producers of drugs and listing of drugs in commercial distribution              
208 - Medication Guides for prescription drug products              
210/211 - Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general  
  Current good manufacturing practice for finished pharmaceuticals  
           
210/211 - 210/211 Spanish            
210/211 - 210/211 with Keyword Index            
210/211 - 210/211 with Preambles            
216 - Pharmacy compounding              
225 - Current good manufacturing practice for medicated feeds              
226 - Current good manufacturing practice for Type A medicated articles              
250 - Special requirements for specific human drugs              
290 - Controlled drugs              
299 - Drugs; official names and established names                 
300 - General              
310 - New drugs              
312 - Investigational new drug application              
314 - Applications for FDA approval to market a new drug              
315 - Diagnostic radiopharmaceuticals              
316 - Orphan drugs              
320 - Bioavailability and bioequivalence requirements              
328 - Over-the-counter drug products intended for oral ingestion that contain alcohol              
330 - Over-the-counter (OTC) human drugs which are generally recognized as safe and effective and not misbranded              
331 - Antacid products for over-the-counter (OTC) human use              
332 - Antiflatulent products for over-the-counter human use              
333 - Topical antimicrobial drug products for over-the-counter human use              
335 - Antidiarrheal drug products for over-the-counter human use              
336 - Antiemetic drug products for over-the-counter human use              
338 - Nighttime sleep-aid drug products for over-the-counter human use              
340 - Stimulant drug products for over-the-counter human use              
341 - Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use              
343 - Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use              
344 - Topical OTIC drug products for over-the-counter human use              
346 - Anorectal drug products for over-the-counter human use              
347 - Skin protectant drug products for over-the-counter human use              
348 - External analgesic drug products for over-the-counter human use              
349 - Ophthalmic drug products for over-the-counter human use              
350 - Antiperspirant drug products for over-the-counter human use              
352 - Sunscreen drug products for over-the-counter human use [stayed indefinitely]              
355 - Anticaries drug products for over-the-counter human use              
357 - Miscellaneous internal drug products for over-the-counter human use              
358 - Miscellaneous external drug products for over-the-counter human use              
361 - Prescription drugs for human use generally recognized as safe and effective and not misbranded: Drugs used in research              
369 - Interpretative statements re warnings on drugs and devices for over-the-counter sale                 
500 - General              
501 - Animal food labeling              
502 - Common or usual names for nonstandardized animal foods              
509 - Unavoidable contaminants in animal food and food-packaging material              
510 - New animal drugs              
511 - New animal drugs for investigational use              
514 - New animal drug applications              
515 - Medicated feed mill license              
520 - Oral dosage form new animal drugs              
522 - Implantation or injectable dosage form new animal drugs              
524 - Ophthalmic and topical dosage form new animal drugs              
526 - Intramammary dosage forms              
529 - Certain other dosage form new animal drugs              
530 - Extralabel drug use in animals              
556 - Tolerances for residues of new animal drugs in food              
558 - New animal drugs for use in animal feeds              
564 - [Reserved]              
570 - Food additives              
571 - Food additive petitions